[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ivb-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ivb-prostate-cancer-ajcc-v8":604},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,41,66,85,150,171,192,217,246,268,288,309,330,354,375,394,426,447,468,486,504,525,546,565,583],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054118",false,"NCT07698535","Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial","Dynamic Assessments of Molecular Response to Guide Early 177Lu-PSMA-617 Treatment Discontinuation: The DYNAMO Study","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Adult males ≥ 18 years age\n* History of histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine or small cell differentiation. If histology is not available, patients must have metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes)\n* Evidence of metastatic disease on bone scan or CT scan\n* Patient must have evidence of castration- resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 \\[PCWG3\\] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg\u002FdL)\n\n  * Serum\u002Fplasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Prior treatment and progression on at least one androgen receptor pathway inhibitor (ARPI), in either castration-sensitive or castration-resistant setting\n* Eligible for treatment with either 177Lu-PSMA-617 or docetaxel as per their respective Food and Drug Administration (FDA) labels\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine clearance ≥ 50 ml\u002Fmin (calculated by Cockcroft-Gault formula)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome (direct bilirubin ≤ 1.5 x ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN. For patients with known Gilbert's Syndrome they must be ≤ 3 x ULN\n* Able to comply with study requirements including provision of peripheral blood samples at specified time points for correlative studies\n\nExclusion Criteria:\n\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or provision of informed consent to participate in this study\n* Evidence of metastatic neuroendocrine\u002Fsmall cell prostate cancer (NEPC). Note: baseline biopsy is not required\n* Patients receiving any systemic therapy (aside from a luteinizing hormone-releasing hormone \\[LHRH\\] analogue) or radiotherapy within 2 weeks prior to study treatment\n* Persistent toxicities (CTCAE grade \\> 2) from prior cancer therapy, excluding alopecia and stable neuropathy\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or active, uncontrolled infection. Examples include, but are not limited to uncontrolled seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent\n* Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count \\\u003C 200\n* Patients with known active hepatitis (i.e. hepatitis B or C). Prior hepatitis C infection is allowed as long as polymerase chain reaction (PCR) is negative\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery\n* Serious cardiac disorder, including but not limited to uncontrolled ventricular arrhythmia, recent (within 12 months) myocardial infarction, resting electrocardiogram (ECG) indicating Fridericia's corrected QT interval prolongation \\> 500ms, or congenital long QT syndrome\n* Prior systemic chemotherapy with taxane chemotherapy, including in hormone sensitive setting (e.g. docetaxel or cabazitaxel)\n* Brain metastases or active epidural disease (treated epidural disease is permitted)\n\n  * Note: baseline brain imaging is not required\n* Contraindication to prednisone therapy including poorly controlled diabetes mellitus","MALE","18 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This clinical trial studies whether measuring circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction (TF) can be used to help guide the early stopping (discontinuation) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) in patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for the disease to grow, spread, or get worse or come back after a period of improvement. ctDNA TF is a type of ctDNA measurement. Research has shown ctDNA TF may be a promising way to predict which patients will respond to 177Lu-PSMA-617 treatment. Measuring ctDNA TF may help doctors identify which patients may benefit from changing treatments sooner, which may be an effective way to guide early 177Lu-PSMA-617 treatment discontinuation in patients with metastatic castration-resistant prostate cancer.",[26,27],"Metastatic Castration-Resistant Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","NOT_YET_RECRUITING","2026-07-06",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":20},"2026-12-01",{"date":36,"type":20},"2029-07-05",{"name":38,"class":39},"University of Washington","OTHER",1,{"id":42,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100608382","NCT07200830","Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial","Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and\u002For cytological confirmation of prostate adenocarcinoma\n* PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET\u002FCT scan (either gallium Ga 68 gozetotide \\[68Ga-PSMA-11\\], fluorine F 18 piflufolastat \\[18F- DCFPyl\\], or fluorine F 18 flotufolastat gallium \\[18F-rhPSMA-7.3\\]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease\n* PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng\u002FmL\n* PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:\n\n  * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions\n  * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 \\[PCWG3\\] criteria, Scher et al 2016)\n* PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n* PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone)\n\n  \\* ARPI must be stopped at least 4 weeks prior to pre-registration\n* PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration\n* PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.)\n* PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible\n* PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed\n* PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]) within 28 days prior to pre-registration is not allowed\n* PRE-REGISTRATION (STEP 0): Age ≥ 18 years\n* PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) or \\\u003C 3 x ULN in patients with Gilbert's syndrome\n* PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL\u002Fmin\u002F1.73m\\^2 using the Modification of Diet in Renal Disease (MDRD) equation\n* PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction\n* PRE-REGISTRATION (STEP 0): Patients with treated\u002Fstable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n\n  \\* Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)\n* PRE-REGISTRATION (STEP 0): Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* PRE-REGISTRATION (STEP 0): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* PRE-REGISTRATION (STEP 0): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration\n* PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy\n* PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs\n* PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration\n* PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression\n* PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish\n* REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT\n* REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +\u002F-3 days\n* REGISTRATION (STEP 1): ECOG Performance Status ≤ 2\n* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* REGISTRATION (STEP 1): Platelet count ≥ 100,000\u002Fmm\\^3\n* REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL\u002Fmin\u002F1.73m\\^2 using the Modification of Diet in Renal Disease (MDRD) equation",{"count":48,"type":20},1524,[50],"PHASE3","This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.",[53,54,27],"Metastatic Castration-Resistant Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","RECRUITING","2026-07-01",{"date":58,"type":32},"2026-07-02",{"date":60,"type":32},"2026-03-31",{"date":62,"type":20},"2034-09-09",{"name":64,"class":39},"Alliance for Clinical Trials in Oncology",102,{"id":67,"slug":4,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100587665","NCT06931340","Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial","Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)","Inclusion Criteria:\n\n* Documentation of disease:\n\n  \\* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n* Must have had evidence of metastatic disease (American Joint Committee on Cancer \\[AJCC\\] metastasis \\[M\\]1 disease) based on conventional CT\u002FMRI and\u002For bone scan. This will be defined as:\n\n  * Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR\n  * Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes \\[N\\]1, below the aortic bifurcation) will not be eligible for the study; OR\n  * Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue\u002Fvisceral lesions are measurable if the long axis diameter is ≥ 10 mm\n  * Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria\n* No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)\n* Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible\n* Prior treatment\n\n  * ADT (luteinizing hormone-releasing hormone \\[LHRH\\] agonist\u002Fantagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration\n  * No prior chemotherapy for prostate cancer\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Platelet count ≥ 100,000\u002Fmm\\^3\n* Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate transaminase \\[SGT\\]) ≤ 1.5 x upper limit of normal (ULN)\n* Calculated (Calc.) creatinine clearance \\> 30 mL\u002Fmin\n* Serum potassium ≥ 3.5 mmol\u002FL\n* Comorbid conditions\n\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n  * Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression\n  * HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n  * Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n  * Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n  * No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy)\n  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible\n  * Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) \\>= 160 mmHg or diastolic BP \\>= 100 mmHg despite medical management are not permitted to register\n  * Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register\n* Concomitant medications\n\n  * Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information\n  * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment\n  * Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information\n* Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug",{"count":73,"type":20},1260,[50],"This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.",[77,54,27],"Castration-Sensitive Prostate Carcinoma",{"date":58,"type":32},{"date":80,"type":32},"2025-12-01",{"date":82,"type":20},"2039-05-08",{"name":64,"class":39},195,{"id":86,"slug":4,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":91,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100352247","NCT03866382","Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors","A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)","Inclusion Criteria:\n\n* Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:\n\n  * One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n  * One bone lesion on bone scan (tec99 or sodium fluoride \\[NaF\\] PET\u002FCT, CT or MRI) for the bone-only cohort.\n  * Histologically confirmed diagnosis of one of the following metastatic cohorts:\n\n    * Small cell\u002F neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded\n    * Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder\u002Furethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization \\[WHO\\] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma\n    * Squamous cell carcinoma of the bladder (Cohort C) - must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)\n    * Plasmacytoid urothelial carcinoma (Cohort D) - Tumor should show predominantly \\> or equal \\~ 50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and\u002For rhabdoid features as well)\n    * Any penile cancer (Cohort E)\n    * Sarcomatoid renal cell carcinoma (Cohort F) - Tumor should be predominantly sarcomatoid \\~ 50% (including rhabdoid differentiation) is also unclassified renal cell carcinomas (RCCs): all (assuming they are high grade with metastasis) malignant angiomyolipomas are allowed\n    * Other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to (Cohort G) : Micropapillary (Tumor should show predominantly \\> or equal 50% micropapillary architecture), giant cell, lipid-rich, clear cell and nested variants (Tumor should predominantly \\> or equal 50% show these features), large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer (Only treatment-naïve primary small cell of prostate with any amount of small cell component allowed. Post-treatment small cell prostatic carcinomas are not allowed), Malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC\n\n      * Note: Translocation positive renal cell carcinoma patients are eligible. However, AREN1721 should be considered before this trial\n    * Sarcomatoid urothelial carcinoma (Cohort H) - Tumor should show predominantly \\~ 50% sarcomatoid differentiation\n    * Renal medullary carcinoma (Cohort I) - Per World Health Organization (WHO) definition, ideally confirmed with immunostains\n    * Bone-only metastatic GU tumors (non-prostate) (Cohort J) - All genitourinary histologies, except prostate are eligible\n    * Renal Collecting Duct Carcinoma (Cohort K) - Per WHO definition (medullary involvement, predominant tubular morphology, desmoplastic stromal reaction, high grade cytology, infiltrative growth pattern, and absence of other renal cell carcinoma subtype or urothelial carcinoma)\n    * Urethra carcinoma (Cohort L) - May be of any histology but if urothelial carcinoma then must be isolated to the urethra and not have metachronous or synchronous urothelial carcinoma of the bladder\n  * H\\&E slides from diagnostic tumor tissue for retrospective central pathology review\n* Patients may have received up to 2 systemic anti-cancer treatments or be treatment naive. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin-eligible)\n* Age \\>= 18 years\n* Patients must be able to swallow oral formulation of the tablets\n* Karnofsky performance status \\>= 80%\n* Absolute neutrophil count (ANC) \\>= 1,000\u002FmcL\n* Platelet count \\>= 75,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN). For subjects with known Gilbert's disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =\\\u003C 3.0 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3.0 x institutional upper limit of normal (ULN) (or =\\\u003C 5 x ULN for patients with liver metastases or Gilbert's disease)\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR creatinine clearance \\>= 40 mL\u002Fmin\u002F1.73 m\\^2 (calculated using the Chronic Kidney Disease Epidemiology \\[CKD-EPI\\] equation or Cockcroft-Gault formula) for patients with creatinine levels above institutional normal\n* Hemoglobin \\>= 9 g\u002FdL (transfusion of packed red blood cells \\[PRBCs\\] allowed)\n* Serum albumin \\>= 3.2 g\u002FdL\n* Lipase and amylase =\\\u003C 2.0 x ULN and no radiologic (on baseline anatomical imaging) or clinical evidence of pancreatitis\n* Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1\u002FPD-L1\u002FCTLA-4 (sequentially or in combination) are also not allowed\n* No prior treatment with any therapy on the PD-1\u002FPD-L1 axis or anti- CTLA-4\u002FCTLA-4 inhibitors with the exception of patients with \"urothelial carcinoma\" histology (cohorts D, H, J, L)\n* Human immunodeficiency virus (HIV)-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART), no clinically significant drug-drug interactions are anticipated with the current HAART regimen, CD4 counts are greater than 350 and viral load is undetectable\n* Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication only and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies etc. are eligible but should be considered for rheumatologic evaluation for the presence of target organ involvement and potential need for systemic treatment\n* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones or medications (e.g. thyroiditis managed with propylthiouracil \\[PTU\\] or methimazole) including physiologic oral corticosteroids are eligible\n* Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, and gastrointestinal (GI) obstruction, within 12 months are not eligible\n* Women of childbearing potential must have a negative pregnancy test =\\\u003C 7 days prior to registration\n\n  * Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea \\>= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason\n* Pregnant women may not participate in this study because with cabozantinib, nivolumab, and ipilimumab have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cabozantinib, nivolumab, and ipilimumab, breastfeeding should be discontinued if the mother is treated with these agents\n* The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment\n* The patient has received no radiation therapy:\n\n  * To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy\n  * To brain metastasis within 3 weeks for whole-brain radiotherapy (WBXRT), and 2 weeks for stereotactic body radiation therapy (SBRT) before the first dose of study treatment\n  * To the abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy\n  * To any other site(s) within 2 weeks before the first dose of study treatment\n* The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment\n* The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment\n* The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate\n* The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment\n* The patient must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =\\\u003C grade 1 from toxicity due to all prior therapies except alopecia, neuropathy and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae\n* The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility\n* No concomitant treatment with warfarin. Aspirin (up to 325 mg\u002Fday), thrombin or factor Xa inhibitors, low-dose warfarin (=\\\u003C 1 mg\u002Fday), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted\n* No chronic concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort) or strong CYP3A4 inhibitors\n\n  * Because the lists of these agents are constantly changing, it is important to regularly consult medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* The patient has not experienced any of the following:\n\n  * Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\n  * Hemoptysis of \\>= 0.5 teaspoon (2.5 mL) of red blood per day within 1 months before the first dose of study treatment\n  * Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\n* The patient has no tumor invading any major blood vessels\n* The patient has no evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. Patients with rectal tumor masses are not eligible\n* The patient has no uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders including:\n\n    * Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening.\n    * Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic, or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\n    * The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 28 days before randomization. Note: if initial QTcF is found to be \\> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =\\\u003C 500 ms, the subject meets eligibility in this regard\n    * Any history of congenital long QT syndrome\n    * Any of the following within 6 months before registration of study treatment:\n\n      * Unstable angina pectoris\n      * Clinically-significant cardiac arrhythmias (patients with atrial fibrillation are eligible)\n      * Stroke (including transient ischemic attack \\[TIA\\], or other ischemic event)\n      * Myocardial infarction\n      * Cardiomyopathy\n  * No significant gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\n\n    * Any of the following that have not resolved within 28 days before the first dose of study treatment:\n\n      * Active peptic ulcer disease\n      * Acute diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome\n    * None of the following within 2 years before the first dose of study treatment:\n\n      * Abdominal fistula or genitourinary fistula\n      * Gastrointestinal perforation\n      * Bowel obstruction or gastric outlet obstruction\n      * Intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 2 years before the first dose of study treatment\n  * Disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement are not eligible\n  * No other clinically significant disorders such as:\n\n    * Severe active infection requiring IV systemic treatment within 14 days before the first dose of study treatment\n    * Serious non-healing wound\u002Fulcer\u002Fbone fracture within 28 days before the first dose of study treatment\n    * History of organ or allogeneic stem cell transplant\n    * Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated thyroid-stimulating hormone \\[TSH\\], thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)\n  * No history of major surgery as follows:\n\n    * Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post-surgery\n    * Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement\n    * Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery\n* No history of severe hypersensitivity reaction to any monoclonal antibody\n* No evidence of active malignancy, requiring systemic treatment within 2 years of registration\n* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study\n* No positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. If HBV sAG is positive, subsequent ribonucleic acid (RNA) polymerase chain reaction (PCR) must be negative\n* No patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include, but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease","ALL",{"count":93,"type":20},314,[23],"This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.",[97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,27,139,140],"Bladder Adenocarcinoma","Bladder Clear Cell Adenocarcinoma","Bladder Mixed Adenocarcinoma","Bladder Neuroendocrine Carcinoma","Bladder Small Cell Neuroendocrine Carcinoma","Bladder Squamous Cell Carcinoma","Chromophobe Renal Cell Carcinoma","Collecting Duct Carcinoma","Invasive Bladder Giant Cell Urothelial Carcinoma","Invasive Bladder Lymphoepithelioma-Like Carcinoma","Invasive Bladder Nested Urothelial Carcinoma","Invasive Bladder Plasmacytoid Urothelial Carcinoma","Invasive Bladder Sarcomatoid Urothelial Carcinoma","Invasive Bladder Urothelial Carcinoma","Kidney Medullary Carcinoma","Large Cell Neuroendocrine Carcinoma","Malignant Testicular Leydig Cell Tumor","Malignant Testicular Sertoli Cell Tumor","Metastatic Bladder Carcinoma","Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma","Metastatic Bladder Giant Cell Urothelial Carcinoma","Metastatic Bladder Large Cell Neuroendocrine Carcinoma","Metastatic Bladder Lipid-Rich Urothelial Carcinoma","Metastatic Bladder Micropapillary Urothelial Carcinoma","Metastatic Bladder Plasmacytoid Urothelial Carcinoma","Metastatic Bladder Sarcomatoid Urothelial Carcinoma","Metastatic Bladder Small Cell Neuroendocrine Carcinoma","Metastatic Bladder Squamous Cell Carcinoma","Metastatic Chromophobe Renal Cell Carcinoma","Metastatic Kidney Medullary Carcinoma","Metastatic Malignant Genitourinary System Neoplasm","Metastatic Papillary Renal Cell Carcinoma","Metastatic Penile Carcinoma","Metastatic Prostate Small Cell Neuroendocrine Carcinoma","Metastatic Sarcomatoid Renal Cell Carcinoma","Metastatic Urethral Carcinoma","Papillary Renal Cell Carcinoma","Sarcomatoid Renal Cell Carcinoma","Stage IV Bladder Cancer AJCC v8","Stage IV Penile Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Urethral Cancer AJCC v8","Urachal Adenocarcinoma","Urethral Clear Cell Adenocarcinoma",{"date":58,"type":32},{"date":143,"type":32},"2019-05-13",{"date":145,"type":20},"2027-02-28",{"name":147,"class":148},"National Cancer Institute (NCI)","NIH",581,{"id":151,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":40},"100534231","NCT06236139","Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer","Phase 1\u002F2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC","Inclusion Criteria:\n\n* Tissue confirmation of prostate adenocarcinoma\n* Measurable disease by RECIST 1.1 criteria or bone only metastases with measurable PSA ( ≥ 1 ng\u002FmL)\n* Must have progressed (at least 2 rising PSA levels with at least a 1-week interval and a minimum PSA of 1.0 ng\u002FmL, progression per RECIST 1.1, or 2 or more new bone lesions by bone scan), after becoming castration-resistant\n* Have received the following for metastatic prostate cancer:\n\n  * At least two lines of treatment\n  * At least two Food and Drug Administration (FDA)-approved therapies with at least one being a second generation androgen receptor signaling inhibitor (e.g., abiraterone, darolutamide, apalutamide, or enzalutamide)\n  * All available targeted therapies for which they are eligible in the metastatic setting (e.g., PARP inhibitors for BRCA 1\u002F2 and immune checkpoint inhibitor for MSI-H or TMB-H ≥ 10 mut\u002FMb)\n* Castrate levels of testosterone (\\\u003C 50 ng\u002FdL) with or without the use of androgen deprivation therapy\n* 18 years or older at the time of enrollment\n* Capable of understanding and providing a written informed consent\n* Fertile male participants and their female partners must be willing to use an effective contraceptive method before, during, and for at least 4 months after the STEAP1 CART cell infusion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants will be permitted to receive radiation therapy for palliative purposes throughout the study period, except during the 2-week period prior to undergoing leukapheresis\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \\> 50 mL\u002Fmin as calculated using the Cockcroft-Gault formula and not dialysis dependent\n* Total bilirubin ≤ 1.5 x ULN. Participants with suspected Gilbert syndrome may be included if Total bilirubin (Bili) \\> 3 mg\u002FdL but no other evidence of hepatic dysfunction\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN\n* ≤ grade 1 dyspnea and oxygen saturation (SaO2) ≥ 92% on ambient air\n* If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in 1 second (FEVI) \\>= 50% of predicted and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) of \\>= 40% of predicted will be eligible\n* Participants \\>= 60 years of age are required to have left ventricular ejection fraction (LVEF) evaluation performed within 1 year prior to lymphodepletion chemotherapy. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be \\>= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n* Absolute neutrophil count (ANC) \\> 1500 cells\u002F mm\\^3\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelets \\> 100,000 per mm\\^3\n\nExclusion Criteria:\n\n* Expecting to conceive or father children for the duration of the trial through 4 months after T cell infusion\n* Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by principal investigator (PI)\n* Corticosteroid therapy at a dose equivalent of \\>15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable\n* Concurrent use of other investigational anti-cancer agents except for androgen deprivation therapy\n* Active uncontrolled infection: human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \\> 500 cells\u002Fmm\\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication\n* Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit compliance with study requirements\n* Untreated brain metastases: Participants with small asymptomatic brain metastases ( \\\u003C 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of PI, so long as all other eligibility criteria are met\n* Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of \\> 15 mg prednisone (or equivalent) per day, unless otherwise approved by PI\n* Significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, unless approved by PI. Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* Known allergic reactions to any of the components of study treatments",{"count":157,"type":20},48,[159,23],"PHASE1","This phase I\u002FII trial tests the safety and effectiveness of cell therapy (STEAP1 CART) with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production (castration-resistant) and that has spread from where it first started (the prostate) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer deaths in men. Localized prostate cancer is often curable and even metastatic disease may respond to treatment for a few years. Despite multiple therapies, including hormone therapy and chemotherapy, metastatic castration-resistant prostate cancer (mCRPC) remains an incurable disease. Recently, adoptive cellular immunotherapies have been developed to transfer immunogenic cells to the patient to produce an anti-tumor response. Chimeric antigen receptor T (CART)-cell therapy is a type of treatment in which a patient's T-cells (a type of immune cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Prostate stem cell antigen and prostate specific membrane antigen CAR T cell therapies have been shown to be safe and effective, but objective tumor responses remain rare. STEAP1 is an antigen that promotes cancer growth and spread and is found to be broadly expressed in mCRPC tissues. STEAP1 CART is CAR T cells that have been engineered with a STEAP1 antigen to better target prostate tumor cells. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving STEAP1 CART with enzalutamide may kill more tumor cells in patients with mCRPC.",[53,54,27],"2026-06-24",{"date":164,"type":32},"2026-06-26",{"date":166,"type":32},"2024-11-26",{"date":168,"type":20},"2027-03-30",{"name":170,"class":39},"Fred Hutchinson Cancer Center",{"id":172,"slug":4,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100492386","NCT05691465","Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells","A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer With Neuroendocrine Differentiation","Inclusion Criteria:\n\n* PRE-REGISTRATION ELIGIBILITY\n* Patients must have metastatic prostate cancer with neuroendocrine differentiation, as determined by at least one of the following:\n\n  * Histologically confirmed small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy. Neuroendocrine prostate cancer includes mixed small cell with adenocarcinoma histology, as well as small or large cells with positive neuroendocrine markers (e.g., chromogranin or synaptophysin)\n  * Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the following 3: PTEN, TP53, or RB loss)\n  * Progression of visceral metastases in the absence of PSA progression\n  * Serum chromogranin A \\> 5x normal limit, or neuron-specific enolase \\> 2x normal NOTE: Both patients who have had prior cytotoxic chemotherapy and patients who have never had cytotoxic chemotherapy for prostate cancer will be allowed\n* Age \\>= 18 years. Prostate cancer is typically a disease of older men, with the average age at diagnosis being 65 years. Consequently, because the research topic is not relevant to children, no children will be included in this study. There is no upper limit to the age of participants eligible for this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 8 g\u002FdL, prior to each dose of lutetium lu 177 dotatate\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Creatinine Cockcroft calculated creatinine clearance of \\>= 40 mL\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients should be New York Heart Association Functional Classification of class 2B or better\n* Current disease progression according to PCWG3 criteria\n* Ongoing use of luteinizing hormone-releasing hormone (LHRH) agonists\u002Fantagonists will be required (unless prior bilateral orchiectomy or pure neuroendocrine carcinoma histology) to maintain testosterone at castrate levels. Patients with a pure neuroendocrine carcinoma histology do not need to be undergoing LHRH agonist\u002Fantagonist therapy\n* No concurrent use of other anti-cancer therapies\n* Pregnancy Precaution: The effects of lutetium lu 177 dotatate on the developing human fetus are unknown. For this reason and because radionuclides are known to be teratogenic, male participants and their female partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lutetium lu 177 dotatate administration. Patients must not donate sperm during the study and for 3 months after the last study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n* Patients will undergo a Gallium 68 Dotatate PET scan after enrollment. The Gallium 68 Dotatate PET must be positive to proceed with lutetium Lu 177 dotatate therapy. A positive scan will be defined as at least one lesion with an maximum standardized uptake value (SUVmax) \\> the average standardized uptake value (SUV) of normal liver. The positive lesion(s) can be in any location (bone metastases or visceral metastases). Patients with only bone metastases will be allowed\n* REGISTRATION ELIGIBILITY: The gallium 68 dotatate PET is positive. A positive scan will be defined as at least one lesion with an maximum standardized uptake value (SUVmax) \\> the average SUV of normal liver. The positive lesion(s) can be in any location (bone metastases or visceral metastases). Patients with only bone metastases will be allowed.\n* REGISTRATION ELIGIBILITY: Absolute neutrophil count ≥ 1,500\u002FmcL\n* REGISTRATION ELIGIBILITY: Platelets ≥ 100,000\u002FmcL\n* REGISTRATION ELIGIBILITY: Hemoglobin ≥ 8 g\u002FdL, prior to each dose of lutetium Lu 177 dotatate\n* REGISTRATION ELIGIBILITY: Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)\n* REGISTRATION ELIGIBILITY: AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n* REGISTRATION ELIGIBILITY: Creatinine Cockcroft calculated creatinine clearance of ≥ 40 mL\u002Fmin OR\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lutetium Lu 177 dotatate\n* As per the Food and Drug Administration (FDA) package insert for Lutetium Lu 177 dotatate, use of long-acting somatostatin analogs (e.g., long-acting octreotide) is prohibited within 4 weeks prior to initiating Lutetium Lu 177 dotatate and during treatment. Use of short-acting somatostatin analogs is prohibited within 24 hours prior to initiating Lutetium Lu 177 dotatate and during treatment. Long-acting somatostatin analogs or short-acting somatostatin analogs will be allowed if the patient has a history of carcinoid syndrome and requires long-acting or short-acting somatostatin analogs for the control of his functional syndrome\n* Patients with uncontrolled intercurrent illness\n* Any of the following within 6 months before starting treatment: stroke, myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV\n* Uncontrolled hypertension as indicated by a systolic blood pressure \\>= 160 mmHg or diastolic blood pressure \\>= 100 mmHg at screening",{"count":178,"type":20},35,[23],"This phase II trial studies how well lutetium Lu 177 dotatate works in treating patients with prostate cancer with neuroendocrine differentiation that has spread to other places in the body (metastatic). Neuroendocrine differentiation refers to cells that have traits of both hormone-producing endocrine cells and nerve cells. These cells release hormones into the blood in response to a signal from the nervous system. Hormones are biological substances that circulate through the bloodstream to control the activity of other organs or cells in the body. Lutetium Lu 177-dotatate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Treatment with Lutetium Lu 177 dotatate may shrink the tumor in a way that can be measured in patients with metastatic prostate cancer with neuroendocrine differentiation.",[182,183,130,27],"Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation","Metastatic Prostate Neuroendocrine Carcinoma",{"date":185,"type":32},"2026-06-25",{"date":187,"type":32},"2023-12-27",{"date":189,"type":20},"2026-11-02",{"name":147,"class":148},13,{"id":193,"slug":4,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":216},"100394987","NCT04423211","Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)","Inclusion Criteria:\n\n* STEP 0: REGISTRATION ELIGIBILITY CRITERIA\n* Patient must be male and \\>= 18 years of age.\n* Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma\n* Patient must have biochemical recurrence (BCR) after RP, defined as follows:\n\n  * If time to BCR, defined as time to first detectable PSA ( \\> lower limit of normal for assay used) after RP, is \\\u003C 12 months, a minimum PSA level of \\>= 0.2 ng\u002FmL and a confirmatory reading of \\>= 0.2 ng\u002FmL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng\u002FmL are eligible)\n  * If time to BCR, defined as time to first detectable PSA (\\> lower limit of normal for assay used) after RP, is \\>= 12 months, a minimum absolute PSA of 0.5 ng\u002FmL is required\n  * If the patient has a detectable PSA (\\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement\n* Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen\u002Fpelvis or MRI abdomen\u002Fpelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET\u002FCT or PET\u002FMR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT\u002FMRI for soft tissue lesions and\u002For a bone scan for osseous lesions\n\n  * Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration\n* Extra-pelvic metastases is defined as any osseous metastases and\u002For any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET\u002FCT or PET\u002FMR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration\n* Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET\u002FCT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.\n* Patient must not be enrolled in another therapeutic clinical trial\n* Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery\n* Patients undergoing a PET\u002FMR must meet local institutional safety guidelines for MRI\n* Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration\n* Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy\n* Hemoglobin (Hgb) \\>= 9.0 g\u002FdL (independent of transfusion and\u002For growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)\n* Leukocytes \\>= 3,000\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Absolute neutrophil count \\>= 1,500\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Platelets \\>= 100,000\u002FmcL (obtained within 8 weeks prior to Step 0 registration)\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, must have a direct bilirubin of \\\u003C 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)\n* Creatine \\\u003C 1.5 x instituional ULN (or measured creatinine clearance \\> 30 mL\u002Fmin)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)\n* Patient must not have completed a course of prior pelvic radiation therapy for any reason\n* Patient must agree not to father children while on study\n* Patient must be English or Spanish speaking to be eligible for the QOL component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms\n* STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA\n* Patient must have completed a baseline SOC PET\u002FCT or PET\u002FMR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration\n* For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)\n* For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields \\[prostate bed +\u002F- typical whole pelvis\\]), the number of extra-pelvic lesions must be known (1 - 5 or \\> 5 extra-pelvic lesions)",{"count":199,"type":20},804,[50],"This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \\[PSA\\] after surgical removal of the prostate cancer).\n\nA second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.\n\nDiagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.",[203,204,205,27],"Biochemically Recurrent Prostate Carcinoma","Metastatic Prostate Carcinoma","Prostate Adenocarcinoma","2026-06-16",{"date":208,"type":32},"2026-06-18",{"date":210,"type":32},"2020-10-08",{"date":212,"type":20},"2032-12-31",{"name":214,"class":215},"ECOG-ACRIN Cancer Research Group","NETWORK",342,{"id":218,"slug":4,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":242,"leadSponsor":244,"locationsCount":40},"100641941","NCT07650240","Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial","A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer","SPARKLE","Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Signed informed consent must be obtained prior to participation in the study\n* Histologically confirmed adenocarcinoma of the prostate\n* Prior treatment with radical prostatectomy or radiation therapy for localized disease is required\n* Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:\n\n  * The last treatment \\> 12 months from enrollment on the trial\n  * The duration of treatment is less than 3 months and no evidence of disease progression on treatment\n* Disease detected on PSMA PET\u002FCT scan \\[PSMA-avid low volume metastasis (LVM)\\]. Patients with standardized uptake value maximum (SUVMax) lesion\u002Fliver \\>1 \\[molecular imaging PSMA (miPSMA) score of 2\\] or lesion\u002Fparotid \\> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET\u002FCT image acquisition and reconstruction\n* Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET\u002FCT is defined as:\n\n  * =\\\u003C 10 total metastatic spots\n\n    * Lymph nodes with short axis of =\\\u003C 2.5 cm\n    * Total tumor volume (TTV) \\\u003C 200 mL\n  * =\\\u003C 4 bone metastases\n  * No brain or liver metastases\n* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3\n* Serum bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) =\\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \\>= 50 mL\u002Fmin\u002F1.73m\\^2\n* Able to start therapy within 28 days of screening\n* Expected life expectancy \\> 6 months\n\nExclusion Criteria:\n\n* PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET\u002FCT imaging\n* PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \\>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \\>= 1 cm, and bone metastases with a measurable soft tissue component \\>= 1 cm\n* Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)\n* Patient with spinal metastatic disease-causing cord compression\n* Patient with prior disease progression on ADT \\[castration resistance prostate cancer (CRPC)\\]\n* Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial\n* Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment\n* Patients with severe \\[Common Terminology Criteria for Adverse Events (CTCAE) grade \\> 2\\] xerostomia\n* Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice\n* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible\n* Estimated life expectancy \\\u003C 6 months\n* Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study\n\n  * Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617",{"count":225,"type":20},202,[23],"This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.",[229,27,230,231,232,205,233,234,235,54,236,237],"Recurrent Prostate Adenocarcinoma","Castration-Sensitive Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Prostate Cancer","Adenocarcinoma of the Prostate","Localized Prostate Carcinoma","Metastatic Prostate Cancer","Advanced Prostate Cancer","Advanced Prostate Adenocarcinoma","2026-06-15",{"date":240,"type":32},"2026-06-17",{"date":56,"type":20},{"date":243,"type":20},"2030-12-30",{"name":245,"class":39},"Mayo Clinic",{"id":247,"slug":4,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":40},"100469860","NCT05398302","Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy","Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy","Inclusion Criteria:\n\n* Volunteer patient\n* Histologically confirmed prostate cancer\n* Eligible for 177Lu-PSMA-617 under expanded access protocol (IRB# 21-5010) or as part of an approved trial\n* Based on positron emission tomography (PET)\u002Fcomputed tomography (CT) images: Evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy\n* Platelets \\> 75,000\u002Ful within 14 days prior to biopsy\n* Prothrombin time (PT) or International normalized ratio (INR) and a partial thromboplastin time (PTT) \\\u003C 1.5 times the institutional upper limit normal (ULN) within 14 days prior to biopsy\n* Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)\n\nExclusion Criteria:\n\n* Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible",{"count":253,"type":20},30,[159],"This clinical trial studies mechanisms of resistance to 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy using image-guided biopsies in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Diagnostic procedures, such as image guided biopsies, may help in learning how well 177Lu-PSMA works to kill tumor cells and allow doctors to plan better treatment.",[257,204,258,259,27],"Castration-Resistant Prostate Carcinoma","Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage IVA Prostate Cancer AJCC v8","2026-06-11",{"date":238,"type":32},{"date":263,"type":32},"2024-04-26",{"date":265,"type":20},"2027-12-31",{"name":267,"class":39},"Jonsson Comprehensive Cancer Center",{"id":269,"slug":4,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":40},"100539573","NCT06305598","Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer","Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Histologically confirmed carcinoma of the prostate\n* Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist)\n* Documented castrate level of blood testosterone (\\\u003C 50 ng\u002FdL)\n* Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) (by prostate specific antigen \\[PSA\\] criteria or radiographically)\n* Have biopsiable disease (a fresh biopsy is not required at baseline if adequate archival tissue is available)\n* Absolute neutrophil count: ≥1,200\u002FµL\n* Platelets: ≥ 100,000\u002FµL\n* Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]): ≤ 3 × institutional ULN\n* Creatinine clearance (CrCl) \\> 50 mL\u002Fmin (Cockcroft-Gault equation)\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* Greater than 5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤ 1 cm in diameter is permitted)\n* Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)\n* Active uncontrolled infection, including known history of acquired immunodeficiency syndrome (AIDS) or hepatitis B or C\n* Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule\n* Prior history of a thromboembolic event within the last 12 months and not currently on systemic anticoagulation\n* Hematocrit \\> 50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure (per Endocrine Society Clinical Practice Guidelines)\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study\n* Known allergy to testosterone cypionate or any of its excipients\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":275,"type":20},14,[159],"This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.",[257,204,27],"2026-06-09",{"date":281,"type":32},"2026-06-10",{"date":283,"type":32},"2024-12-19",{"date":285,"type":20},"2029-12-15",{"name":287,"class":39},"Roswell Park Cancer Institute",{"id":289,"slug":4,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":40},"100452216","NCT05168618","Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer","AtezoCab: A Phase II Study of Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Non-Measurable Disease","AtezoCab","Inclusion Criteria:\n\n* Male subject aged \\>= 18 years\n* Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology\n* Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state\n* Patient must have non-measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria. Non-measurable disease can be bone lesions and\u002For extraskeletal disease\n* Disease progression on or after at least one prior novel hormonal therapy (NHT) (defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, darolutamide)\n* Eastern Cooperative Oncology Group (ECOG) performance Status =\\\u003C 2\n* Effective castration with serum testosterone levels =\\\u003C 0.5 ng\u002FmL (=\\\u003C1.7 nmol\u002FL)\n* Tumor tissue available (archival or recent tumor biopsy). If no tumor tissue is available, patients can be enrolled after approval from Principal Investigator.\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 without granulocyte colony-stimulating factor support\n* White blood cell count \\>= 2500\u002FuL\n* Lymphocyte count \\>= 0.5 x 10\\^9\u002FL (500\u002FuL)\n* Platelet count \\>= 100,000\u002Fmm\\^3 without transfusion in the 2 weeks prior to cycle 1 day 1 (C1D1)\n* Hemoglobin \\>= 9 g\u002FdL\n* Serum albumin \\>= 2.5 g\u002Fdl\n* For patients not receiving therapeutic anticoagulation: prothrombin time (PT)\u002FInternational normalized ratio (INR) or partial thromboplastin time (PTT) test \\\u003C 1.5 x institutional upper limit of normal (ULN). For patients receiving therapeutic anticoagulation: stable anticoagulant regimen as determined by Investigator\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN). For subjects with Gilbert's disease =\\\u003C 3 x institutional ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 × institutional ULN\n\n  * Subjects with liver metastases will be allowed to enroll with AST and ALT levels =\\\u003C 5 x institutional ULN\n* Alkaline phosphatase (ALP) =\\\u003C 3 × institutional ULN. Patients with documented liver or bone metastases: ALP =\\\u003C 5 x institutional ULN\n* Serum creatinine =\\\u003C 1.5 x institutional ULN or calculated creatinine clearance \\>= 40 mL\u002Fmin by Cockcroft-Gault formula\n* Urine protein\u002Fcreatinine ration (UPCR) =\\\u003C 1mg\u002Fmg (=\\\u003C 113.2 mg\u002Fmmol), or 24-hour (h) urine protein =\\\u003C 1 g\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of study treatment\n* Male subjects must agree to use a condom during intercourse for the duration of study therapy\n* Recovery to baseline or =\\\u003C grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator and\u002For stable on supportive therapy\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\n* Capable of understanding and complying with the protocol requirements\n\nExclusion Criteria:\n\n* Prior chemotherapy in the metastatic castration refractory prostate cancer setting is not allowed (taxane-based in metastatic castration-sensitive disease is allowed)\n* Prior treatment with cabozantinib, CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-a, anti-PD1 and anti-PD-L1 therapeutic antibodies\n* Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Receiving other investigational agents\n* Patients with measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria\n* History of Leptomeningeal disease\n* Uncontrolled tumor-related pain\n\n  * Note: Patients requiring pain medication must be on a stable regimen at study entry\n  * Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation\n  * Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible\n* Major surgery (e.g., laparoscopic nephrectomy, gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 4 weeks before first dose of study treatment or anticipation of need for a major surgical procedure during the study. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \\[OS\\] rate \\> 90%), such as locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast\n* Known brain metastases or cranial epidural disease\n\n  * Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment after radiotherapy or at least 4 weeks prior to the first dose of study treatment after major surgery (e.g. removal or biopsy of brain metastasis) will be allowed on trial. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines), low-dose low molecular weight heparins (LMWH), or prophylactic dose of anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban.\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 30 days before first dose of any study treatment and for 5 months after the last dose of any study treatment\n* Current evidence of uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class II, III or IV, unstable angina pectoris, serious unstable cardiac arrhythmias\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before the first dose of study treatment\n\n      * Subjects with a diagnosis of incidental, sub segmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation for at least 1 week before first dose of study treatment\n    * Uncontrolled hypertension defined as persistent systolic blood pressure (BP) \\> 150 mm Hg or diastolic BP \\> 90 mm Hg despite optimal antihypertensive treatment\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    * The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction\n    * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation\n* Lesions invading or encasing any major blood vessels\n* Any active or history of known or suspected autoimmune disease as determined to be clinically significant by treating investigator's clinical judgement will be excluded , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis (see Appendix for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\n  * Controlled Type 1 diabetes mellitus who are an insulin regimen\n  * Autoimmune-related hypothyroidism who are on thyroid replacement hormone\n  * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months\n  * Conditions not expected to recur in the absence of an external trigger\n* Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained\n  * Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n  * Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Any active infection requiring systemic treatment.\n\n  * Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) or oral valacyclovir (valaciclovir) are eligible for the study\n* Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection. Note: Subjects on effective HIV antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture\n* Malabsorption syndrome\n* Uncompensated\u002Fsymptomatic hypothyroidism\n* Moderate to severe hepatic impairment (Child-Pugh B or C)\n* Requirement for hemodialysis or peritoneal dialysis\n* History of solid organ or allogenic stem cell transplant\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n  * Note: Patients with indwelling catheters (e.g., PleurX) are allowed\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment. Furthermore, subjects with a history of additional risk factors for Torsades de pointes (e.g., long QT syndrome) are also excluded.\n\n  * Note: If a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n* Inability to swallow tablets or unwillingness or inability to receive IV administration\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3). Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study\n* Subjects taking prohibited medications as described in Section 6. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment",{"count":5,"type":20},[23],"This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.",[257,54,299,259,27],"Stage IV Prostate Cancer AJCC v8","2026-06-04",{"date":302,"type":32},"2026-06-05",{"date":304,"type":32},"2022-03-29",{"date":306,"type":20},"2027-01",{"name":308,"class":39},"University of Utah",{"id":310,"slug":4,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":91,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100564730","NCT06632977","Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial","PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)","PREDICT","Inclusion Criteria:\n\n* PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required.\n* PRE-REGISTRATION: Measurable disease and\u002For non-measurable metastatic disease per RECIST version 1.1.\n* PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.\n* PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular\u002FDNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA\u002FRNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.\n* PRE-REGISTRATION: Age ≥ 18 years.\n* REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \\< 50 ng\u002FdL AND one or more of the following criteria (choose all the apply):\n\n  * PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng\u002FmL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.\n  * Radiographic progression per RECIST 1.1 criteria for soft tissue lesions\n  * Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.\n* REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).\n* REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1\u002F2 mutations must have received a prior PARPi.\n* REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \\> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:\n\n  * Chemotherapy-induced neuropathy\n  * Fatigue\n  * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism\u002Fhyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)\n* REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.\n* REGISTRATION: No major surgery within 4 weeks of registration.\n* REGISTRATION: No prior treatment with EZH inhibitors.\n* REGISTRATION: Prior treatment with cabazitaxel + carboplatin.\n* REGISTRATION: None of the following conditions:\n\n  * Current use of moderate or strong cytochrome P450 (CYP)3A inducers.\n  * Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.\n  * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n  \\* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * Imminent or established spinal cord compression based on clinical and\u002For imaging findings.\n  * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.\n  * Significant cardiovascular defined as:\n  * Myocardial infarction within 6 months prior to enrollment.\n  * Uncontrolled angina pectoris within 6 months prior to enrollment.\n  * New York Heart Association Class 3 or 4 congestive heart failure.\n  * Corrected QT interval calculated by the Fridericia\\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents\u002Fconditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.\n  * Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\> 100 mmHg).\n  * Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.\n  * Moderate to severe hepatic impairment (Child-Pugh Class C)\n* REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.\n* REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.\n* REGISTRATION: No platelet transfusions within 2 weeks of registration.\n* REGISTRATION: No bleeding diathesis.\n* REGISTRATION: White blood cell count (WBC) ≥ 2,500\u002FmcL.\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL.\n* REGISTRATION: Hemoglobin ≥ 9 g\u002FdL.\n* REGISTRATION: Platelet count ≥ 100,000\u002FmcL.\n* REGISTRATION: Creatinine clearance ≥ 30 mL\u002Fmin as defined by Cockcroft-Gault equation.\n* REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal \\[ULN\\] for subjects with documented Gilbert\\'s disease).\n* REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.\n* REGISTRATION: Albumin ≥ 2.8 g\u002FdL.\n* REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration\u002Frandomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.\n* RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \\< 50 ng\u002FdL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT\u002FMRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).\n* RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \\> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:\n\n  * Chemotherapy-induced neuropathy\n  * Fatigue\n  * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism\u002Fhyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).\n* RE-REGISTRATION: None of the following conditions:\n\n  * Imminent or established spinal cord compression based on clinical and\u002For imaging findings.\n  * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.\n  * Corrected QT interval calculated by the Fridericia\\'s formula (QTcF) \\< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.\n  * Significant cardiovascular defined as:\n  * Myocardial infarction within 6 months prior to enrollment.\n  * Uncontrolled angina pectoris within 6 months prior to enrollment.\n  * New York Heart Association Class 3 or 4 congestive heart failure.\n  * Uncontrolled hypertension (resting systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n* RE-REGISTRATION: ECOG Performance Status 0-2.\n* RE-REGISTRATION: No GCSF within 2 weeks of registration.\n* RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.\n* RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.\n* RE-REGISTRATION: WBC ≥ 2,500\u002FmcL.\n* RE-REGISTRATION: ANC ≥ 1,500\u002FmcL.\n* RE-REGISTRATION: Hemoglobin ≥ 9 g\u002FdL (transfusions permitted).\n* RE-REGISTRATION: Platelet count ≥ 100,000\u002FmcL.\n* RE-REGISTRATION: Creatinine clearance ≥ 30 mL\u002Fmin as defined by Cockcroft-Gault equation.\n* RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\\'s disease).\n* RE-REGISTRATION: AST and ALT ≤ 3 x ULN.\n* RE-REGISTRATION: Albumin ≥ 2.8 g\u002FdL.\n* RE-REGISTRATION: QT Interval (QTcF) \\< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).\n* RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration\u002Frandomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.\n\nExclusion Criteria:\n\n\\-",{"count":317,"type":20},474,[23],"This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1\u002FEZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing",[257,27],"2026-06-01",{"date":323,"type":32},"2026-06-02",{"date":325,"type":32},"2025-02-06",{"date":327,"type":20},"2034-10-11",{"name":64,"class":39},107,{"id":331,"slug":4,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":91,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":4},"100591576","NCT06982222","Testing the Safety of the Anti-cancer Drug, Sn-117m-DTPA, for Advanced Cancers That Have Spread to Bones","A First-in-Human Dose-Finding Phase I Study of Bone-targeted High Specific Activity Stannic-117m Pentatate (Sn-117m-DTPA) in Solid Tumors With Skeletal Metastases","Inclusion Criteria:\n\n* Histologically documented prostate, breast, or non-small cell lung cancer (NSCLC)\n* Metastatic disease in bone only (patients with visceral disease, cutaneous disease or malignant lymph nodes \\> 3 cm in largest diameter are not eligible)\n* Documented disease progression (1 or more new bone lesion or enlargement of existing bone lesion, identified by Tc-99m bone scintigraphy or CT scan, magnetic resonance imaging \\[MRI\\], fludeoxyglucose F-18 \\[FDG\\] PET CT scan or PSMA PET CT scan)\n* Must have progression on at least one line of standard of care systemic therapy. There are no maximum number of prior therapies\n* Patients with prostate cancer\n\n  * Patients with prostate adenocarcinoma, their disease must be characterized as: must have prior bilateral orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n  * Serum PSA progression, defined as two consecutive increases in PSA over a previous reference value, each measurement at least one week apart or, PSA progression ≥ 25% after 12 weeks of current standard of care (SOC) therapy (Scher et al., 2016)\n  * Patients must have a baseline positive PSMA-PET scan. Patients must have progressed on at least one line of hormone therapy: Androgen receptor signaling inhibitors (ARSIs) therapy such as enzalutamide, apalutamide, darolutamide, or androgen synthesis blockers (abiraterone acetate). There are no minimum number of prior hormone therapies\n  * Progression after chemotherapy (docetaxel or cabazitaxel) in patients who were chemotherapy candidates is allowed. However, prior chemotherapy is not required\n  * Progression after a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical therapy (for example: lutetium-177 vipivotide tetraxetan \\[Pluvicto\\]) is allowed but not required\n  * Allowed to have received one prior cytotoxic chemotherapy treatment and one radiopharmaceutical therapy treatment OR no more than two cytotoxic chemotherapy treatments (for patients who have not received a prior radiopharmaceutical therapy treatment)\n* Patients with breast cancer\n\n  * Patients with any estrogen receptor (ER)\u002Fprogesterone receptor (PR)\u002Fhuman epidermal growth factor receptor 2 (HER2) receptor status are eligible\n  * Patients with hormone-receptor positive disease should have progressed on at least one or more prior line(s) of SOC anti-estrogen therapy and a cyclin-dependent kinase (CDK)4\u002F6 inhibitor (except if patient had a contraindication or intolerable toxicity with the use of these agents)\n  * Patients with HER2 positive disease should have progressed on at least one or more line(s) of SOC anti-HER2 therapy.\n  * Patients with triple negative disease should have progressed on at least one more line(s) of SOC chemotherapy\n  * Previous radiation and chemotherapy are allowed\n* Patients with non-small cell lung cancer (NSCLC)\n\n  * Patients with NSCLC should have progressed on at least one or more prior line(s) of SOC therapy, including chemotherapy and\u002For immunotherapy or targeted therapy if they qualify\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of Sn-117m-DTPA in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 75,000\u002FmcL\n* Hemoglobin \\> 9 g\u002FdL\n* Total bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x institutional ULN\n* Creatinine ≤ 1.7 mg\u002FdL OR glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n* Patients must be taking a bone health agent (bisphosphonates or denosumab) for at least one (1) month prior to enrollment\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* The effects of Sn-117m-DTPA on the developing human fetus are unknown. For this reason and because radionucleotides are known to be teratogenic, male participants and their female partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A woman of childbearing potential is a premenopausal female capable of becoming pregnant. Should a woman of childbearing potential become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately. Both men and women of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of Sn-117m-DTPA administration. For prostate cancer patients, androgen deprivation therapy is considered adequate contraception\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign if the patient is physically (not mentally) not capable of signing\n\nExclusion Criteria:\n\n* Patients who have not recovered from reversible adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients must not have received any investigational agents within 4 weeks or 5 half-lives, whichever is shorter, before starting study treatment, nor be scheduled to receive one during the planned treatment period\n* Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sn-117m-DTPA\n* Patients must not have imminent or established spinal cord compression, pathological fracture in weight bearing bones, or bone lesion with soft tissue component unless treated as appropriate with radiation and\u002For surgery before starting on this study\n* Patients must not have received prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223 dichloride (Xofigo) for the treatment of bony metastases. Prior systemic radiopharmaceutical therapy with lutetium Lu 177 vipivotide tetraxetan (Pluvicto) is permitted, but last treatment must be at least six weeks prior to starting study treatment due to the concern of bone marrow suppression\n* Patients must not have unmanageable urinary incontinence\n* Pregnant women are excluded from this study because Sn-117m-DTPA is a radionucleotide with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Sn-117m-DTPA, breastfeeding should be discontinued if the mother is treated with Sn-117m-DTPA",{"count":337,"type":20},24,[159],"This phase I trial tests the safety, side effects and best dose of tin (Sn)-177m-diethylenetriaminepentaacetic acid (DTPA) and how well it works in treating prostate, breast or non-small cell lung cancer that has spread from where it first started (primary site) to the bones (bone metastases). Sn-117m-DTPA was originally tested in tumors that had spread to the bones to help reduce bone pain. The drug has been improved and is designed to send low-level radiation to tumors in the bone while being gentler on the bone marrow, where blood cells are made. Sn-117m-DTPA may be safe and tolerable, and may slow down or shrink tumors in patients with metastatic prostate, breast, or non-small cell lung cancer that has spread to the bones.",[341,342,343,344,54,345,27],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Bone","Stage IV Lung Cancer AJCC v8","2026-05-12",{"date":348,"type":32},"2026-05-13",{"date":350,"type":20},"2026-10-01",{"date":352,"type":20},"2027-02-12",{"name":147,"class":148},{"id":355,"slug":4,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100563437","NCT06616155","Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer","Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b\u002F2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration\n* Males age ≥ 18 years with progressive metastatic, castration-resistant prostate cancer, previous adenocarcinoma histology confirmation required\n* Ability to understand a written informed consent document, as determined by the study physician or designee\n* Surgical castration or continuous medical castration ≥ 8 weeks prior to screening; serum testosterone \\\u003C 50 ng\u002FdL\n* Have progressed on prior abiraterone treatment by Prostate Cancer Working Group 3 prostate specific antigen (PSA) criteria\n\n  * PSA must rise on two measurements at least 1 week apart in order to be eligible. Refer to PCWG3 for clarification.\n  * Most Recent absolute PSA must be \\> 2.0 ng\u002FmL\n* Patient meets definition of poor responder to abiraterone by one of the following:\n\n  * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting (abiraterone started within 4 months of starting continuous androgen deprivation therapy \\[ADT\\]): \\\u003C 12 months duration on abiraterone\n  * Abiraterone started in castration-resistant prostate cancer (CRPC) disease setting: \\\u003C 6 months duration on abiraterone due to progression or failure to achieve PSA50 response while on therapy\n* The patient's current or most recent treatment is ADT and abiraterone. Participants must sign consent within 30 days of discontinuing abiraterone or prior to stopping abiraterone\n* Patients must be willing to undergo metastatic tumor biopsy during screening. If no metastatic lesion is safely accessible to tumor biopsy, this requirement will not be required\n* 50% of patients must have measurable disease by RECIST 1.1 criteria\n\n  * Once 50% of total expected cohort has non-measurable disease, only patients with measurable disease by RECIST 1.1 criteria will be eligible. (Percentages with measurable disease are not relevant within dose escalation. Once dose expansion is started, those at expansion dose would be included in percentage evaluation.)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 (grade 2 ECOGs should be related to disease and thus potentially reversible)\n* A male participant must agree to use of contraception during the treatment period and for at least 90 days after the last dose of study drug. Female partners of male patients should also use contraception for 90 days after the last dose of study drug if they are of childbearing potential\n* Platelets ≥ 125,000\u002Fmm\\^3 (obtained within 28 days prior to starting study therapy) (if creatinine clearance \\[CrCl\\] is between 30-59, the platelet entry criteria is \\> 150,000\u002Fmm\\^3)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained within 28 days prior to starting study therapy)\n* Hemoglobin ≥ 11 g\u002FdL (obtained within 28 days prior to starting study therapy) No transfusions within 90 days prior to screening unless performed for acute bleeding\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (obtained within 28 days prior to starting study therapy) For patients with known liver metastasis: (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN\n* Bilirubin ≤ 1.5 the upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL (obtained within 28 days prior to starting study therapy)\n* Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (obtained within 28 days prior to starting study therapy) For creatinine clearance estimation, the Cockcroft and Gault equation should be used\n\nExclusion Criteria:\n\n* History of untreated (with radiotherapy and\u002For surgery) brain metastasis is not allowed (stable and treated metastases are allowed)\n* History of seizures or known hypersensitivity to enzalutamide, ruxolotinib or any of the excipients in the product\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with the absorption of the study medications\n* Uncontrolled hypertension as indicated by systolic blood pressure (SBP) \\> 170 mmHg or diastolic blood pressure (DBP) \\> 105 mmHg on 2 consecutive measurements at screening visit unless known to have white coat hypertension syndrome\n* Have received chemotherapy in the metastatic castration-resistant setting (docetaxel within the hormone sensitive setting is allowed)\n* Failure to recover to grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study consent\n* Current active infection with any of the following: hepatitis B, hepatitis C, active tuberculosis, latent tuberculosis. Patients with well controlled HIV are eligible however all drug interactions with HIV drug and study therapies have to be reviewed\n* History of myocardial infarction, stroke, pulmonary embolism or deep vein thrombosis within 6 months of study enrollment\n* Study physician estimates life expectancy less than 6 months or patient is unable to swallow medications\n* Patients currently taking fluconazole\n* Currently receiving supplements containing androgens or medications known to be strong inhibitors of CYP2C8, strong inducers (except enzalutamide) or strong inhibitors of CYP3A4 and substrates of CYP3A4, CYP2C9 and CYP2C19 with a narrow therapeutic window. If substitution is possible, strong inducers, inhibitors and substrates must be discontinued at least 7 days or 5 half-lives (which ever longer) prior to the first administration of enzalutamide\n* Due to risk of tuberculosis (TB) reactivation, patients deemed at high risk by treating provider (e.g., close contact with someone with active TB, history of active\u002Flatent TB) should be excluded\n* Those with underlying hepatic disease with a CHILD-PUGH class A, B or C impairment are excluded",{"count":361,"type":20},20,[159,23],"This phase I\u002FII tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and\u002For effective in treating metastatic castration-resistant prostate cancer.",[257,54,27],"2026-04-30",{"date":367,"type":32},"2026-05-05",{"date":369,"type":20},"2026-06",{"date":371,"type":20},"2030-06",{"name":373,"class":39},"University of Michigan Rogel Cancer Center",3,{"id":376,"slug":4,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":40},"100609789","NCT07219147","177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer","Pilot Study of ¹⁷⁷Lu-PSMA-617 in Combination With Sipuleucel-T in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n* Male\n* Progressive castration-resistant metastatic prostate cancer with pathologically confirmed adenocarcinoma of the prostate without small cell features\n* Patients must have either:\n\n  * Measurable disease\n\n    * For extranodal (visceral) lesions (e.g. lung, liver, etc.) to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT\n    * For lymph nodes to be considered measurable (i.e., target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT\n  * OR non-measurable disease\n\n    * All other lesions, including small lesions (longest diameter \\\u003C 20 mm with conventional techniques or \\\u003C 10 mm with spiral CT scan) and truly non-measurable lesions\n    * Lesions that are considered non-measurable include bone lesions (only). Progression on first generation ADT\n* Patients must have been on androgen deprivation therapy with a gonadotrophin releasing hormone (GnRH) analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration) for at least 3 months prior to study entry and maintain castrate levels of serum testosterone \\\u003C 50 ng\u002FdL throughout study participation unless intolerant\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (within 10 days prior to day 1 of protocol therapy)\n* White blood cell (WBC) counts \\> 2500\u002FuL (within 10 days prior to day 1 of protocol therapy)\n* Lymphocyte count ≥ 300\u002FuL (within 10 days prior to day 1 of protocol therapy)\n* Platelets ≥ 100,000\u002Fmm\\^3 (within 10 days prior to day 1 of protocol therapy)\n* Hemoglobin ≥ 9g\u002FdL (within 10 days prior to day 1 of protocol therapy)\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 10 days prior to day 1 of protocol therapy) (unless has Gilbert's disease, serum bilirubin level ≤ 3 x ULN)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 10 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (within 10 days prior to day 1 of protocol therapy)\n* Alkaline phosphatase ≤ 3 x ULN (within 10 days prior to day 1 of protocol therapy) (Patients with documented bone metastases, alkaline phosphatase \\[ALP\\] ≤ 5 x ULN)\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance of ≥ 50 mL\u002Fmin per Cockcroft-Gault formula (within 10 days prior to day 1 of protocol therapy)\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN (within 10 days prior to day 1 of protocol therapy)\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.3 x ULN (within 10 days prior to day 1 of protocol therapy)\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \\[RPR\\]) (within 10 days prior to day 1 of protocol therapy)\n\n  * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed. OR\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* For male patients with partners of childbearing potential, agreement (by patient and\u002For partner) to use highly effective form(s) of contraception or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Any approved or investigational anticancer therapy, including chemotherapy, hormonal therapy (e.g., androgen receptor \\[AR\\] antagonists, 5 alpha reductase inhibitor, estrogen), or radiotherapy, within 4 weeks prior to initiation of study treatment\n\n  * Treatment with any of the following medications or interventions within 28 days of registration:\n\n    * External beam radiation therapy or surgery\n    * Chrysanthemum morifolium\u002FGanoderma lucidum\u002FGlycyrrhiza glabra\u002FIsatis indigotica\u002FPanax pseudoginseng\u002FRabdosia rubescens\u002FScutellaria baicalensis\u002FSerona repens supplement (PC-SPES) (or PC-SPEC) or saw palmetto\n    * Systemic corticosteroids. Use of inhaled, intranasal, and topical steroids is acceptable\n    * Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate\n    * Ketoconazole\n    * 5-alpha-reductase inhibitors (e.g., finasteride \\[Proscar®\\], dutasteride \\[Avodart®\\])\n    * High dose calcitriol (1,25\\[OH\\]2 vitamin \\[Vit\\]D) (i.e., \\> 7.0 ug\u002Fweek)\n* Prior treatment with 177\\^Lu-PSMA-617 and\u002For sipuleucel-T\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\n* Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration\n* Patients with acute leukemias, accelerated\u002Fblast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma\n* Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases\n* Inability to comply with study and follow-up procedures\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":253,"type":20},[159],"This phase I trial compares the effect of lutetium Lu 177 (177\\^Lu)-prostate-specific membrane antigen (PSMA)-617 in combination with Sipuleucel-T to 177\\^Lu-PSMA-617 alone in treating patients with prostate that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow and spread despite surgical or medical intervention to block androgen production (castration-resistant). 177\\^Lu-PSMA-617, a type of radioconjugate, binds to a protein called PSMA, which is found on some prostate tumor cells. It gives off radiation that may kill the tumor cells. Sipuleucel-T, a type of vaccine and a type of cellular adoptive immunotherapy, is made from immune system cells. The cells are treated with a protein that is made by combining a protein found on prostate tumor cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells to kill prostate tumor cells. Giving 177\\^Lu-PSMA-617 in combination with sipuleucel-T may be safe, tolerable, and\u002For effective compared to 177\\^Lu-PSMA-617 alone in treating patients with metastatic castration-resistant prostate cancer.",[26,27],"2026-04-16",{"date":387,"type":32},"2026-04-20",{"date":389,"type":32},"2026-03-06",{"date":391,"type":20},"2028-07-26",{"name":393,"class":39},"City of Hope Medical Center",{"id":395,"slug":4,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":91,"minAge":17,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":21,"phases":402,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":40},"100415725","NCT04693377","Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial","Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases","Inclusion Criteria:\n\n* Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha\u002Fbeta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma\n* A target lesion the meets the following criteria:\n\n  * The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs)\n  * The target lesion must be =\\\u003C 7cm\n  * The pain due to the target lesion must be at least 4\u002F10 based on the BPI pain scale\n  * Pain from the metastatic site must correlate with an identifiable tumor on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) imaging\n* Life expectancy \\>= 3 months\n* Platelet count \\> 50,000\u002Fmm\\^3 within 6 weeks of screening\n* International normalized ratio (INR) \\\u003C 1.5 within 6 weeks of screening\n* If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin \\[LMWH\\] preparations)\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%) within 6 weeks of screening\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization\n* All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery\n* Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator\n* Target lesions that involve the spinal column or calvarium\n* Absolute neutrophil count \\\u003C 1000 mm\\^3 within 6 weeks of screening\n* Active infection\n* Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization\n* Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing \\> 50% loss of cortical bone. Lesions involving the hands and feet",{"count":401,"type":20},40,[403],"NA","This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Bone is a common site of metastasis in advanced cancer, and bone metastases often result in debilitating cancer-related pain. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.",[257,406,344,407,408,204,409,410,411,412,413,299,137,414,259,415,27,416],"Metastatic Colorectal Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Renal Cell Carcinoma","Metastatic Sarcoma","Metastatic Thyroid Gland Carcinoma","Metastatic Urothelial Carcinoma","Stage IV Colorectal Cancer AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2026-04-10",{"date":419,"type":32},"2026-04-15",{"date":421,"type":32},"2021-03-16",{"date":423,"type":20},"2027-04-01",{"name":425,"class":39},"M.D. Anderson Cancer Center",{"id":427,"slug":4,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":91,"minAge":17,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":21,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":40},"100447983","NCT05113537","Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer","Phase I\u002FII Study of CDK4\u002F6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy","UPLIFT","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation.\n2. Age \\>= 18 years.\n3. Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria.\n4. Patients must have adenocarcinoma histology.\n5. Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc.\n6. Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n7. Patients must have a 68Ga-PSMA-11 PET scan with at least one PSMA-positive lesions (maximum standardized uptake value \\[SUVmax\\] greater than SUVmax of liver) as determined by nuclear medicine review prior to start of lead-in treatment with abemaciclib\n8. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2\n9. Patients must have life expectancy of \\> 6 months\n10. Patients must have adequate organ function as outlined below and bone marrow reserve\n\n    * White blood cell (WBC) \\> 2.5\n    * Absolute neutrophil count (ANC) \\> 1.5\n    * Hemoglobin (Hgb) \\>= 8.0 \\[Note- Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\\]\n    * Platelets (Plt) \\>= 100 x 10\\^9\u002FLiter (100,000\u002FMicroliter)\n    * Total bilirubin =\\\u003C 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =\\\u003C 2 ULN and direct bilirubin within normal limits is permitted\n    * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Creatinine =\\\u003C 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation.\n11. Patient must be able to swallow oral medications\n12. Patients must have the ability to understand a written informed consent document, and the willingness to sign it\n13. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n14. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n15. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n16. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n17. Patients with reproductive potential must agree to use effective contraception and to not donate sperm during the study and for at least 2 months following the last dose of study treatment. Effective method of contraception means male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, or cervical cap with spermicide\n\nExclusion Criteria:\n\n1. Patients with small cell or neuroendocrine carcinoma histology.\n2. Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake relative to soft tissue\n3. Patients with prior treatment with CDK4\u002F6 inhibitors\n4. Patients with prior treatment with PSMA-targeted radioligand therapy. Patients with previous treatment with PSMA targeting therapies (Such as Chimeric antigen receptor T cells (CAR-T) or Bi-specific T-cell engagers (BiTEs) are eligible.\n5. Patients treated with Radium-223 within 6 weeks prior to study entry.\n6. Any systemic anti-cancer therapy within 3 weeks of study entry\n7. Patients who have experienced significant radiation-related adverse events (AEs) from prior radiation treatment (\\>= grade 3) or have experienced persistent radiation-related AEs that have not resolved by the time of study randomization\n8. Patients with a history of central nervous system (CNS) metastases are ineligible unless they have received prior therapy (surgery, radiation therapy (RT), gamma knife) are asymptomatic, and not receiving corticosteroids for this indication. Head imaging is not required\n9. Patients with symptoms of cord compression or impending cord compression\n10. Patients with concurrent serious medical conditions as determined by primary investigator\n11. Patients with other significant malignancies that are expected to alter life expectancy or interfere with disease assessment. Patients with adequately treated skin cancer, non-muscle-invasive bladder cancer and patients with prior history of malignancy who have been disease free for more than 2 years are eligible. Patients with history of in-situ\u002Fearly stage melanoma will not be excluded\n12. Patients who have not recovered from adverse events due to prior anti-cancer therapy to =\\\u003C grade 1 or baseline (other than alopecia or peripheral neuropathy)\n13. Patients with serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n14. The patient has active systemic bacterial infection (requiring intravenous (IV) antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment\n15. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n16. Patients currently receiving any other investigational therapeutic agents.",{"count":253,"type":20},[159,23],"This phase I\u002FII trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.",[257,54,299,259,27,437,438],"Metastatic Castration-resistant Prostate Carcinoma","Metastatic Castration-resistant Prostate Cancer","2026-04-09",{"date":441,"type":32},"2026-04-13",{"date":443,"type":32},"2022-07-08",{"date":265,"type":20},{"name":446,"class":39},"Vadim S Koshkin",{"id":448,"slug":4,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":21,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":467},"100534836","NCT06244004","FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial","A Randomized Open Label Phase II Trial of FDG-PET-Guided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY Trial: PET- Guided Radiotherapy Consolidation","Inclusion Criteria:\n\n* Patients must have metastatic prostate cancer on conventional imaging (CT scan, MRI, and\u002For bone scan).\n\n  * Note; Patients who had metastatic disease on conventional imaging prior to beginning ADT, but which has now resolved, are still eligible if they meet remaining eligibility criteria\n* Patients must be ≥ 18 years of age at the time of informed consent.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n* Planned treatment requirements:\n\n  * Cohort 1\n\n    * Patients must have mHSPC and be planning therapy with cytotoxic therapy, with or without an androgen receptor (AR) pathway inhibitor (ARPI), to be eligible for Cohort 1. Patients may also enroll if they are currently receiving or have completed cytotoxic therapy, if they are within 26 weeks +\u002F- 4 weeks (30 weeks) of starting cytotoxic therapy and 26 weeks +\u002F- 26 weeks (one year) of starting ADT.\n\n      * Note:\n\n        * Typically cytotoxic therapy means docetaxel. Patients planning other cytotoxic therapy (e.g. cabazitaxel) should discuss this with the study principal investigator (PI).\n        * If a patient registers as part of cohort 1 but ends up not receiving any cytotoxic therapy, the patient may be switched to cohort 2. This must be discussed with the study PI. If the patient received at least one cycle of cytotoxic therapy, they would remain in cohort 1.\n        * Patients will continue their standard of care treatment while on study (plus MDRT if they are on Arm 1A). Change in standard of care therapy will be allowed for toxicity or for de-escalation, and the patient will remain on study. Change in therapy for progression is considered a progression event.\n  * Cohort 2\n\n    * Patients must have mHSPC and be planning therapy with androgen deprivation therapy (ADT), with or without an ARPI, and not planning cytotoxic therapy, to be eligible for Cohort 2. Patients may also enroll if they are within 26 weeks +\u002F- 4 weeks (30 weeks) of starting an AR pathway inhibitor and 26 weeks +\u002F- 26 weeks (one year) of starting ADT.\n\n      * Note:\n\n        * If patients register as part of cohort 2 but end up receiving one or more cycles of cytotoxic therapy, they may be switched to cohort 1. This must be discussed with the study PI.\n        * Patients will continue their standard of care treatment while on study (plus MDRT if they are on Arm 2A). If they switch therapy because of progression, they will be considered to have progressed.\n        * Patients can be enrolled anytime within the initial \\~6 month standard of care time period, though early enrollment is preferred. Screening can take place prior to starting standard of care (SOC) therapy or during standard of care therapy, as long as they are within 30 weeks of starting therapy.\n* Leukocytes (WBC) ≥ 2,500\u002FmcL (growth factor use allowed) (obtained prior to registration).\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (growth factor use allowed) (obtained prior to registration).\n* Platelets (PLT) ≥ 80,000\u002FmcL (transfusions allowed) (obtained prior to registration).\n* Patient must be able to lie flat and still for approximately 15-20 minutes AND able to tolerate FDG-PET\u002FCT radiographical imaging and radiation treatment planning and delivery.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the endpoints for this study, in the opinion of the treating investigator, are eligible.\n\n  * Note; Patients are ineligible if another known malignancy makes it difficult to interpret if FDG-avid lesions represent prostate cancer, or if the malignancy is expected to interfere with patients receiving standard therapy for prostate cancer for 2 years from study enrollment.\n* Patients must have a life expectancy of at least 6 months, in the opinion of the treating investigator.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.\n\n  * Note: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\n\nExclusion Criteria:\n\n* Patients with prostate cancer that is castration resistant, which is defined as two consecutive rising PSA values despite testosterone level \\\u003C 50 ng\u002FdL.\n* Patients who started androgen deprivation therapy (ADT) more than 26 weeks +\u002F- 26 weeks (1 year) prior to enrollment.\n\n  * Note: ADT is defined as luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix, relugolix) or surgical castration. Bicalutamide 50 mg daily does not count as ADT.\n  * Note: Patients will not be excluded if they were previously on intermittent therapy, as long as the current \"on\" period started within one year of enrollment.\n* Patients who started intensification of therapy beyond ADT (e.g., AR pathway inhibitor, cytotoxic therapy) more than 26 weeks +\u002F- 4 weeks (30 weeks) prior to registration.\n\n  * Note: First generation antiandrogens (bicalutamide) are not considered intensification of therapy beyond ADT.\n* Subjects with a known allergy to contrast material and\u002For contraindication to FDG-PET\n\n  * Note: Contrast allergies: Patients with a known allergy to imaging contrast agent(s) are eligible, provided prior reactions have not been severe, and the patient is willing and able to receive pre-medications and\u002For supportive care according to institutional standard practice (e.g., corticosteroids, antihistamines, etc.) to manage reactions adequately.\n* Patients who are enrolled in another therapeutic clinical trial that would preclude them from participating in this trial.",{"count":454,"type":20},125,[23],"This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.",[77,204,27],"2026-03-27",{"date":460,"type":32},"2026-03-30",{"date":462,"type":32},"2024-02-18",{"date":464,"type":20},"2028-02-18",{"name":466,"class":39},"Northwestern University",6,{"id":469,"slug":4,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":374},"100556530","NCT06526299","Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease","A Phase 2 Study of Biomarker-Modulated PSMA Theranostics","Inclusion Criteria:\n\n* Patients must have the ability to understand and sign an approved informed consent.\n* Patients must have the ability to understand and comply with all protocol requirements.\n* Patients must be ≥ 18 years of age.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Patients must have a life expectancy \\> 6 months.\n* Patients must have histological, pathological, and\u002For cytological confirmation of prostate cancer.\n* Patients must have a positive 68Ga-PSMA PET\u002FCT scan with no PSMA negative lesion, as determined by the Nuclear Medicine site investigator. The presence of PSMA-positive lesions was defined as 68Ga-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system. PSMA negative disease defined as lymph nodes of 2.5 cm or visceral lesions or soft tissue component of a lytic bone lesion of 1.0 cm or larger with uptake less than that of liver parenchyma.\n* Patients must have whole body tumor SUVmean of \\\u003C 10 on 68Ga-PSMA PET\u002FCT scan, as determined by the Nuclear Medicine site investigator. 68GaPSMA PET\u002FCT will be analyzed using a semi-quantitative approach with MIM software (MIM Software Inc.). The workflow identified whole-body regions of interest (ROIs) with an maximum standardized uptake value (SUVmax) greater than 3 and a lesion size of at least 0.5 mm. The reviewer then manually removes any instances of physiological activity or uptake that are not related to the disease. The method of whole-body quantification will automatically calculate the whole body SUVmean.\n* Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL) at the most recent evaluation before enrollment.\n* Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (such as enzalutamide and\u002For abiraterone).\n* Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:\n\n  * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL.\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.\n  * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Working Group 3 (PCWG3) criteria, Scher et al 2016).\n* Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤ 45 days prior to beginning study therapy. Measurable disease by per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 is not required, as prostate cancer patients may not have RECIST-measurable disease but have detectable disease on bone scan.\n* Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).\n* White blood cell (WBC) count ≥ 2.5 x 10\\^9\u002FL (2.5 x 10\\^9\u002FL is equivalent to 2.5 x 10\\^3\u002FuL and 2.5 x K\u002FuL and 2.5 x 10\\^3\u002Fcumm and 2500\u002FuL) OR absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (1.5 x 10\\^9\u002FL is equivalent to 1.5 x 10\\^3\u002FuL and 1.5 x K\u002FuL and 1.5 x 10\\^3\u002Fcumm and 1500\u002FuL).\n* Platelets ≥ 100 x 10\\^9\u002FL (100 x 10\\^9\u002FL is equivalent to 100 x 10\\^3\u002FuL and 100 x K\u002FuL and 100 x 10\\^3\u002Fcumm and 100,000\u002FuL).\n* Hemoglobin ≥ 9 g\u002FdL (9 g\u002FdL is equivalent to 90 g\u002FL and 5.59 mmol\u002FL).\n* Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's syndrome ≤ 3 x ULN is permitted.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases.\n* Albumin \\> 3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL).\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n* HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients who have partners of childbearing potential: Partner and\u002For patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 14 weeks after last study drug administration. The patients should not donate sperm throughout the treatment period and for 14 weeks following the last treatment.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to treatment day 1. Previous PSMA-targeted radioligand therapy is not allowed.\n* Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]) within 30 days prior to treatment day 1.\n\n  * Concurrent bone strengthening agents such as bisphosphonates (such as zolendronic acid) and RANKL inhibitors (such as denosumab) are allowed.\n* Any investigational agents within 30 days prior to treatment day 1.\n* Known hypersensitivity to the components of the study therapy or its analogs.\n* Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n* Transfusion within 30 days of treatment day 1.\n* Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.\n* Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.\n* Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.",{"count":475,"type":20},51,[23],"This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.",[53,27],"2026-03-23",{"date":481,"type":32},"2026-03-24",{"date":483,"type":32},"2025-04-29",{"date":265,"type":20},{"name":38,"class":39},{"id":487,"slug":4,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":40},"100538229","NCT06288113","Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial","Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)","Inclusion Criteria:\n\n* Patients must have mCRPC\n* Patients must have received at least one regimen of chemotherapy for mCRPC\n* Patients must have received at least one androgen receptor signaling inhibitor (ARSI)\n* Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy\n* Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as:\n\n  * PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND\n  * No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy \\[ADT\\] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed\n* Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart\n* Patients must meet PSMA PET\u002FCT VISION criteria. PSMA PET\u002FCT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy\n* White blood cells \\> 2,500 cells\u002FµL\n* Absolute neutrophil count \\> 1,500 cells\u002FµL\n* Hemoglobin \\> 9.0 g\u002FdL\n* Platelets \\> 100,000 cells\u002FµL\n* Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements\n\nExclusion Criteria:\n\n* Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed\n* Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks\n* Patient with creatinine clearance \\\u003C 50 mL\u002Fmin",{"count":401,"type":20},[23],"This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.",[257,27],"2026-03-11",{"date":498,"type":32},"2026-03-13",{"date":500,"type":32},"2024-08-01",{"date":502,"type":20},"2028-01-27",{"name":267,"class":39},{"id":505,"slug":4,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":21,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":40},"100628811","NCT07466498","Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial","Estrogen for Quality-of-Life and Immune Modulation in Prostate Cancer (EQUIP)","Inclusion Criteria:\n\n* Must be willing to provide informed consent prior to any study specific procedures\n* Age ≥ 18 years\n* Documented histologically confirmed adenocarcinoma of the prostate\n* Patients must have evidence of newly diagnosed or relapsed metastatic hormone sensitive prostate cancer on CT, positron emission tomography (PET), MRI or bone scan\n* No prior chemotherapy for the treatment of hormone sensitive prostate cancer\n* No prior therapy with an LHRH analogue or next-generation androgen receptor-signaling inhibitor (e.g. abiraterone, enzalutamide, etc.). Participants may have initiated on a first-generation androgen receptor (AR) antagonist (e.g. bicalutamide) prior to enrollment\n* Hemoglobin ≥ 9 g\u002FdL with no blood transfusion in the past 28 days (measured within 30 days prior to administration of study treatment)\n* Platelet count ≥ 100 x 10\\^9\u002FL (measured within 30 days prior to administration of study treatment)\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (measured within 30 days prior to administration of study treatment)\n* Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT)\u002Falanine aminotransferase (ALT) or serum glutamic pyruvate transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal (measured within 30 days prior to administration of study treatment)\n* Patient must have creatinine clearance estimated using the Cockcroft-Gault equation (measured within 30 days prior to administration of study treatment)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) with exception for Gilbert's syndrome (measured within 30 days prior to administration of study treatment)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Patients must have a life expectancy ≥ 16 weeks\n* Patients must be willing and able to comply with protocol for the duration of the study including undergoing treatment and scheduled visits and examinations\n* At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed at baseline by CT, MRI and\u002For bone scan and is suitable for repeated assessment. Subjects without bone metastases must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n* Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 6 months after last dose of study drug(s) to prevent pregnancy in a partner\n\nExclusion Criteria:\n\n* Involvement in the planning and\u002For conduct of the study\n* Other malignancy unless curatively treated with no evidence of disease for ≥ 2 years. Exceptions include adequately treated non-melanoma skin cancer or non-muscle invasive bladder cancer\n* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patient with spinal cord compression unless considered to have received definitive therapy for this and evidence of clinically stable disease for 28 days\n* Patients considered inappropriate to receive docetaxel chemotherapy by their treating provider\n* Use of corticosteroids at a dose equivalent to \\> 10 mg of prednisone daily\n* Planning to receive concurrent treatment with another systemic cancer therapy, aside from an LHRH analogue\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure \\[BP\\] ≥ 165\u002F100), unstable spinal cord compression, superior vena cava syndrome or extensive interstitial lung disease\n* Patients with a known hypersensitivity to transdermal estradiol, LHRH analogue, ARSIs or any of the excipients of these products\n* Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through body or other body fluids\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study\n* Any psychological, familial, sociological or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule\n* Evidence of a pre-existing condition that, in the opinion of the investigator, would put the patient at risk from estradiol therapy.\n\n  * Some examples include: history of blood clotting disorder, migraines with aura or other focal neurological symptom, angina (New York Heart Association grade III or higher)\n* Prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study and not currently on systemic anticoagulation\n\n  * Excluded due to risk of venous thromboembolism from hormone supplementation\n* Patients with New York Heart Association (NYHA) class III or IV heart failure or history of a prior myocardial infarction (MI) or cerebrovascular accident (stroke or transient ischemic attack) within 5 years of enrollment to the study\n\n  * Excluded due to increased risk of cardiovascular events with estradiol supplementation",{"count":511,"type":20},60,[23],"This phase II trial compares giving estrogen with an androgen receptor signaling inhibitor to standard of care luteinizing hormone-releasing hormone (LHRH) analogues with an androgen receptor signaling inhibitor for improving quality of life for patients with hormone sensitive prostate cancer that is newly diagnosed or that has come back after a period of improvement (recurrent) and has spread from where it first started (primary site) to other places in the body (metastatic). Standard prostate cancer treatment decreases hormone levels, specifically estrogen, in the body which can lead to hot flashes, fatigue, decreased bone health, and cardiovascular and metabolic dysfunction. Transdermal estrogen may help to alleviate these symptoms. Androgen receptor signaling inhibitors work by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. LHRH analogues are a type of androgen deprivation therapy that blocks the use of androgen by the tumor cells. Giving estrogen with androgen receptor signaling inhibitor may improve quality of life in men with newly diagnosed or recurrent metastatic hormone sensitive prostate cancer.",[515,516,27],"Castration-Sensitive Prostate Adenocarcinoma","Metastatic Castration-Sensitive Prostate Adenocarcinoma","2026-03-09",{"date":519,"type":32},"2026-03-12",{"date":521,"type":20},"2026-08-01",{"date":523,"type":20},"2029-06-01",{"name":38,"class":39},{"id":526,"slug":4,"hasResults":11,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":532,"phases":4,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":545},"100400091","NCT04489719","Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer","The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age\n* Patient must have histopathologic diagnosis of prostate cancer\n* Patient must have castration-resistant prostate cancer\n* Patient must have radiographic evidence of bone metastasis\n* Patients must be symptomatic from prostate cancer\n* Patient must have plans to undergo treatment with radium-223\n* Patient must have a PSA level \\>= 10 ng\u002FmL\n* Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening\n* Patient must have anticipated survival \\> 3 months\n* Patient must be willing and able to authorize consent\n* Patient must be willing and able to comply with the protocol, including follow-up visits\n\nExclusion Criteria:\n\n* Patient must not have visceral metastasis\n* Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded\n\n  \\* Bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed\n* Patients who have received prior radium-223\n* Patients who have received prior platinum containing chemotherapy\n* Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL\n* Hemoglobin (HB) \\\u003C 9 g\u002FdL\n* Platelets (PLT) \\\u003C 100 x 10\\^9\u002FL\n* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation",{"count":157,"type":20},"OBSERVATIONAL","This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.",[257,344,204,27],[536],"Prostate","2026-02-12",{"date":539,"type":32},"2026-02-17",{"date":541,"type":32},"2021-04-16",{"date":543,"type":20},"2029-08-01",{"name":38,"class":39},4,{"id":547,"slug":4,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":21,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":40},"100418900","NCT04734730","Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer","Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer","Inclusion Criteria:\n\n* All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. (Note: Gleason score not required if biopsy of metastasis was used to make the histologic diagnosis)\n* All patients must have metastatic disease: either soft tissue and\u002For bony metastases prior to initiation of androgen. Measurable disease is not required\n* Baseline imaging must have been performed within 42 days before or 14 days after initiating luteinizing hormone releasing hormones (LHRH) therapy. All disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Patients may have started on LHRH therapy for metastatic prostate cancer provided this was initiated no longer than 60 days prior to registration\n\n  * Patients may have received neoadjuvant and\u002For adjuvant LHRH therapy during definitive treatment or salvage radiation; if so at least 12 months must have elapsed from the last LHRH injection and baseline testosterone must be \\> 150 ng\u002FdL\n  * No restriction on bicalutamide used for flare prevention or combined therapy however bicalutamide must be stopped at registration\n* Patients must have a Karnofsky performance status of 60 - 100\n* Men of reproductive potential and those who are surgically sterilized (i.e., vasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends\n* Bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (obtained within 28 days prior to registration)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 2.5 x institutional ULN, or =\\\u003C 5 x institutional ULN if liver metastases are present (obtained within 28 days prior to registration)\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin using a serum creatinine obtained within 28 days prior to registration\n* Leukocytes \\>= 3,000\u002FmcL (obtained within 28 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (obtained within 28 days prior to registration)\n* Hemoglobin \\>= 9 g\u002FdL (obtained within 28 days prior to registration)\n* Platelets \\>= 100,000\u002FmcL (obtained within 28 days prior to registration)\n* All subjects must have the ability to understand and the willingness to sign a written informed consent\n* Patients may have received prior androgen deprivation therapy (ADT) -neoadjuvant and\u002For adjuvant, or in conjunction with salvage radiation - but it must not have lasted for more than 36 months. Single or combination therapy allowed. At least 6 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and\u002For adjuvant setting, and serum testosterone must be \\> 150 ng\u002FmL within 28 days prior to registration. Note: Serum testosterone assessment is required for eligibility for only those with prior treatment with ADT\n\n  * Patients who have already started on LHRH therapy are eligible, provided no more than 60 days have elapsed from LHRH injection (or surgical castration) for metastatic prostate cancer prior to registration. The start date of medical castration is considered the day the patient first received an injection of a LHRH agonist\u002Fantagonist (or orchiectomy), not an oral antiandrogen. Subjects may not already be taking abiraterone, enzalutamide, apalutamide or other intensification agent during this time - bicalutamide is permitted\n* Patients may have received palliative radiotherapy for symptomatic bone or visceral metastasis, provided they have recovered from all side effects at the time of registration\n* Patients may have received prior surgery. For all major surgeries, at least 14days must have elapsed since completion and patient must have recovered from all major side effects of surgery per investigator's assessment\n* Patients may have received or plan to receive concurrent bone targeting agents that do not have an effect on prostate specific antigen (PSA) (e.g. denosumab or bisphosphonate)\n\nExclusion Criteria:\n\n* Patients must not have received prior and\u002For must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed\n* Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer\n\n  * Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting may be allowed at the discretion of the principal investigator. At least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and\u002For adjuvant setting\n* Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. But, if brain imaging studies are performed, they must be negative for disease\n* Patients must not have New York Heart Association class III or IV heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration\n* Patients must not have uncontrolled hypertension (defined as blood pressure \\> 160 mmHg systolic and \\> 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart) despite appropriate medical therapy. Note: Patients may be rescreened after adjustments of antihypertensive medications\n* Patients must not be known to have human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study\n* Patients with a known history of primary and secondary adrenal insufficiency are not eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs\n* Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. Previous experimental therapy must have been completed at least 28 days prior to registration\n* Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of any of the study drugs, including difficulty swallowing oral medications\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years",{"count":553,"type":20},70,[23],"This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Androgen can cause the growth of prostate tumor cells. Degarelix, leuprolide acetate, bicalutamide, goserelin acetate, and abiraterone lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Giving talazoparib with androgen deprivation therapy and abiraterone may improve cancer control for patients with castration sensitive prostate cancer.",[77,54,299,259,27],"2026-01-27",{"date":559,"type":32},"2026-01-28",{"date":561,"type":32},"2021-05-04",{"date":563,"type":20},"2027-08-23",{"name":393,"class":39},{"id":566,"slug":4,"hasResults":11,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":21,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":40},"100527274","NCT06145633","Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer","Vorinostat to Augment Response to 177Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Documented histologically confirmed adenocarcinoma of the prostate.\n* Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 \\[PCWG3\\] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg\u002FdL).\n* PSMA SUVmean \\\u003C 10 as determined by 68Ga-PSMA-11 PET.\n* Patients must have received a next-generation androgen receptor-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). There must be at least a 2-week washout period after stopping these agents. Patients should be weaned off steroids at least 1 week prior to starting treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed at baseline by CT and\u002For bone scan and is suitable for repeated assessment.\n* Hemoglobin ≥ 10 g\u002FdL (measured within 28 days prior to administration of study treatment)\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (measured within 28 days prior to administration of study treatment)\n* Platelet count ≥ 100 x 10\\^9\u002FL (measured within 28 days prior to administration of study treatment)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)\n* Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN (measured within 28 days prior to administration of study treatment) . For patients with known Gilbert's Syndrome they must be ≤ 3 x ULN (measured within 28 days prior to administration of study treatment)\n* Calculated creatinine clearance ≥ 50 mL\u002Fmin (using Cockcroft-Gault formula) (measured within 28 days prior to administration of study treatment)\n* Patients and their partners, who are sexually active and of childbearing potential must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 3 months after last dose of study drug to prevent pregnancy in a partner.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.\n\nExclusion Criteria:\n\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or provision of informed consent to participate in this study.\n* Evidence of metastatic neuroendocrine\u002Fsmall cell prostate cancer (NEPC). Note: baseline biopsy is not required but is strongly encouraged if a patient is found to have an FDG-positive\u002FPSMA-negative lesion on baseline imaging.\n* Patients receiving any systemic therapy (aside from an luteinizing hormone-releasing hormone \\[LHRH\\] analogue) or radiotherapy within 2 weeks prior to study treatment.\n* Any previous treatment with an HDAC inhibitor (including valproic acid) or 177Lu-PSMA-617.\n* Persistent toxicities (CTCAE grade \\>2) from prior cancer therapy, excluding alopecia and stable neuropathy.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or active, uncontrolled infection. Examples include, but are not limited to uncontrolled seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n* Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count \\\u003C 200.\n* Patients with known active hepatitis (i.e. Hepatitis B or C). Prior Hep C infection is allowed as long as polymerase chain reaction (PCR) is negative.\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Deep vein thrombosis or pulmonary embolism diagnosed within the past six months.\n* Active use of coumarin-derived anticoagulant medication (i.e. warfarin).\n* Serious cardiac disorder, including but not limited to uncontrolled ventricular arrhythmia, recent (within 12 months) myocardial infarction, resting electrocardiogram (ECG) indicating Fridericia's corrected QT interval prolongation \\> 500ms, or congenital long QT syndrome.",{"count":572,"type":20},15,[23],"This phase II trial tests how well vorinostat works in treating patients with prostate-specific membrane antigen (PSMA)-low castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) (mCRPC). Prostate cancer that has not spread to other parts of the body (localized) is typically treated through surgery or radiotherapy, which for many men is curable. Despite definitive local therapy, cancer that has come back after a period of improvement (recurrent) disease develops in 27-53% of men. Often this is detected by measurement of prostate-specific antigen (PSA) without visible evidence of metastatic disease. Lutetium Lu 177 vipivotide tetraxetan (177Lu-prostate specific membrane antigen \\[PSMA\\]-617) is a new small molecule PSMA-targeted radioactive therapy that has been approved by the Food and Drug Administration for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor inhibitors and taxane-based chemotherapy. Vorinostat is used to treat various types of cancer that does not get better, gets worse, or comes back during or after treatment with other drugs. Vorinostat is a drug which inhibits the enzyme histone deacetylase and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat and 177Lu-PSMA-617 may kill more tumor cells in in patients with PSMA-low mCRPC.",[257,54,27],"2026-01-26",{"date":559,"type":32},{"date":579,"type":32},"2024-09-18",{"date":581,"type":20},"2027-12-30",{"name":170,"class":39},{"id":584,"slug":4,"hasResults":11,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":21,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":603},"100552219","NCT06470243","Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body","A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC), Stratified by Aggressive Variant Signature","Inclusion Criteria:\n\n* STEP 1 SCREENING REGISTRATION: NOTE: All participants must have biopsy tissue submitted to MD Anderson Cancer Center prior to randomization for alteration assessment. Participants must have determination of their AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status from central assessment by the MD Anderson Clinical Pathology Laboratory using Clinical Laboratory Improvement Act (CLIA) certified immunohistochemistry (IHC) assays for TP53, RB1 and PTEN. In addition, while not mandated, CLIA certified next generation sequencing (NGS) of tumor deoxyribonucleic acid (DNA) and\u002For circulating tumor derived DNA (ctDNA) assessment of AVPC-MS marker status will be collected from participants for whom it is available\n* STEP 1 SCREENING REGISTRATION: Participants must have a histologically confirmed diagnosis of prostate cancer at the time of step 1 registration\n* STEP 1 SCREENING REGISTRATION: Participants must have castrate-resistant prostate cancer and metastatic disease by bone scan and\u002For CT\u002FMRI (i.e., soft tissue, visceral, lymph node)\n* STEP 1 SCREENING REGISTRATION: Participants may have received any prior therapy, but one must be docetaxel or contain docetaxel in either the castrate-sensitive and\u002For castrate resistant disease state\n* STEP 1 SCREENING REGISTRATION: Participants must be ≥ 18 years of age at the time of step 1 screening registration\n* STEP 1 SCREENING REGISTRATION: Participants must have solid tumor biopsy material (formalin-fixed paraffin-embedded (FFPE) tissue blocks and\u002For 10 cut slides on four-micron thick unstained positive charged slides of FFPE tissue) available for submission for alterations in TP53, RB1 and PTEN by IHC using CLIA certified assays in the MD Anderson Clinical Pathology Laboratory. This specimen is required for central assessment of the AVPC-MSIHC regardless of whether the site has already locally evaluated the AVPC-MS status\n* STEP 1 SCREENING REGISTRATION: Tumor samples submitted for analysis must have been collected within 12 months prior to step 1 screening registration. Samples from metastatic lesions collected in the castrate-resistant disease state are preferable but not mandatory. Samples obtained during the hormone-naive disease state are acceptable if collected within 12 months of step 1 screening registration. If more than one tumor sample exists, the sample obtained closest to the date of registration should be submitted to MDACC for analysis\n\n  * NOTE: Sites will receive an email from Southwest Oncology Group (SWOG) Statistics and Data Management Center containing participant results of Aggressive Variant Prostate Cancer Molecular Signature (AVPC-MS) assessment within 5-12 business days after tissue submission to MD Anderson Clinical Pathology Laboratory. The participant's AVPC-MS signature result (positive or negative) is required BEFORE randomization on to step 2. If sites receive a non-evaluable AVPC-MS signature result, SWOG Statistics and Data Management Center will provide instructions for resubmission\n* STEP 1 SCREENING REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 1 SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. Documentation of informed consent via remote consent is allowed\n\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2 RANDOMIZATION: NOTE: Participants must be registered to step 2 randomization within 70 days after registration to step 1. Participants must plan to start protocol therapy no more than 14 days after step 2 randomization\n* STEP 2 RANDOMIZATION: Participants must have castrate levels of testosterone with a baseline level \\\u003C 50ng\u002FdL within 28 days prior to step 2 randomization\n* STEP 2 RANDOMIZATION: Participants must have evidence for metastatic prostate cancer by bone scan and\u002For CT\u002FMRI (i.e., soft tissue, visceral, lymph node). Visceral and\u002For soft-tissue metastases must be ≥ 1.0 cm in diameter and lymph nodes must be \\> 1.5 cm diameter in the short axis. Scans must be obtained within 28 days prior to randomization\n\n  * NOTE: All disease must be assessed and documented on the baseline\u002Fpre-registration tumor assessment form\n* STEP 2 RANDOMZIATION: Participants must have progressive disease (PD) in the opinion of the treating investigator according to any of the following criteria\n\n  * Progression in measurable disease (RECIST 1.1 criteria). Patient with measurable disease must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) \\[CT scan thickness no greater than 5 mm\\] or magnetic resonance imaging (MRI). Lymph nodes should be ≥ 15 mm in short axis. Previously irradiated lesions, primary prostate lesion and bone lesions will be considered non-measurable disease\n  * Progression in bone as evidenced by:\n\n    * Appearance of 2 or more new bone lesions on bone scan (BS). If equivocal, they must be confirmed by other imaging modalities (CT; MRI), and\u002For repeat BS \\> 4 weeks later\n    * Appearance of a new lytic lesion(s) and\u002For increasing size of an existing lesion by CT\u002FMRI, since AVPC tumors may produce lytic bone lesions that are not detected on conventional bone scans\n  * Rising prostate-specific antigen (PSA) defined (Prostate Cancer Working Group 2 \\[PCWG2\\]) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart. The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA measure is required to be taken and be greater than the 2nd measure. In case of progression based on rising PSA only, the first rising PSA (measure 2) must be obtained within 6 months of initiation of androgen receptor (AR) targeted therapy (≤ 6 months)\n  * Clinical progression. Increasing symptoms unequivocally attributed to disease progression as judged by the treating physician\n* STEP 2 RANDOMIZATION: Participants must not have received prior cabazitaxel or carboplatin\n* STEP 2 RANDOMIZATION: Participants must not be receiving treatment on another therapeutic clinical trial at the time of randomization. Chemotherapies, bone targeting therapies, immunotherapies and clinical trial agents must be discontinued ≥ 21 days prior to randomization. Stereotactic radiation (SART) must be discontinued ≥ 3 days prior to randomization\n* STEP 2 RANDOMIZATION: Participants must not be receiving radiation therapy or kyphoplasty-vertebroplasty within 14 days prior to randomization or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days prior to step 2 randomization\n* STEP 2 RANDOMIZATION: Participants must not have untreated fractures and\u002For cord compression\n* STEP 2 RANDOMIZATION: Participants must not have symptomatic uncontrolled brain metastases. Properly treated brain metastases (i.e., with stereotactic radiation) within 14 days are allowed\n* STEP 2 RANDOMIZATION: Participants must have Zubrod performance status of 0 - 2 within 28 days prior to step 2 randomization\n* STEP 2 RANDOMIZATION: Participants must have a complete medical history and physical exam within 28 days prior to step 2 randomization\n* STEP 2 RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to step 2 randomization)\n* STEP 2 RANDOMIZATION: Platelets ≥ 100 x 10\\^3\u002FuL (unless clinical evidence of bone marrow infiltration by tumor in which case \\> 75 x 10\\^3\u002FuL are allowed) (within 28 days prior to step 2 randomization)\n* STEP 2 RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome or if the participant has liver metastases and\u002For acute tumor associated illness \\\u003C 4x ULN (within 28 days prior to step 2 randomization)\n* STEP 2 RANDOMIZATION: Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 × institutional ULN (or if participant has liver metastases and\u002For acute tumor-associated illness, ≤ 4x institutional ULN) (within 28 days prior to step 2 randomization)\n* STEP 2 REGISTRATION: Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 randomization\n* STEP 2 RANDOMIZATION: Participants with peripheral neuropathy must have ≤ grade 2 peripheral neuropathy (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) (within 28 days prior to step 2 randomization)\n* STEP 2 RANDOMIZATION: Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen\n* STEP 2 RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen\n* STEP 2 RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* STEP 2 RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System",{"count":590,"type":20},528,[50],"This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.",[257,27],"2026-01-21",{"date":596,"type":32},"2026-01-22",{"date":598,"type":32},"2024-11-27",{"date":600,"type":20},"2034-04",{"name":602,"class":215},"SWOG Cancer Research Network",174,""]