[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iva-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iva-prostate-cancer-ajcc-v8":351},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,41,68,93,116,150,171,197,223,244,266,290,311,332],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100511958",false,"NCT05946213","Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer","The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer\n* High-risk disease defined as having at least one or more of the following:\n\n  * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[Ed.\\]) Note: cT4 by imaging or on digital rectal exam is not allowed\n  * The patient's prostate specific antigen (PSA) value \\> 20 ng\u002FmL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors\n  * Gleason Score of 8-10\n  * Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm\n* Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan\n* No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* No prior radical prostatectomy\n* No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \\[HIFU\\], laser ablation, cryotherapy, irreversible electroporation \\[IRE\\], and vascular-targeted photodynamic therapy)\n* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \\[LHRH\\] agonist and oral anti-androgen) is =\\\u003C 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease\n* No contraindication to prostate MRI (required for planning of radiotherapy in both arms)\n* Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy","MALE","18 Years",{"count":18,"type":19},1209,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.",[25,26,27],"Prostate Adenocarcinoma","Stage III Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":32},"2023-12-14",{"date":36,"type":19},"2036-03-31",{"name":38,"class":39},"NRG Oncology","OTHER",413,{"id":42,"slug":4,"hasResults":10,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100435211","NCT04947254","Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer","Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer","Inclusion Criteria:\n\n* Completion of informed consent prior to any study specific procedures. Consent may be done remotely.\n* Patients must agree to tissue collection for correlative studies at the specified timepoints\n* Male aged 18 years and above\n* Histologically or cytologically confirmed prostate carcinoma\n* Localized or regional high-risk disease as defined by at least one of the following features: Prostate specific antigen (PSA) \\> 20 ng\u002FmL, T3a or higher, grade group 4-5 (i.e. Gleason score ≥ 8) as per National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 2.2020 for high risk or very high risk prostate cancer, and\u002For regional lymph nodes positive for prostate cancer\n* Planned for definitive treatment of local regional prostate cancer using XRT and androgen ablation\n* Willing to undergo ongoing medical castration to maintain testosterone levels of ≤ 50 ng\u002FdL (≤ 2.0 nM) throughout systemic treatment or have undergone bilateral orchiectomy\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below:\n* Hemoglobin ≥ 10.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL\n* No features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) on peripheral blood smear\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x institutional upper limit of normal\n* Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL\u002Fmin\n* Serum Albumin ≥ 3.0\n* Serum potassium ≥ 3.5 mmol\u002FL\n* Able to swallow study drugs whole as a tablet\u002Fcapsule\n* Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use two methods of birth control including adequate barrier protection during the study and for 4 months after last dose of niraparib, abiraterone acetate, and\u002For apalutamide administration. In addition men should not donate sperm during this period. Please note that the efficacy of hormonal contraception may be decreased if administered with niraparib, abiraterone acetate, and\u002For apalutamide\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 including follow up\n* Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry\n\nExclusion Criteria:\n\n* Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor therapy\n* Patients who have prostate cancer with distant metastatic disease\n* Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer\n* Any unresolved toxicity (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade ≥ 2) from previous anti-cancer therapies\n* History or current diagnosis of MDS\u002FAML, and\u002For history of any malignancy \\[other than the one treated in this study\\] which has a ≥ 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or Ta urothelial carcinomas)\n* Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the principal investigator \\[PI\\]; the PI will serve as the final arbiter regarding eligibility)\n* Active or symptomatic viral hepatitis or chronic liver disease\n* Active pneumonitis or extensive bilateral lung disease of non-malignant etiology\n* Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples include, but are not limited to superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (HRCT) scan, uncontrolled seizures, history of allogeneic organ transplant, history of primary immunodeficiency or any psychiatric disorder that prohibits obtaining informed consent\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of study medication\n* Patients with a known hypersensitivity to niraparib, apalutamide, and\u002For abiraterone acetate\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \\[CNS\\] or meningeal disease which may require treatment with surgery or radiation therapy)\n* Severe or unstable angina, myocardial infarction (within 6 months prior to enrollment), symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), uncontrolled hypertension, or clinically significant ventricular arrhythmias within 6 months prior to randomization\n* Current evidence of any of the following:\n\n  * Gastrointestinal disorder affecting absorption\n  * Active uncontrolled infection (e.g., human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n  * Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone\u002Fprednisolone once daily\n  * Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency\n  * Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate\n  * Baseline moderate and severe hepatic impairment (Child-Pugh class B \\& C)\n  * Any condition that in the opinion of the investigator, would preclude participation in this study",{"count":48,"type":19},200,[50],"PHASE2","This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.",[53,54,26,55,56,57,27],"Prostate Carcinoma","Stage IIC Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","2026-06-19",{"date":60,"type":32},"2026-06-23",{"date":62,"type":32},"2021-08-05",{"date":64,"type":19},"2028-06-07",{"name":66,"class":39},"M.D. Anderson Cancer Center",1,{"id":69,"slug":4,"hasResults":10,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":20,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":67},"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":75,"type":19},30,[77],"PHASE1","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.",[80,81,82,27,83],"Castration-Resistant Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage IVB Prostate Cancer AJCC v8","2026-06-11",{"date":86,"type":32},"2026-06-15",{"date":88,"type":32},"2024-04-26",{"date":90,"type":19},"2027-12-31",{"name":92,"class":39},"Jonsson Comprehensive Cancer Center",{"id":94,"slug":4,"hasResults":10,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":20,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":67},"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":101,"type":19},33,[50],"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.",[80,105,106,27,83],"Metastatic Prostate Adenocarcinoma","Stage IV Prostate Cancer AJCC v8","2026-06-04",{"date":109,"type":32},"2026-06-05",{"date":111,"type":32},"2022-03-29",{"date":113,"type":19},"2027-01",{"name":115,"class":39},"University of Utah",{"id":117,"slug":4,"hasResults":10,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":10,"sex":122,"minAge":16,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":20,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":67},"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","ALL",{"count":124,"type":19},40,[126],"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.",[80,129,130,131,132,81,133,134,135,136,137,106,138,139,27,140,83,141],"Metastatic Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Bone","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 IV Renal Cell 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":144,"type":32},"2026-04-15",{"date":146,"type":32},"2021-03-16",{"date":148,"type":19},"2027-04-01",{"name":66,"class":39},{"id":151,"slug":4,"hasResults":10,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":10,"sex":122,"minAge":16,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":20,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":169,"locationsCount":67},"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":75,"type":19},[77,50],"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.",[80,105,106,27,83,161,162],"Metastatic Castration-resistant Prostate Carcinoma","Metastatic Castration-resistant Prostate Cancer","2026-04-09",{"date":165,"type":32},"2026-04-13",{"date":167,"type":32},"2022-07-08",{"date":90,"type":19},{"name":170,"class":39},"Vadim S Koshkin",{"id":172,"slug":4,"hasResults":10,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":10,"sex":15,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":20,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":67},"100546042","NCT06389786","Accuracy of 18F-rhPSMA-7.3 PET\u002F MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer","MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET\u002FCT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis","Inclusion Criteria:\n\n* Male subjects ≥ 30 and ≤ 85 years old\n* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)\n* Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling\n* Planned elective radical prostatectomy with extended pelvic lymph node dissection\n* Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery\n* Patient agrees to comply with the investigator instructions\n* Patient agrees to comply with the follow-up surveillance schedule\n* Have ability to provide full written consent\n\nExclusion Criteria:\n\n* High-risk cancer planned for neoadjuvant therapy\n* Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study\n* Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration\n* Clinical oligometastatic disease with \\> 3 nodes positive preoperative standard of care imaging of prostate region\n* Previous history of pelvic radiation\n* Patients with obesity defined as body mass index (BMI) \\> 40 kg\u002Fm\\^2\n* History of prior laparoscopic inguinal hernia repair with mesh\n* Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period\n* Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging\n* Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments\n* Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment\n* Received administration of an investigational drug within 30 days prior to study registration, and\u002For has planned administration of another investigational product or procedure during participation in this study","30 Years","85 Years",{"count":180,"type":19},50,[126],"This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \\[PET\\]\u002Fmagnetic resonance imaging \\[MRI\\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET\u002Fcomputed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET\u002FCT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET\u002F MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.",[184,185,186,187,26,27],"Localized Prostate Carcinoma","Oligometastatic Prostate Carcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","2026-04-01",{"date":190,"type":32},"2026-04-06",{"date":192,"type":32},"2024-06-11",{"date":194,"type":19},"2027-05-31",{"name":196,"class":39},"Mayo Clinic",{"id":198,"slug":4,"hasResults":10,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":20,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100566084","NCT06650579","REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial","Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial","Inclusion Criteria:\n\n* Men ≥ 18 years old\n* Non-metastatic prostate cancer\n* Non-metastatic, biochemically recurrent prostate cancer\n* Plan to undergo curative-intent pelvic radiation therapy (photons or protons) with or without brachytherapy\n* Plan to undergo up to 24 months of combination androgen deprivation therapy (ADT) plus AA and prednisone\n\nExclusion Criteria:\n\n* Metastatic prostate cancer requiring indefinitive ADT or chemotherapy\n* Prior exposure to androgen deprivation therapy\n* Prior exposure to chemotherapy, immunotherapy, or radiation therapy\n* History of cardiac bypass surgery or percutaneous coronary intervention\n* History of cardiac pacemaker or defibrillator",{"count":204,"type":19},72,[22],"This phase III\u002FIV trial compares the impact of leuprolide and abiraterone acetate (AA) versus relugolix and AA on the heart in hormone-naive patients with advanced prostate cancer receiving pelvic radiation therapy. Leuprolide is in a class of medications called gonadotropin-releasing hormone agonists (GNRHa). It prevents the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate tumor cells that need testosterone to grow. Abiraterone acetate, an androgen biosynthesis inhibitor, works by decreasing the amount of certain hormones in the body. Relugolix, a GNRH antagonist, works by decreasing the amount of testosterone produced by the body. This may slow or stop the spread of prostate tumor cells that need testosterone to grow. The use of hormone therapy with radiation therapy has been shown to improve survival, however, studies have suggested that the addition of hormone therapy may worsen heart (cardiac) disease and high blood pressure. In fact, studies have shown that the most common cause of death in prostate cancer patients is due to heart disease or heart attacks. Computed tomography (CT) scans create a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. In this study, sophisticated cardiac CT images are used to take pictures of patients' heart and coronary arteries to help assess damage to the heart. Using cardiac CT and blood tests, this trial may help doctors determine which patients are at risk of cardiac disease when treated with combination hormone therapy, as well as the differential risk of leuprolide versus relugolix in combination with abiraterone acetate.",[208,26,27],"Recurrent Prostate Carcinoma",[210,211,212],"node-positive prostate cancer","advanced prostate cancer","very-high-risk prostate cancer","2026-02-22",{"date":215,"type":32},"2026-02-24",{"date":217,"type":32},"2025-01-31",{"date":219,"type":19},"2029-07-01",{"name":221,"class":39},"Emory University",4,{"id":224,"slug":4,"hasResults":10,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":20,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":67},"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":230,"type":19},70,[50],"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.",[234,105,106,27,83],"Castration-Sensitive Prostate Carcinoma","2026-01-27",{"date":237,"type":32},"2026-01-28",{"date":239,"type":32},"2021-05-04",{"date":241,"type":19},"2027-08-23",{"name":243,"class":39},"City of Hope Medical Center",{"id":245,"slug":4,"hasResults":10,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":10,"sex":15,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":20,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100503704","NCT05838716","Vitamin D for Prostate Endocrine Therapy","High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients","ViPER","Inclusion Criteria:\n\n* Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)\n* Be age 50 years or older\n* Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \\[LHRH\\] antagonists and LHRH agonists are permitted)\n* Have a total serum vitamin D between 10 and 32 ng\u002Fml\n* Have a total serum calcium of less than or equal to 10.5 mg\u002Fdl\n* Have a normal GFR (glomerular filtration rate \\> 30ml)\n* Agree not to take calcium and\u002For vitamin D supplements for the duration of the intervention other than those provided by the study\n* Be able to provide written informed consent\n* Be able to swallow pills and capsules\n* Be able to speak and read English\n\nExclusion Criteria:\n\n* Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment\n* Have a diagnosis of stage IV chronic kidney disease\n* Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg\u002Fdl)\n* Have a history of hypercalcemia or vitamin D toxicity\u002Fsensitivity","50 Years",{"count":253,"type":19},240,[22],"This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.",[186,187,26,27],"2026-01-14",{"date":259,"type":32},"2026-01-15",{"date":34,"type":32},{"date":262,"type":19},"2029-04-29",{"name":264,"class":39},"University of Rochester",51,{"id":267,"slug":4,"hasResults":10,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":20,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":289},"100337790","NCT03678025","Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer","Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer","Inclusion Criteria:\n\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma\\* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (\\*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound \\[HIFU\\], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride \\[NaF\\], prostate-specific membrane antigen \\[PSMA\\], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid \\[FACBC\\], carbon \\[C\\]11) but not conventional imaging (technetium \\[Tc\\]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: 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. If brain imaging studies are performed, they must be negative for disease.\n* STEP 1 REGISTRATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.\n* STEP 1 REGISTRATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.\n* STEP 1 REGISTRATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, 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 three years.\n* STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.\n* STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.\n* STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the 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 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.\n* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =\\\u003C grade 1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) prior to randomization.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=\\\u003C 4 sites). All treatment must be completed prior to randomization.\n* STEP 2 RANDOMIZATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.\n* STEP 2 RANDOMIZATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a testosterone \\\u003C 50 ng\u002FdL within 28 days prior to randomization.\n* STEP 2 RANDOMIZATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.",{"count":273,"type":19},1273,[22],"This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.",[277,278,106,27,83],"Castration Levels of Testosterone","Metastatic Prostatic Adenocarcinoma","2025-09-04",{"date":281,"type":32},"2025-09-11",{"date":283,"type":32},"2018-09-24",{"date":285,"type":19},"2031-10-01",{"name":287,"class":288},"SWOG Cancer Research Network","NETWORK",338,{"id":291,"slug":4,"hasResults":10,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":20,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":67},"100435087","NCT04945642","High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma","Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)","HYDRA","Inclusion Criteria:\n\n* Ability to understand a written informed consent document, and the willingness to sign it\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* History\u002Fphysical examination with digital rectal examination of the prostate within 8 weeks prior to registration\n* Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \\> 10, and\u002For Gleason score \\>= 7\n* No evidence of disease beyond the prostate and\u002For seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)\n* Prostate size =\\\u003C 60cc\n* International Prognostic Scoring System (IPSS) score =\\\u003C 15\n* Able to safely receive moderate sedation or general anesthesia\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous\u002Fhematogenous malignancy unless continually disease free for a minimum of 5 years\n* Regional lymph node involvement\n* Evidence of distant metastases\n* Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer\n* Previous pelvic irradiation or prostate brachytherapy\n* Previous or concurrent cytotoxic chemotherapy for prostate cancer\n* Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery\n* Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment",{"count":298,"type":19},52,[126],"This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.",[25,302,54,26,55,56,57,27],"Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","2025-07-11",{"date":305,"type":32},"2025-07-15",{"date":307,"type":32},"2021-08-20",{"date":309,"type":19},"2027-07-01",{"name":92,"class":39},{"id":312,"slug":4,"hasResults":10,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":20,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":67},"100432776","NCT04915508","Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy","Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)","EXCALIBUR","Inclusion Criteria:\n\n* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent\n* Presence of any ONE of the following:\n\n  * Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)\n  * Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng\u002FmL\n  * Intermediate- or high-risk Decipher genomic classifier score\n  * Identification of prostate cancer in \\>= 1 lymph node at the time of prostatectomy (pN+ disease)\n* CT scan and MRI of the pelvis within 120 days prior to enrollment \\[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \\\u003C 1.0 ng\u002FmL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\\]\n* Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \\> 1.0 ng\u002FmL\n* Age \\>= 18\n* Karnofsky performance status (KPS) \\>= 70 and\u002For Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Ability to understand, and willingness to sign, the written informed consent\n\nExclusion Criteria:\n\n* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior pelvic radiotherapy\n* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia",{"count":319,"type":19},102,[50],"This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.",[25,323,57,106,27,83],"Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","2025-06-17",{"date":326,"type":32},"2025-06-22",{"date":328,"type":32},"2021-06-23",{"date":330,"type":19},"2027-08-01",{"name":92,"class":39},{"id":333,"slug":4,"hasResults":10,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":20,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":67},"100443430","NCT05054296","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \\[CT\\] and\u002For magnetic resonance imaging \\[MRI\\]) or biochemical recurrence\u002Frefractoriness following local therapy (prostatectomy or radiation)\n* Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months\n* On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months\n* Combination ADT with abiraterone or enzalutamide is permitted\n* Anticipation to remain hypogonadal for at least 6 months subsequently\n* Asymptomatic bone metastasis is permissible (exercise will be modified and patients monitored)\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol \\^70 supervised by a cardiologist\n* Hemoglobin \\>= 9.0 g\u002FdL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Platelet count \\>=75,000\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Access to a smart phone with android or iPhone OS (iOS) operating systems\n* Able to speak and comprehend English\n\nExclusion Criteria:\n\n* Current use of any other systemic therapy for prostate cancer with the exception of gonadotrophin releasing hormone (GnRH) agonists\u002Fantagonists, abiraterone, enzalutamide, bisphosphonates or RANK-ligand inhibitors (for bone metastases) which are allowed\n* Any underlying comorbid medical or psychiatric condition, which in the opinion of the Investigator, will make participation in our exercise intervention hazardous or obscure the interpretation of adverse events\n* Inability to walk 400 meters or undertake upper and lower limb exercise, and resistance training in the previous 3 months\n* Chemotherapy treatment within 28 days of study enrollment\n* Symptomatic bone metastasis\n* Any investigational pharmaceutical products\n* Radiation therapy or surgical intervention for prior bone metastasis\n* Clinically significant active malignancy other than prostate cancer\n* Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\\>= 450 m\u002Fsec)\n* Clinically significant heart disease that may impact safety of independent or supervised exercise including preexisting coronary artery disease, myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of \\\u003C 40% at baseline\n* Untreated symptomatic spinal cord compressions\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness",{"count":48,"type":19},[50],"This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.",[342,105,106,27,83],"Biochemically Recurrent Prostate Carcinoma","2023-03-28",{"date":345,"type":32},"2023-03-29",{"date":347,"type":32},"2020-03-23",{"date":349,"type":19},"2027-02-02",{"name":66,"class":39},""]