[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-adenocarcinoma":635},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,65,0,25,[9,45,68,89,124,147,169,193,219,241,265,293,326,348,368,390,409,436,458,483,515,536,557,577,598],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053734",false,"NCT07364071","Strategic Endocrine Therapy and Targeted Radiotherapy for Prostate Cancer","Strategic ENdocrine and Targeted Radiation therapY","SENTRY","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the prostate.\n2. High-risk localized prostate cancer, defined as ≥1 of the following (per National Comprehensive Cancer Network or D'Amico criteria):\n\n   1. Prostate specific antigen ≥ 20 ng\u002FmL\n   2. Gleason score 8-10\n   3. Clinical stage T3a or higher; imaging can be used to determine T stage if there is macroscopic (gross) extraprostatic extension or invasion of the seminal vesicles or other non-prostate organs\n3. No evidence of distant metastasis, confirmed by:\n\n   a. Prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography (PSMA PET\u002FCT) or equivalent staging imaging\n4. Planning to receive definitive external beam radiotherapy and hormone therapy as standard of care (on label or medically accepted) treatment\n5. Eastern Cooperative Oncology Group performance status 0-1.\n6. Age ≥ 18 years.\n7. Willingness to use adequate contraception if sexually active and of reproductive potential\n8. Ability to understand and willingness to sign informed consent.\n9. Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. Evidence of metastatic disease, including nodal disease beyond the pelvis or distant metastases on imaging.\n2. Clear evidence of regional nodal disease on conventional imaging.\n3. Prior prostatectomy.\n4. Prior systemic therapy for prostate cancer, including:\n\n   1. Androgen deprivation therapy (Note that participants who have started Androgen deprivation therapy within 90 days prior to randomization can be enrolled.)\n   2. Androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).\n   3. Chemotherapy for prostate cancer.\n5. Prior pelvic radiotherapy.\n6. Any condition that, in the investigator's judgment, would compromise the patient's safety or compliance.","MALE","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to study definitive external beam radiation therapy together with drugs called androgen deprivation therapy (ADT) in patients with prostate cancer. The investigators want to find out if these drugs work the same way if they are given for 6 months or for the usual 18 months in patients who receive also definitive external beam radiotherapy. The investigators will also learn about the safety of the treatments. The main questions the study aims to answer are:\n\nDo patients who get radiation therapy plus 6 months of androgen deprivation therapy need other hormone therapy or develop castration resistance at a higher rate within 5 years, compared to patients who get radiation therapy plus 18 months of androgen deprivation therapy?\n\nParticipants will:\n\nBe treated with definitive external beam radiation therapy and receive androgen deprivation therapy for 6 months or 18 months.\n\nHave visits once every 3 months for checkups and tests for at least 5 years. The visits at 3 months, 1 year, and 5 years need to be done in person; all the other visits can be done in person or remotely (telehealth).\n\nKeep a diary of the missed doses of the androgen deprivation therapy.",[27],"Prostate Adenocarcinoma",[29,30,31],"Radiotherapy","Androgen deprivation therapy","Prostate cancer","NOT_YET_RECRUITING","2026-07-09",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-08",{"date":40,"type":21},"2034-04",{"name":42,"class":43},"University of California, San Diego","OTHER",1,{"id":46,"slug":4,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":44},"100578638","NCT06813898","An Investigational Scan (rhPSMA-7.3 PET\u002FCT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial","ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging","Inclusion Criteria:\n\n* Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy \\[i.e. salvage radiation\\])\n* Men must have biochemical recurrence (defined as PSA \\>= 0.1ng\u002Fml) after therapy\n* PSA \\\u003C 0.5ng\u002Fml (within 90 days of enrollment)\n* Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer\n* Non-castrate testosterone (testosterone \\[T\\] \\> 50ng\u002FdL) within 90 days of study entry\n* Institutional Review Board (IRB)-\u002FIndependent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures\n* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study\n* Concurrent diseases and malignancies are permitted\n\nExclusion Criteria:\n\n* Most recent PSA not between 0.1ng\u002Fml and 0.5ng\u002Fml\n* Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \\\u003C 50ng\u002Fdl)\n* Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)",{"count":52,"type":21},27,[54],"EARLY_PHASE1","This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET\u002FCT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET\u002FCT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET\u002FCT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.",[57,27],"Biochemically Recurrent Prostate Carcinoma","RECRUITING","2026-06-30",{"date":61,"type":36},"2026-07-02",{"date":63,"type":36},"2025-04-11",{"date":65,"type":21},"2032-02-01",{"name":67,"class":43},"Northwestern University",{"id":69,"slug":4,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":44},"100504723","NCT05852041","rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance","A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance","Inclusion Criteria:\n\n* Healthy men (Eastern Cooperative Oncology Group \\[ECOG\\] 0-1), \\>= 18 years old with at least 10 year life expectancy\n* Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate\n* Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \\>= 10 core biopsy and informed by prior mpMRI\n* Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen \\[PSA\\] \\\u003C 10ng\u002Fml, Gleason Grade Group 1 \\[Gleason 3+3=6\\] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng\u002Fml, Gleason Grade Group 2 \\[Gleason score 3+4=7\\])\n* Decipher genomic classifier score from prior biopsy \\>= 0.45\n* Institutional Review Board (IRB)-\u002FIndependent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures\n* Concurrent diseases and malignancies are permitted\n* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study\n* Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging\n\nExclusion Criteria:\n\n* Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer\n* NCCN very low risk category (T1c and Gleason Grade Group 1 \\[Gleason score 3+3=6\\], PSA \\\u003C 10 ng\u002FmL, fewer than 3 prostate biopsy cores positive, =\\\u003C 50% cancer in any core, PSA density \\\u003C 0.15 ng\u002FmL\u002Fg)\n* Decipher score \\\u003C 0.45\n* Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate \\[HoLEP\\], transurethral resection of the prostate \\[TURP\\], Urolift, Rezum)\n* Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening\n* Contra-indication or relative contra-indication to MRI (i.e., pacemaker)\n* History of hip replacement\n* Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening",true,{"count":76,"type":21},40,[54],"This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.",[27,80,81,82],"Stage I Prostate Cancer AJCC v8","Stage IIA Prostate Cancer AJCC v8","Stage IIB Prostate Cancer AJCC v8",{"date":61,"type":36},{"date":85,"type":36},"2023-06-07",{"date":87,"type":21},"2035-06-07",{"name":67,"class":43},{"id":90,"slug":4,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":44},"100640530","NCT07574489","Whole Versus Partial Gland Boost During Prostate SBRT","Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)","Inclusion Criteria:\n\n1. Adults ≥19 years of age\n2. Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered\n3. Prostate gland volume \\\u003C100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT)\n4. PI-RADS 4 or 5 lesion seen on pre-treatment MRI\n5. IPSS\u002FAUA symptom score less than 16\n\nExclusion Criteria:\n\n1. Prior treatment for prostate cancer\n2. Prior solid cancer diagnosis within the last 5 years\n3. Any history of anal or rectal cancer\n4. Any history of invasive carcinoma of the bladder\n5. History of prior circumferential resection of the rectum (such as LAR or APR)","19 Years",{"count":97,"type":21},186,[24,99],"PHASE3","This phase 2\u002F3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.",[102,27],"Prostate Cancer",[104,105,106,107,108,109,110,111,112,113,114],"Prostate SBRT","Stereotactic Body Radiotherapy","Dose Escalation","Dominant Intraprostatic Lesion","DIL","Radiation Therapy","Genitourinary Toxicity","Gastrointestinal Toxicity","CTCAE","RTOG","EPIC","2026-06-25",{"date":117,"type":36},"2026-06-29",{"date":119,"type":21},"2026-07-25",{"date":121,"type":21},"2035-08-25",{"name":123,"class":43},"University of Nebraska",{"id":125,"slug":4,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":95,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":44},"100486190","NCT05610852","Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound","Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)","Inclusion Criteria:\n\n* Subjects must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a region of interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng\u002Fml or less, Region of interest on MRI of grade 3 or greater\n* The MRI performed must include at least:\n* A T2-weighted sequence in sections ≤ 4 mm, centered on the prostate and seminal vesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence can be realized,\n* A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s \u002F mm2,\n* A dynamic sequence after gadolinium injection. It will be a sequence of echo T1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesicles in the axial plane, with or without fat saturation. A first series will be performed without contrast injection, and will be repeated iteratively for the arrival of a bolus of gadolinium chelates. The time resolution (that is to say, the acquisition time of one dynamic series will be ≤ 20 seconds). The number of chained dynamic series is calculated so that the total length of the dynamic acquisition be at least 3 minutes\n* A total dose of 0.1 mmol \u002F kg of gadolinium chelate will be injected at a rate of 3-4 mL \u002F s by using an automatic injector, in a vein of the hand of the forearm or elbow.\n* If necessary, subtracted images are calculated\n* Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core\n* Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling on each target score MRI ESUR ≥ 3\u002F5\n* Life expectancy greater than 10 years.\n* Age \\>18 years.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis\n* Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy\n* Uncorrected coagulopathy or history of Latex allergy\n* Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms\n* Poor surgical risk (defined as American Society of Anesthesiology score \\> 3).\n* Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)\n* Prostate size larger than 80 grams.\n* Subjects with prostatic Calcification (\\>0.5 cc) close to the area to be treated.\n* Subjects with extraprostatic extension or cribriform pattern on biopsy.\n* Subjectes with sexual dysfunction defined as SHIM score \\\u003C 17\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":131,"type":21},276,[133],"NA","This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.",[27,102],[137,138],"High Intensity Focused Ultrasound (HIFU)","Single-Port Transvesical Partial Prostatectomy","2026-06-24",{"date":115,"type":36},{"date":142,"type":36},"2024-01-01",{"date":144,"type":21},"2028-07-01",{"name":146,"class":43},"Case Comprehensive Cancer Center",{"id":148,"slug":4,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100511958","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",{"count":154,"type":21},1209,[99],"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.",[27,158,159],"Stage III Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","2026-06-22",{"date":115,"type":36},{"date":163,"type":36},"2023-12-14",{"date":165,"type":21},"2036-03-31",{"name":167,"class":43},"NRG Oncology",413,{"id":170,"slug":4,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100641117","NCT07635238","A Study of Lower Dose Radiation Therapy for People With Prostate Cancer","Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - A Randomized Trial (DESTINATION 2)","Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Patients must have pathologically confirmed prostate adenocarcinoma.\n* Definition of Disease\n\n  * Grade Group (GG) 1, 2, or 3.\n  * PSA less than 20 ng\u002FmL prior to starting ADT, if used.\n  * Clinical stage of TX, T1 or T2 on digital rectal examination. May have up to radiological stage T3a on MRI. MRI must be performed within 12 months of randomization.\n  * MRI-visible tumor(s), all having PIRADS v2.1 scores of 3, 4, or 5. Each tumor should be able to be delineated on T2 and diffusion-weighted imaging (DWI) +\u002F- dynamic contrast-enhanced imaging (DCE).\n  * Tumor nodule visible on MRI should be considered able to be boosted by treating clinician (ie meet urethral constraints while maintaining mandatory GTV coverage) and \\\u003C2.5cm in maximal dimension.\n  * The MRI-defined lesion must be confirmed as malignant on biopsies (Grade group 1, 2, or 3).\n  * Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. Patients needing greater than 6 months of ADT due to disease parameters should be excluded.\n  * No high grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (e.g. GG1, low volume GG2) is allowed outside of the MRI-defined area.\n  * No contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia).\n  * Prostate volume less than or equal to 90mL.\n  * No evidence of nodal or distant metastatic disease.\n* Prior Treatment\n\n  o No history of previous radiation to the prostate, prostate surgery (including transurethral resection of the prostate (TURP)), or other local prostate cancer treatments.\n* Age ≥ 18\n* ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)\n* Required Organ Function\n\n  * Adequate hematologic function defined as follows:\n\n    * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n    * Platelets ≥ 100,000 cells\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002Fdl\n  * Adequate renal function defined as follows:\n\n    * Creatinine clearance (CrCL) of ≥30 mL\u002Fmin by the Cockcroft-Gault formula:\n\nCrCl (mL\u002Fmin) = \\[140 - age (years)\\] x weight (kg) \u002F 72 x creatinine (mg \u002F dL) {x 0.85 for female patients}\n\n* Adequate hepatic function defined as follows:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)\n  * AST and ALT ≤3 x institutional ULN\n* Adequate cardiac function defined as follows:\n\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.\n  * To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).\n\n    * Comorbid Conditions\n* No active infection requiring parenteral antibiotic(s).\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* No severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.\n* No IPSS Score greater than 19.\n* No comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up.\n\n  * Ability of the participant to understand and the willingness to sign a written informed consent form.\n  * Willing to consent to contraception during and for 1 year after treatment when applicable.\n  * Ability\u002Fwillingness to comply with the patient reported outcome questionnaires schedule throughout the study.",{"count":176,"type":21},54,[24],"The purpose of this study is to see whether giving a lower (de-escalated) dose of radiation therapy to some parts of the prostate can reduce side effects compared to giving the same (uniform) dose of radiation therapy to the whole prostate.",[102,27],[102,27,181,182,183],"DESTINATION 2","Memorial Sloan Kettering Cancer Center","26-150","2026-06-17",{"date":186,"type":36},"2026-06-18",{"date":188,"type":36},"2026-05-28",{"date":190,"type":21},"2030-05-28",{"name":182,"class":43},7,{"id":194,"slug":4,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":44},"100486636","NCT05616650","Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor","A Phase II Trial of Focal Ultrahypofractionated Stereotactic Radiation Therapy for the Treatment of Unifocal Prostate Cancer","* INCLUSION CRITERIA:\n* Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required).\n* Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET\u002FCT imaging which is correlated with a positive targeted biopsy.\n* Age \\>=18 years.\n* ECOG performance status \\\u003C=2 (Karnofsky \\>60%).\n* Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study participation and up to 120 days after the last radiation treatment.\n* Ability of individual to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with NCCN high-risk prostate cancer features (Gleason score \\>=8, \\>cT2c, or PSA \\>= 20 ng\u002FmL).\n* Participants with prostate biopsies which show \\>= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are not an exclusion criterion).\n* Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.\n* Participants who are receiving any other investigational agents.\n* Participants found to have pelvic or distant metastases on pre-treatment staging studies.\n* Participants with an AUA-SI\u002FIPSS score \\> 18.\n* Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.\n* Active urinary tract infection assessed by urinalysis.\n* Human immunodeficiency virus (HIV)-infected individuals who are not on effective anti-retroviral therapy. Participants on anti-retroviral therapy with undetectable viral load within the 6 months prior to registration are eligible for this trial.\n* Participants with hepatitis B virus (HBV) infection who have not been treated and cured.\n* Participants with chronic HBV at screening must have an undetectable HBV viral load on suppressive therapy.\n* Participants with hepatitis C virus (HCV) infection who have not been treated and cured.\n* Participants with HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.\n* Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.\n* Participants with connective tissue diseases.\n* Participants with radiation hypersensitivity syndromes.\n* Ongoing active inflammatory bowel disease within the radiation field.\n* Participants with prior medical comorbidity or surgical history involving the low pelvis which is expected to confer a high risk of toxicity to the experimental radiation regimen.\n* Ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequate renal function (eGFR \\\u003C 30), severe claustrophobia, a weight above tolerance of the scanner (\\> 350 lbs.), a body size unable to fit into the scanner, or implanted devices incompatible with an MRI (implanted cardiac devices, surgical hardware, retained shrapnel, cerebral aneurysm clips, or other incompatible objects.\n* Unwillingness to undergo an 18F-DCFPyL PET\u002FCT or known allergy to the 18F-DCFPyL tracer.\n* Contraindication or inability to undergo fiducial marker implantation.\n* History of prior radiotherapy overlapping with the intended radiation field.\n* Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements.","120 Years",{"count":201,"type":21},42,[24],"Background:\n\nThe current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments.\n\nObjective:\n\nTo see how people with untreated localized prostate cancer will respond to focal therapy with SBRT.\n\nEligibility:\n\nPeople aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland).\n\nDesign:\n\n* Participants will undergo screening including blood tests, an MRI, a PSMA PET\u002FCT (18F-DCFPyL), and a biopsy.\n* Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and\u002For around the tumor to help target the radiation treatment.\n* Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards.\n* Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET\u002FCT) and blood (PSA) tests.\n* After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.",[205,102,27],"Prostatic Neoplasms",[207,208,209,27],"Sbrt","PSMA","Targeted Pet Imaging","2026-06-16",{"date":184,"type":36},{"date":213,"type":36},"2023-10-19",{"date":215,"type":21},"2031-12-01",{"name":217,"class":218},"National Cancer Institute (NCI)","NIH",{"id":220,"slug":4,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":240},"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":226,"type":21},804,[99],"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.",[57,230,27,231],"Metastatic Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8",{"date":186,"type":36},{"date":234,"type":36},"2020-10-08",{"date":236,"type":21},"2032-12-31",{"name":238,"class":239},"ECOG-ACRIN Cancer Research Group","NETWORK",342,{"id":242,"slug":4,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":253,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":44},"100641448","NCT07656337","Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness","Impact of Intra-Arterial PSMA Injection on Distribution and Tumor Uptake: Texture Analysis and Dose Radicality Prediction in Prostate Cancer","IAPSMA","Inclusion Criteria:\n\n* Adult male patients with biopsy-proven prostate adenocarcinoma up to stages ≤T3bN1 by initial preoperative examination, with no distant metastases (M0) on ⁶⁸Ga-PSMA PET\u002FCT.\n* Systemic therapy-naive patients scheduled for radical prostatectomy with\u002Fwithout pelvic lymph node dissection with curative intent.\n* High-risk localized or locally-advanced prostate cancer according to European Association of Urology criteria, including one of the following:\n\n  1. Prostate-specific antigen \\> 20ng\u002FmL2 or ISUP grade 4\u002F5.\n  2. Clinical T stage cT3-4\\* and\u002For N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries), any ISUP grade, and any\n* High PSMA avidity on ⁶⁸Ga-PSMA PET\u002FCT, defined as SUVmax ≥20.\n* Normal baseline hematological function.\n* Normal serum biochemistry.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Patients with other (non-adenocarcinoma) biopsy-proven histology of prostate cancer.\n* Patients with low-risk prostate cancer according to European Association of Urology criteria, including any of the following:\n\n  1. Prostate-specific antigen \\\u003C10 ng\u002Fml.\n  2. International Society of Urological Pathology grade group 1.\n  3. Clinical T stage T1-T2a digital rectal examination.\n* Prior radiotherapy or systemic therapy for prostate cancer.\n* Prostate cancer with low PSMA avidity (SUVmax \\\u003C20) on ⁶⁸Ga-PSMA PET\u002FCT.\n* Evidence of distant metastatic spread (M1) on ⁶⁸Ga-PSMA PET\u002FCT.\n* Contraindications for radical prostatectomy.\n* Major comorbidities and laboratory abnormalities that might confound the results of the trial or interfere with the patient's ability to participate.\n* Refusal to participate in the trial.",{"count":249,"type":21},10,[133],"The goal of this clinical trial is to learn whether intra-arterial (IA) administration of 68Ga-PSMA improves tumor uptake and distribution compared with standard intravenous (IV) administration in patients with localized high-risk prostate cancer. The study will also evaluate the safety of the IA procedure and investigate whether advanced PET\u002FCT imaging features can help predict the radiation dose needed for future personalized 177Lu-PSMA radioligand therapy.\n\nThe main questions it aims to answer are:\n\n* Does intra-arterial 68Ga-PSMA administration result in higher and more homogeneous tumor uptake than standard intravenous administration?\n* Can PET\u002FCT texture analysis and dosimetric modeling predict the radiation dose required to achieve a curative effect with 177Lu-PSMA therapy?\n* What radiation exposure and procedure-related risks are associated with intra-arterial administration for patients and medical staff?\n\nResearchers will compare PSMA uptake and distribution after intravenous and intra-arterial administration of 68Ga-PSMA using PET\u002FCT imaging.\n\nParticipants will:\n\n* Undergo a standard intravenous 68Ga-PSMA PET\u002FCT scan.\n* Undergo a second 68Ga-PSMA PET\u002FCT scan following selective intra-arterial administration through the prostatic artery.\n* Have imaging data analyzed using advanced texture analysis and voxel-based dosimetry methods.\n* Undergo radical prostatectomy according to standard clinical care, with pathological analysis of surgical specimens.\n* Be monitored for adverse events, radiation exposure, and procedural safety throughout the study.",[102,27],[31,254,255,256],"Intraarterial PSMA injection","Texture analysis","Dose radicality prediction","2026-06-15",{"date":186,"type":36},{"date":260,"type":21},"2026-08-01",{"date":262,"type":21},"2028-10-31",{"name":264,"class":43},"Lithuanian University of Health Sciences",{"id":266,"slug":4,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":44},"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":273,"type":21},202,[24],"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.",[277,231,278,279,102,27,280,281,282,283,284,285],"Recurrent Prostate Adenocarcinoma","Castration-Sensitive Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Adenocarcinoma of the Prostate","Localized Prostate Carcinoma","Metastatic Prostate Cancer","Metastatic Prostate Adenocarcinoma","Advanced Prostate Cancer","Advanced Prostate Adenocarcinoma",{"date":184,"type":36},{"date":288,"type":21},"2026-07-01",{"date":290,"type":21},"2030-12-30",{"name":292,"class":43},"Mayo Clinic",{"id":294,"slug":4,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":299,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":314,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":44},"100590480","NCT06967961","Research of Double-positive Circulating Cells (Tumor Marker \u002F CD45+) in Several Types of Metastatic Cancers","DP-PAN-CANCER","Inclusion Criteria:\n\n* 1\\. Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors\n* 2\\. Metastatic disease for which the treatment (whatever the line) has not been initiated yet\n* 3\\. Age ≥ 18 years\n* 4\\. Patient affiliated to a French Social Security scheme\n* 5\\. Patient having signed his\u002Fher informed consent prior to inclusion in the study and prior to any specific procedure for the study.\n\nExclusion Criteria:\n\n* 1\\. Patient with localized disease.\n* 2\\. Pregnant or breast-feeding women.\n* 3\\. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and\u002For procedures set out in the study protocol.\n* 4\\. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","ALL",{"count":301,"type":21},450,[133],"A prospective, proof-of-concept pilot study in patients with metastatic cancers (9 types of cancers are studied) treated at the IUCT-O or possibly in other institutions. Eligible patients will be selected and informed of this study during a medical consultation for their cancer by medical oncologists. Then, with the patient's consent and before the start of anti-cancer treatment (whatever the line), a blood sample will be taken to detect DP-circulating cells by 2 different methods of analysis.\n\nEach patient will participate in the study for one day. The methods of analysis will be: flow cytometry for all patients and either Parsotix® or CellSearch® depending on the type of cancer.\n\n450 patients will be enrolled in total.",[305,306,27,307,308,309,310,311,312,313],"Urothelial Carcinoma","Renal Cancer","Adenocarcinoma of Endometrium","Cutaneous Melanoma","Soft Tissue Sarcoma (STS)","Nonseminomatous Germ Cell Tumor","Seminomatous Germ Cell Tumor","Upper Aerodigestive Tract Carcinoma","Cervical Carcinoma",[315,316,317],"metastatic cancers","Double Positive Circulating cells","liquid biopsy","2026-06-12",{"date":257,"type":36},{"date":321,"type":36},"2025-07-23",{"date":323,"type":21},"2029-07-23",{"name":325,"class":43},"Institut Claudius Regaud",{"id":327,"slug":4,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":44},"100546235","NCT06392295","PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer","A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial","OCEAN","Inclusion Criteria:\n\n1. Histologically proven prostate adenocarcinoma\n2. Male, ≥ 18 years old\n3. Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes\n\n   * a. No more than a total of 5 lesions on PSMA PET\u002FCT scan (each lesion defined as positive with standardized uptake value (SUV) \\> liver uptake and CT scan correlate)\n   * b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes\n   * c. At least one lesion in the sub-diaphragmatic pelvic or para-aortic lymph nodes\n   * d. Non-bulky nodal disease (ie, tumor \\\u003C5 cm)\n4. Prior pelvic radiation with disease response\n\n   * a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and\u002For\n   * b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes\n5. Hormone-sensitive prostate cancer\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n7. Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s)\n8. Willingness to fill out quality of life and psychosocial forms\n9. Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)\n\nExclusion Criteria:\n\n1. No pathological diagnosis of prostate adenocarcinoma\n2. Patient has more than 5 sites of metastatic disease\n3. Patient has history of bone and\u002For visceral metastasis\n4. No evidence of disease in the para-aortic or pelvic lymph nodes\n5. No staging with PSMA PET\u002FCT scan\n6. History of prior radiation therapy outside the pelvis for prostate cancer\n7. Bulky nodal disease \\>5 cm in tumor size\n8. Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET\u002FCT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment\n9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET\u002FCT scan without confirmatory negative prostate biopsy\n10. Implanted hardware which limits treatment planning or delivery (determined by treating physician)\n11. Castration-resistant prostate cancer (history of rising PSA with serum testosterone level \\\u003C50 ng\u002FdL)\n12. Patients with ECOG performance status \\> 2\n13. History of inflammatory bowel disease\n14. History of malignancy other than prostate cancer except for non-melanoma skin cancer\n15. Patients unable to consent or are prisoners\n16. Unwilling to fill out quality of life and psychosocial forms\n17. Participants with impaired decision-making capacity",{"count":334,"type":21},34,[24],"The purpose of this prostate cancer research study is to learn about:\n\n1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;\n2. Preserving quality of life after radiation therapy;\n3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)\u002Fcomputed tomography (CT) scans to evaluate and manage disease progression.",[102,27,338],"Hormone Sensitive Prostate Cancer",[340],"Oligorecurrent Disease",{"date":210,"type":36},{"date":343,"type":36},"2024-07-03",{"date":345,"type":21},"2029-08-01",{"name":347,"class":43},"University of Miami",{"id":349,"slug":4,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":17,"minAge":354,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":359,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":44},"100447651","NCT05109208","The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction","Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction","Inclusion criteria include:\n\n* Age \\> 40 years\n* Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA \\\u003C 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer)\n* International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction)\n* Patient-expressed interest in consultation for sexual function (erectile function) preservation\u002F optimization\n* Planned bilateral nerves-paring prostatectomy\n\nExclusion criteria include:\n\n* Moderate or severe ED based in IIEF criteria (score \\\u003C 21)\n* History of prior pelvic or penile surgery\n* Current or prior androgen deprivation therapy\n* Planned non-nerve sparing prostatectomy","40 Years",{"count":249,"type":21},[133],"Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.",[27],[360],"Radical Prostatectomy","2026-06-05",{"date":363,"type":36},"2026-06-09",{"date":365,"type":36},"2023-10-02",{"date":262,"type":21},{"name":292,"class":43},{"id":369,"slug":4,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":44},"100490408","NCT05665738","Two-fraction HDR Monotherapy for Localized Prostate Cancer","Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.\n2. National Comprehensive Cancer Network low to intermediate risk stratification.\n3. No prior treatment for prostate cancer and no prior androgen deprivation therapy.\n4. Age \\>=18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2 (Karnofsky \\>60%.\n6. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.\n7. Ability to understand and the willingness to sign a written informed consent document.\n8. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n10. 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.\n11. 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.\n\nExclusion Criteria:\n\n1. Any prior treatment for prostate cancer.\n2. Any prior androgen deprivation therapy.\n3. Is currently receiving any other investigational agents.\n4. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.\n5. Contraindications to general anesthesia.\n6. Contraindications to radiotherapy.\n7. Prior cryosurgery or cryotherapy to the prostate.\n8. Prior transurethral resection of the prostate within the previous 6 months.",{"count":375,"type":21},17,[133],"This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.",[27,281],[380,29,381],"Brachytherapy","High Dose Rate","2026-06-04",{"date":361,"type":36},{"date":385,"type":36},"2024-09-11",{"date":387,"type":21},"2029-02-28",{"name":389,"class":43},"University of California, San Francisco",{"id":391,"slug":4,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":44},"100554498","NCT06499870","Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial","Optimizing Treatment and Advanced Multi-Imaging Response Evaluation for Very-High-Risk Prostate Cancer (OPTIMAL) - a Phase II Single Arm Study","Inclusion Criteria:\n\n* Patients must have histologically confirmed prostate adenocarcinoma consistent with NCCN very-high-risk (VHR) prostate cancer defined with at least one of the following:\n\n  * cT3b-cT4 (American Joint Committee on Cancer \\[AJCC\\] 9.0)\n  * \\> 4 cores with grade group 4 or 5 prostate cancer\n  * Primary gleason pattern 5\n  * 2 or 3 NCCN high-risk features.\n* Patients with involved pelvic lymph nodes below the common iliac bifurcation will be allowed as long as the criteria for VHR (very-high risk) are met\n* Patients must be age ≥ 18 years\n* Patients must have testosterone \\> 50 ng\u002FdL within 90 days prior to registration\n\n  * Note: Prior androgen deprivation (gonadotrophin releasing hormone \\[GnRH\\] analog and\u002For non-steroidal antiandrogen) therapy is allowed provided that it is less than 60 days of prior total duration and that serum testosterone concentration must be ≥ 50 ng\u002FdL prior to enrollment; 5-alpha reductase inhibitors will not impact eligibility, but must be discontinued prior to starting protocol treatment\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Leukocytes (white blood cells \\[WBC\\]) ≥ 2,500\u002FmcL\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n* Hemoglobin (Hgb) ≥ 8 g\u002FdL\n* Platelets (PLT) ≥ 80,000\u002FmcL\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) ≤ 3 x institutional upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Creatinine ≤ institutional ULN\n* Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2\n\n  * Estimated GFR (eGFR) is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation\n* For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 3 months prior to registration with a CD4 count of ≥ 200 cells\u002FμL. Note also that HIV testing is not required for eligibility for this protocol as it is self-reported\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 better than class III\n* Patients must not have contraindications to magnetic resonance (MR) imaging and be able to lie flat and still for approximately 30-40 minutes and be able to tolerate PET\u002FCT imaging and radiation therapy treatment planning and delivery\n* Patients with female partners of reproductive potential must agree to use effective contraception during treatment with and for 3 months after the last dose. Male patients must use a condom during sex with a pregnant woman\n* Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements\n\nExclusion Criteria:\n\n* Patients with definitive clinical or radiologic evidence of metastatic disease\n* Patients with prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years\n* Prior radiotherapy that would result in overlap of radiation therapy fields\n* Patients who have a history of any of the following:\n\n  * History of documented inflammatory bowel disease\n  * Symptomatic congestive heart failure (New York Heart Association Functional Classification III\u002FIV) within 4 months prior to registration\n  * Unstable angina pectoris requiring hospitalization within the last 4 months prior to registration\n  * History of seizure disorder or condition that may yield a high risk of seizure (e.g., prior cortical stroke or significant brain trauma)\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * History of repeated falls and fractures over the past 12 months that in the opinion of the treating investigator would put the patient at risk for poor bone outcomes from androgen receptor targeted therapy\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n  * Patients with the inability to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of enzalutamide and relugolix",{"count":397,"type":21},50,[24],"This phase II trial tests how well relugolix and enzalutamide, in combination with radiation therapy, works in treating patients with very high risk prostate cancer. Relugolix is a form of androgen deprivation therapy. It prevents the release of testosterone, a hormone required to sustain prostate growth. Reducing testosterone levels may inhibit the proliferation of prostate tumor cells that need testosterone to grow. Enzalutamide is an androgen receptor signaling inhibitor. It inhibits the activity of prostate tumor cell receptors, which may reduce proliferation of prostate tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Adding relugolix and enzalutamide to radiation therapy may be more effective at treating patients with very high risk prostate cancer than giving any of these treatments alone.",[27],"2026-06-03",{"date":361,"type":36},{"date":404,"type":36},"2024-09-06",{"date":406,"type":21},"2032-11-19",{"name":408,"class":43},"Sean Sachdev",{"id":410,"slug":4,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":421,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":435},"100534155","NCT06235151","Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer","Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET\u002FCT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection","Solar-Stage","Inclusion Criteria:\n\n* Patients with histologically proven prostate adenocarcinoma.\n* Planned prostatectomy with pelvic lymph node dissection.\n* Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.\n* Male aged greater than or equal to 18 years.\n* Able to understand and provide signed written informed consent.\n\nExclusion Criteria:\n\n* Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.\n* Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.\n* Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.\n* Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.\n* Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\\&T administration.\n* Patients with known hypersensitivity to the active substance or any of the excipients of the IP.\n* Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.",{"count":417,"type":21},439,[99],"This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\\&T injection for PET\u002FCT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.",[102,27],[208,102,422,414,423,424,425],"Initial Staging","Cu-64 PSMA","PET","Solar","2026-06-02",{"date":382,"type":36},{"date":429,"type":36},"2024-04-01",{"date":431,"type":21},"2026-09",{"name":433,"class":434},"Curium US LLC","INDUSTRY",44,{"id":437,"slug":4,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":457},"100348780","NCT03821246","Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy","An Open-Label Multi-Center Phase II Study of Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the prostate.\n\n   a. Subjects with small cell or neuroendocrine PC are not eligible.\n2. Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy.\n\n   a. Deemed by urologic oncology surgeon to be appropriate for a \"window-of-opportunity\"study.\n3. Only patients with high-risk disease are eligible for the safety lead-in for each cohort. Patients with intermediate-risk disease will be included after interim analyses is complete for the corresponding cohort and the PI has determined that it is safe to do so.\n4. Availability of a representative tumor specimen that is suitable for the planned study analyses, as determined by the Principal Investigator.\n\n   1. A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study treatment. If only 10-14 slides are available, the patient may still be eligible for the study, after Principal Investigator approval has been obtained.\n   2. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Refer to Section 6.3 for additional information on tumor specimens collected at screening.\n5. Subjects have not received any prior systemic or locally directed therapy for PC (see exclusion criteria).\n6. Age \\>= 18 years\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n8. Requirements for organ and marrow function:\n\n   * Hemoglobin \\>= 9 g\u002FdL\n   * \\- Participants must not have been transfused within 2 weeks prior to screening to meet this criterion\n   * Absolute neutrophil count \\>= 1,500\u002Fmicroliter (uL) without granulocyte colonystimulating factor support\n   * Absolute lymphocyte count \\>= 500\u002FuL\n   * Platelets \\>= 100,000\u002FuL without transfusion\n   * Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (known Gilbert disease: \\\u003C 3 x ULN)\n   * Alkaline phosphatase \\\u003C 2 x institutional ULN\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =\\\u003C 2 x institutional ULN\n   * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =\\\u003C 2 x institutional ULN\n   * International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\\u003C 1.5 x institutional ULN for subjects not receiving therapeutic anticoagulation\n   * Creatinine clearance \\>= 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Serum creatinine \\\u003C=1.6 mg\u002FdL (141 μmol\u002FL) in female patients and ≤1.9 mg\u002FdL (168 μmol\u002FL) in male patients . Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are \\>30\n9. Testosterone level \\> 150 ng\u002FdL.\n10. Contraception: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm as defined below:\n\n    1. With female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 4 months after the last dose of study treatment. Men must refrain from donating sperm during the same period\n    2. With pregnant female partners: men must remain abstinent or use a condom during the treatment period and for 4 months after the last dose of study treatment to avoid exposing the embryo\n    3. Abstinence: the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen \\> 3 months.\n12. Ability to understand a written informed consent document, and the willingness to sign it.\n13. Ability to comply with the study protocol, in the investigator's judgment.\n\nExclusion Criteria:\n\n1. Evidence of metastatic disease as determined by standard staging scans.\n\n   a. Staging scans should be performed per urologic standard of care for patients undergoing radical prostatectomy \\[per American Urological Association (AUA)\u002FNational Comprehensive Cancer Network (NCCN) guidelines\\].\n2. Not a candidate for radical prostatectomy as determined by treating urologic oncology surgeon.\n3. Any prior systemic therapy for PC, including antiandrogens, androgen deprivation therapy \\[gonadotropin-releasing hormone (GnRH) agonist or antagonist\\], chemotherapy, targeted therapy, immunotherapy, OR radiopharmaceuticals.\n\n   a. Subjects who are on finasteride or dutasteride must discontinue therapy and undergo a washout period of 6 weeks to become eligible for the study. Screening procedures should begin following the washout period.\n4. Prior radiotherapy for PC.\n5. Any history of prior malignancy, except:\n\n   1. Non-melanoma skin cancer treated with curative intent\n   2. Carcinoma-in-situ (CIS) treated with curative intent, without evidence of recurrence or disease progression for 3 years\n   3. Appropriately treated Stage I uterine cancer\n   4. All other cancer: treated with curative intent and without evidence of disease on standard of care follow-up for 5 years\n6. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n   1. Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement therapy, with a stable dose \\> 3 months, are eligible for the study\n   2. Subjects with controlled type 1 diabetes mellitus who are on an insulin regimen, with a Glycated hemoglobin (hemoglobin A1C) \\\u003C 7.0 are eligible for the study. All subjects with controlled type 2 diabetes mellitus are eligible for the study\n   3. Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded from the study) are eligible for the study provided all of the following conditions are met:\n\n      * Rash covers \\\u003C 10% of body surface area\n      * Disease is well controlled at baseline and requires only low-potency topical steroids\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\n7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or any evidence of active, non-infectious pneumonitis requiring corticosteroids.\n8. History of prior positive human immunodeficiency virus (HIV) test.\n9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (chronic or acute).\n\n   1. Subjects with a past or resolved HBV infection are eligible for this study.\n   2. HCV positivity is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening; the HCV RNA test will only be performed for subjects who have a positive HCV antibody test.\n10. Significant cardiovascular disease, such as New York Heart Association class III or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n11. Active chronic obstructive pulmonary disease (COPD) requiring use of home oxygen (O2) or systemic steroid therapy \\> 10 mg prednisone (or equivalent) daily.\n12. Asthma requiring systemic corticosteroids \\> 10 mg prednisone (or equivalent) daily. Inhaled corticosteroids for the treatment of asthma are permitted.\n13. Major surgical procedure (including joint surgery) other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study.\n\n    a. Placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted.\n14. 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.\n15. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n16. Prior allogeneic stem cell or solid organ transplantation.\n17. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of atezolizumab. Note: Because IL-6 inhibition may interfere with the normal immune response to new antigen, patients should be brought up to date on all recommended vaccinations, except for live vaccines, prior to initiation of therapy with tocilizumab to maximize vaccine response.\n18. Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n19. Prior treatment with adenosine-axis inhibitors, cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), ant-PD-1, and anti-PD-L1 therapeutic antibodies.\n20. Treatment with systemic immunostimulatory agents \\[including, but not limited to, interferon and interleukin 2 (IL-2)\\] within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment.\n21. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions:\n\n    1. Patients who receive 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\n    2. Patients who receive mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma (=\\\u003C 10 mg prednisone or equivalent), or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency (=\\\u003C 10 mg prednisone or equivalent) are eligible for the study.\n22. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n23. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.\n24. Known allergy or hypersensitivity to any of the study drugs of their excipients.\n25. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-cluster of differentiation 4 (CD4), anti-cluster of differentiation 5 (CD5), anti-cluster of differentiation 3 (CD3), anti-Cluster of Differentiation 19 (CD19) and anti-Cluster of Differentiation 20 (CD20) within 5 years prior to first dose of study treatment.\n26. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.\n27. Previous treatment with tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the Sponsor-Investigator on a case-by-case basis).\n28. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation within 5 years prior to first dose of study treatment.\n29. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.\n30. Evidence of serious uncontrolled concomitant, nervous system, pulmonary, renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease).\n31. Any history of recent serious bacterial, viral, fungal, or other opportunistic infections.\n32. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.\n33. Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial.\n34. Pregnant women or nursing (breast feeding) mothers.\n35. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation.\n36. Patients with lack of peripheral venous access\n\n    Additional Exclusion Criteria for Cohort B (atezolizumab + etrumadenant):\n37. Treatment with known P-glycoprotein (P-gp) substrates with a narrow therapeutic window, administered orally (e.g., digoxin) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n38. Treatment with known strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) and strong CYP3A4 inhibitors (eg,clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin,and voriconazole) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n39. Treatment with known breast cancer resistance protein (BCRP) substrates with a narrow therapeutic window, administered orally (e.g., prazosin, rosuvastatin) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n\n    Additional Exclusion Criteria for Cohort C (atezolizumab + tocilizumab):\n40. Known active infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including, but not limited to, TB (i.e., has signs and symptoms of TB) and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds.",{"count":443,"type":21},68,[24],"This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. 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. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer.",[27,102,447],"Localized Prostate Cancer",[449],"Neoadjuvant therapy",{"date":382,"type":36},{"date":452,"type":36},"2019-10-30",{"date":454,"type":21},"2027-04-30",{"name":456,"class":43},"David Oh",2,{"id":459,"slug":4,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":465,"briefSummary":466,"conditions":467,"keywords":468,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100635398","NCT07552168","INSPIRE: INnovative SABR for Prostate Cancer All IREland","Inclusion Criteria:\n\n1. Written informed consent obtained prior to any study-related procedures\n2. Males ≥ 18 years of age\n3. ECOG performance status (PS) 0-2\n4. Biopsy-proven prostate adenocarcinoma without neuro-endocrine differentiation (within 18 months prior to registration, unless on active surveillance and re-biopsy not clinically indicated)\n5. Gleason score ≤ 4+3\n6. Clinical and\u002For MRI stage T1c-T3a, N0-X, M0-X\n7. PSA ≤ 30 ng\u002Fml (within 60 days prior to registration \u002F prior to starting androgen-deprivation therapy (ADT\u002Fhormone therapy) \\[PSA ≤ 15 ng\u002Fml for patients on 5-alpha reductase inhibitors\\]\n8. Patients belonging to one of the following risk groups:\n\n   * Low risk - patients meeting all of the following criteria:\n\n     * Gleason ≤ 6\n     * Clinical stage T1c-T2a\n     * PSA \\\u003C 10 ng\u002Fml (within 60 days prior to registration)\n   * Intermediate risk - patients meeting any of the following criteria, assuming no high-risk features apply:\n\n     * Gleason 7 (3+4 or 4+3)\n     * MRI stage T2b-T2c (N0, M0-X)\n     * PSA 10-20 ng\u002Fml (within 60 days prior to registration)\n   * High risk - patients with tumours that meet a maximum of one of the following criteria:\n\n     * MRI stage T3a (N0, M0)\n     * PSA \\>20 - ≤30 ng\u002Fml (within 60 days prior to registration)\n\nExclusion Criteria:\n\n1. Previous malignancy within the last 2 years (except basal cell carcinoma (BCC) or squamous carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival\n2. Prior pelvic radiotherapy\n3. Any prior active treatment for prostate cancer (with the exception of ADT). Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.\n4. Life expectancy \\\u003C5 years.\n5. Bilateral hip prostheses or any other implants\u002Fhardware that would introduce substantial CT artefacts\n6. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.\n7. Anticoagulation with warfarin\u002Fbleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician. Note: Anti-platelet agents e.g. aspirin, clopidogrel and DOACs such as apixaban, rivaroxaban are not contraindications to trial entry.\n8. Participation in another concurrent treatment protocol for prostate cancer (not including QoL, survivorship, exercise or registry studies).",{"count":464,"type":21},136,[24],"This is a Phase II, single arm, multi-centre, prospective clinical trial evaluating next generation Stereotactic Ablative Radiotherapy (SABR) for low, intermediate, and eligible high-risk prostate cancer. Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies",[27],[469,31,470,471,472,473],"SABR","Prostate adenocarcinoma","Low-risk prostate cancer","Intermediate-risk prostate cancer","High-risk prostate cancer",{"date":475,"type":36},"2026-06-01",{"date":477,"type":21},"2026-04",{"date":479,"type":21},"2034-11",{"name":481,"class":239},"Cancer Trials Ireland",3,{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":17,"minAge":490,"maxAge":491,"enrollmentInfo":492,"targetDuration":494,"studyType":495,"phases":4,"briefSummary":496,"conditions":497,"keywords":498,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":514},"100510821","NCT05931419","High-Risk prostatE Cancer radiatiOn Versus surgERy","High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)","RECOVER","Inclusion Criteria:\n\n* Histologically confirmed de novo non-metastatic high-risk prostate cancer.\n* cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and\u002For\n* International Society of Urological Pathology (ISUP) grade ≥4 and\u002For\n* Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng\u002FmL\n* Fit for treatment with either RARP or EBRT +\u002F- ADT (WHO performance status 0-1)\n* Living in the Netherlands\n* Able to read and understand the Dutch language\n\nExclusion Criteria:\n\n* Histological types other than adenocarcinoma\n* Diagnosis and\u002For treatment in a hospital abroad\n* Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan","50 Years","75 Years",{"count":493,"type":21},837,"5 Years","OBSERVATIONAL","Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy +\u002F- androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.",[102,27],[499,29,500,501,502,503,504],"Radical prostatectomy","Health-related quality of life","Functional outcomes","Progression-free survival","Distant metastases-free survival","Cost-effectiveness","2026-05-21",{"date":507,"type":36},"2026-05-22",{"date":509,"type":36},"2023-02-16",{"date":511,"type":21},"2030-06-30",{"name":513,"class":43},"Comprehensive Cancer Centre The Netherlands",28,{"id":516,"slug":4,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":17,"minAge":354,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":44},"100628996","NCT07468903","Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer","Phase II Trial of Focal Radiation Therapy in Patients With Prostate Cancer","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy\n* Multiparametric MRI (mp-MRI) confirmed lesion(s)\n* No distant or locally advanced disease on standard staging exams as indicated\n\n  * Bone scan and abdominopelvic computed tomography (CT)\u002FMRI OR\n  * PSMA PET\n* Eastern Cooperative Oncology Group (ECOG)\u002FZubrod performance status 0\u002F1 within 60 days prior to enrollment\n* Age ≥ 40\n\nExclusion Criteria:\n\n* Radiographic nodal or distant metastatic disease\n* Lesion(s) comprising \\> 40% of total prostate volume\n* Prior radiotherapy to the pelvis\n* Gleason score \\> 6 disease outside intended gross target volume (GTV)\u002Ftarget region(s)",{"count":522,"type":21},45,[133],"This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.",[27,526,527],"Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage II Prostate Cancer AJCC v8","2026-05-19",{"date":507,"type":36},{"date":531,"type":36},"2026-05-11",{"date":533,"type":21},"2032-05-11",{"name":535,"class":43},"Jonsson Comprehensive Cancer Center",{"id":537,"slug":4,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":44},"100357410","NCT03933670","Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance","A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance","Inclusion Criteria:\n\n* The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.\n* For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate\u002FmpMRI on study.\n* The subject is able and willing to comply with study procedures and provide signed and dated informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Absolute neutrophil count (ANC) \\>= 1000 cells\u002Fmicroliter (uL).\n* Hemoglobin \\>= 9.0 gm\u002Fdeciliter (dL).\n* Platelets \\>= 75,000 cells\u002FuL.\n* Estimated creatinine clearance\\* \\>= 50 milliliter (mL)\u002Fmin by the Cockcroft Gault equation.\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) or if =\\\u003C 3 x ULN if known\u002Fsuspected Gilbert's\n* Aspartate aminotransferase (AST) =\\\u003C 1.5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 1.5 x ULN.\n\nExclusion Criteria:\n\n* Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.\n* Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI\n* Prior radiation treatment of the prostate.\n* Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.\n* Poorly controlled hypertension, with blood pressure at study entry \\> 160 mm Hg systolic or \\> 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.\n* Congestive heart failure with New York Heart Association (NYHA) status \\>= 2.",{"count":543,"type":21},60,[24],"This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.",[27,102],[548],"Imaging","2026-05-14",{"date":551,"type":36},"2026-05-18",{"date":553,"type":36},"2018-07-18",{"date":555,"type":21},"2028-06-30",{"name":389,"class":43},{"id":558,"slug":4,"hasResults":11,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":576},"100517844","NCT06022822","Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial","A Phase 2 Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy","Inclusion Criteria:\n\n* Participants who have pathologically confirmed adenocarcinoma of the prostate with formalin-fixed paraffin embedded (FFPE) biopsy tissue available for analysis, including those on active surveillance. Most recent biopsy can be any time in the six months prior to registration\u002Frandomization\n* Participants \\>= 18 years will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of urolithin A in participants \\\u003C 18 years of age, children and adolescents are excluded from this study\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants 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* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* Scheduled to undergo RP in the next 3-6 weeks\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with prior primary treatment or hormonal therapy for prostate cancer (PC)\n* Participants with documented active alcohol and illegal substance dependency\n* Participants already receiving urolithin A (Mitopure, commercially available in the United States), or pomegranate supplements. Note: Other supplements are allowed but must be documented\n* Participants receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to urolithin A\n* Uncontrolled intercurrent illness, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":564,"type":21},90,[24],"This phase II randomized control trial assesses the effect of Urolithin A (Uro-A) supplementation compared to placebo in men with biopsy-confirmed prostate cancer undergoing radical prostatectomy (RP) progressive disease. A total of 90 men will be accrued and randomized 1:1 to receive a 1000 mg daily dose of Uro-A in two 250 mg capsules PO BID or two placebo capsules BID daily for 3 to 6 weeks prior to RP. The primary endpoint is to determine the effect of Uro-A on decreasing prostate tumor tissue oxidative stress (measured by 8-OHdG) compared to placebo.",[27],"2026-05-12",{"date":570,"type":36},"2026-05-13",{"date":572,"type":36},"2024-09-12",{"date":574,"type":21},"2027-05-01",{"name":217,"class":218},5,{"id":578,"slug":4,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":584,"briefSummary":585,"conditions":586,"keywords":587,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":482},"100503194","NCT05832086","Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes","Inclusion Criteria:\n\n* Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)\n* Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy\n* Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Allergies to any ingredients listed on the Xentigen Ingredient List\n* Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD\n* Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation\n* Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol\u002Fdrug abuse) that in the opinion of the study physician would preclude enrollment in this study.\n* Body Mass Index (BMI) \\\u003C20kg\u002Fm2\n* Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months\n* Self-reported weight loss ≥ 10% in the last 6 months",{"count":583,"type":21},138,[24],"This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.\n\nThis study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.",[27],[588],"Fasting","2026-05-02",{"date":591,"type":36},"2026-05-06",{"date":593,"type":36},"2023-09-13",{"date":595,"type":21},"2029-03-30",{"name":597,"class":43},"Stephen Freedland",{"id":599,"slug":4,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":44},"100353326","NCT03880422","Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer","Inclusion Criteria:\n\n* Biopsy-confirmed prostate adenocarcinoma of any stage\u002Fgrade\n* Prescribed or already receiving continuous ADT for \\\u003C 5 years\n* Hemoglobin \\> 11 g\u002FdL\n* Creatinine \\\u003C 1.5 x upper limit of normal (ULN), AST or ALT \\\u003C2 x ULN within 6 months prior to enrollment\n* Liver function tests \\\u003C 2 x ULN\n* Able to walk unassisted at least 100 meters (200 steps) or ECOG \\\u003C= 1\n* No contraindications to any aspect of participation, including aerobic exercise\n* Participant must be able to read, write, and understand the English language and be able to provide written consent\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* Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and\u002For significant cardiac arrhythmias\n* Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)\n* Overall medical frailty (clinician discretion)\n* Any condition contraindicating additional blood collection beyond standard of care\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 intervention",{"count":397,"type":21},[133],"This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.",[607,608,609,27,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625],"Cancer Survivor","Obesity","Overweight","Stage A Prostate Cancer","Stage B Prostate Cancer","Stage C Prostate Cancer","Stage D Prostate Cancer","Stage I Prostate Cancer","Stage II Prostate Cancer","Stage IIA Prostate Cancer","Stage IIB Prostate Cancer","Stage IIC Prostate Cancer","Stage III Prostate Cancer","Stage IIIA Prostate Cancer","Stage IIIB Prostate Cancer","Stage IIIC Prostate Cancer","Stage IV Prostate Cancer","Stage IVA Prostate Cancer","Stage IVB Prostate Cancer","2026-05-01",{"date":628,"type":36},"2026-05-07",{"date":630,"type":36},"2019-05-02",{"date":632,"type":21},"2029-05-02",{"name":634,"class":43},"Roswell Park Cancer Institute",""]