[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,49,76,118,143,166,190,215,239,267,289,316,343,364,385,407,441,462,487,516,539,573,597,617,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100435087","high-dose-rate-brachytherapy-and-stereotactic-body-radiotherapy-for-the-treatment-of-prostate-adenocarcinoma-100435087",false,"NCT04945642","High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma","Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)","HYDRA","Inclusion Criteria:\n\n* Ability to understand a written informed consent document, and the willingness to sign it\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* History\u002Fphysical examination with digital rectal examination of the prostate within 8 weeks prior to registration\n* Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \\> 10, and\u002For Gleason score \\>= 7\n* No evidence of disease beyond the prostate and\u002For seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)\n* Prostate size =\\\u003C 60cc\n* International Prognostic Scoring System (IPSS) score =\\\u003C 15\n* Able to safely receive moderate sedation or general anesthesia\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous\u002Fhematogenous malignancy unless continually disease free for a minimum of 5 years\n* Regional lymph node involvement\n* Evidence of distant metastases\n* Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer\n* Previous pelvic irradiation or prostate brachytherapy\n* Previous or concurrent cytotoxic chemotherapy for prostate cancer\n* Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery\n* Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment","MALE","18 Years",{"count":21,"type":22},52,"ESTIMATED","INTERVENTIONAL",[25],"NA","This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.",[28,29,30,31,32,33,34,35],"Prostate Adenocarcinoma","Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","RECRUITING","2026-08-18",{"date":39,"type":40},"2026-08-20","ACTUAL",{"date":42,"type":40},"2021-08-20",{"date":44,"type":22},"2028-07-01",{"name":46,"class":47},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100394987","phase-3-treating-prostate-cancer-that-has-come-back-after-surgery-with-apalutamide-and-targeted-radiation-based-on-pet-imaging-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":57,"type":22},804,[59],"PHASE3","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.",[62,63,28,64],"Biochemically Recurrent Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8","2026-08-17",{"date":67,"type":40},"2026-08-19",{"date":69,"type":40},"2020-10-08",{"date":71,"type":22},"2032-12-31",{"name":73,"class":74},"ECOG-ACRIN Cancer Research Group","NETWORK",341,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":109,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":48},"100589690","phase-2-proof-of-concept-trial-to-assess-the-efficacy-and-safety-of-fezolinetant-in-improving-vasomotor-symptoms-in-men-with-prostate-cancer-undergoing-androgen-deprivation-therapy-100589690","NCT06957691","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)","Fezo-ADT","Inclusion Criteria:\n\n* Male sex\n* Age 40 years and older\n* Diagnosis of prostate cancer\n* Androgen deprivation therapy\n* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week\n* Ability to sign the inform consent\n* Willing to use reliable methods of contraception if partner is of childbearing age\n* Ability to record hot flashes electronically\n\nExclusion Criteria:\n\n* Use of abiraterone acetate\n* Use of docetaxel and other chemotherapeutic agents\n* Liver cirrhosis\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal\n* Total bilirubin above the upper limit of normal\n* Glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics if prescribed for the treatment of hot flashes\n* Use of over-the-counter hormonal agents or herbal compounds\n* Current use of CYP1A2 inhibitors\n* Ingestion of alcohol within 2 weeks prior to the baseline visit\n* Inability to abstain from alcohol use during the study period.","40 Years",{"count":86,"type":22},60,[88],"PHASE2","The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.\n\nThe main questions it aims to answer are:\n\n* Does fezolinetant improve the frequency and severity of hot flashes?\n* Does fezolinetant cause any harm to the liver?\n* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?\n\nResearchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.\n\nParticipants will:\n\n* Take fezolinetant or a placebo every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of the number of times and intensity that they experience hot flashes",[91,92,93,94,95,96,28,97,98,99,100,101,102,103,104,105,106,107,108],"Prostate Cancer","Prostate Cancer (Adenocarcinoma)","Prostate Cancer Metastatic Disease","Prostate Cancer Recurrent","Prostate Carcinoma","Prostate Neoplasm","Prostate Cancer With Bone Metastasis","Vasomotor Disturbance","Vasomotor Symptoms","Vasomotor Symptoms (VMS)","Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","Vasomotor Symptoms; Hot Flashes","Androgen Deprivation Therapy","Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma","Androgen-deprivation Therapy","Hot Flashes","Hot Flushes","Hot Flushes and\u002For Sweats",[103,106,107,91,99],"2026-08-13",{"date":65,"type":40},{"date":113,"type":40},"2026-01-14",{"date":115,"type":22},"2028-12-31",{"name":117,"class":47},"Shehzad Basaria, M.D.",{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":142},"100535889","phase-1-enzalutamide-implants-enolen-in-patients-with-prostate-cancer-100535889","NCT06257693","Enzalutamide Implants (Enolen) in Patients With Prostate Cancer","A Phase 1 Study to Establish the Feasibility of Enolen (tm) for the Local Delivery of Enzalutamide in Patients With Prostate Cancer","Inclusion Criteria:\n\n1. Age at least 21 years old\n2. Histologically confirmed adenocarcinoma of the prostate\n3. Study participant qualified and planning for radical prostatectomy\n4. At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm\n5. Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4\n6. Study participant must be willing to undergo post-treatment imaging by MRI\n7. Participants must be able to understand and sign the informed consent form\n8. ECOG performance status 0 or 1\n9. Adequate organ function, including absolute neutrophil count (ANC) ≥1000 cells\u002FμL, hemoglobin ≥9 g\u002FdL, platelets ≥100,000 cells\u002FμL, estimated creatinine clearance ≥50 mL\u002Fmin, bilirubin \\\u003C1.5x ULN (\\\u003C 3x ULN for documented Gilbert's syndrome)\n10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \\\u003C2.5x ULN\n11. The effects of Enolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and continuing through three months after radical prostatectomy\u002Fimplant removal. Highly effective forms of contraception include:\n\nVasectomy Condom with spermicide\n\nPartner use of one of the following methods:\n\nPostmenopausal \\>1 year or age \\>55y Bilateral tubal ligation Intrauterine devices (IUDs) Hormonal implants (Implanon, Nexplanon, etc.) Combination oral contraceptives Progestin-only injections (Depo-Provera) Hormonal patches Vaginal Ring Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately.\n\nExclusion Criteria:\n\n1. Prior radiotherapy or surgery for prostate cancer\n2. Ongoing hormonal therapy for prostate cancer or hormone therapy \\\u003C3 months prior to the start of treatment\n3. Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive Benign Prostate Hyperplasia (BPH) procedure\n4. Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.\n5. Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.\n6. Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.\n7. Presence of any metastatic disease.\n8. No evidence of extracapsular extension of disease.\n9. Study participants, who in the opinion of the treating clinician, would be at increased risk of refractory urinary retention due to a transperineal procedure such as the Enolen implant.\n10. History of prostate infection within 2 years.\n11. No intercurrent medical condition or circumstances that would preclude prostatectomy.\n12. History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.\n13. Any condition that, in the opinion of the Principal Investigator, which would impair the participant's ability to comply with study procedures and undergo prostatectomy.","21 Years",{"count":127,"type":22},45,[129],"PHASE1","The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.",[28],"2026-08-07",{"date":134,"type":40},"2026-08-11",{"date":136,"type":40},"2024-06-21",{"date":138,"type":22},"2028-12-30",{"name":140,"class":141},"Alessa Therapeutics Inc.","INDUSTRY",10,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100503194","intermittent-fasting-using-a-fasting-mimicking-diet-to-improve-prostate-cancer-control-and-metabolic-outcomes-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":150,"type":22},138,[88],"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.",[28],[155],"Fasting","2026-08-06",{"date":158,"type":40},"2026-08-10",{"date":160,"type":40},"2023-09-13",{"date":162,"type":22},"2029-03-30",{"name":164,"class":47},"Stephen Freedland",3,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":18,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":48},"100486190","single-port-transvesical-partial-prostatectomy-versus-high-intensity-focused-ultrasound-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.","19 Years",{"count":175,"type":22},276,[25],"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.",[28,91],[180,181],"High Intensity Focused Ultrasound (HIFU)","Single-Port Transvesical Partial Prostatectomy","2026-08-04",{"date":156,"type":40},{"date":185,"type":40},"2024-01-01",{"date":187,"type":22},"2028-12-01",{"name":189,"class":47},"Case Comprehensive Cancer Center",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":48},"100620934","phase-2-strategic-endocrine-therapy-and-targeted-radiotherapy-for-prostate-cancer-100620934","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.",{"count":199,"type":22},150,[88],"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.",[28],[204,205,206],"Radiotherapy","Androgen deprivation therapy","Prostate cancer","2026-07-31",{"date":182,"type":40},{"date":210,"type":40},"2026-07-20",{"date":212,"type":22},"2034-04",{"name":214,"class":47},"University of California, San Diego",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":142},"100496991","phase-2-a-study-on-the-effects-of-exercise-therapy-on-signs-of-prostate-cancer-100496991","NCT05751434","A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer","Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer","Inclusion Criteria:\n\n* Age ≥ 18\n* Men with histologically confirmed localized prostate cancer undergoing active surveillance.\n* Inactive, defined as not meeting the national exercise guidelines for cancer patients (\\\u003C150 minutes\u002Fweek of moderate or vigorous exercise)43 as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch).\n* Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG)\n* BMI \\\u003C40 kg\u002Fm\\^2\n* Cleared for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (Appendix B)\n\nExclusion Criteria:\n\n* Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)\n* Any neoadjuvant anticancer treatment of any kind for prostate cancer in the last 5 years\n* Any history of systemic anticancer therapy in the last 15 years\n* Distant metastatic malignancy of any kind\n* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation",{"count":223,"type":22},102,[88],"To determine the effects of exercise therapy on molecular, radiologic, and pathologic nimbosus hallmarks versus usual care control in men on Active Surveillance for localized prostate cancer.",[91,28,227],"Localized Prostate Carcinoma",[91,28,227,229],"exercise therapy","2026-07-29",{"date":232,"type":40},"2026-07-30",{"date":234,"type":40},"2023-02-10",{"date":236,"type":22},"2028-06-01",{"name":238,"class":47},"City of Hope Medical Center",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":48},"100534429","extraperitoneal-single-port-robotic-assisted-radical-prostatectomy-rarp-versus-transperitoneal-multi-port-rarp-in-the-treatment-of-prostate-cancer-sino-top-100534429","NCT06238713","Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)","Inclusion Criteria:\n\n1. Men aged 18 years ≤ age ≤ 75 years;\n2. Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.\n3. Gleason Score\\\u003C8.\n4. PSA\\\u003C20ng\u002Fml.\n5. Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;\n6. The patient has healthy sexual function before surgery and intention for sexual activities after surgery;\n7. Physiological condition acceptable for laparoscopic surgery;\n8. Willing to cooperate and complete the study follow-up and related examinations;\n9. The subject or his agent voluntarily participates in this trial and signs the written informed consent;\n10. The questionnaire can be completed in Chinese.\n11. The patient has been informed of the trial;\n\nExclusion Criteria:\n\n1. High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA \\> 20ng\u002Fml);\n2. Special type of prostate cancer， such as neuroendocrine etc.;\n3. History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;\n4. Recent surgery of rectum, perianal abscess or around fistula and perineal area;\n5. Patients who have undergone previous electro-prostatectomy\u002Fenucleation of the prostate;\n6. Non-recurrent patients with less than 12 months of follow-up;\n7. ECOG\\>1.\n8. Combination of other systemic tumors;\n9. had received any type of preoperative antitumor therapy;\n10. Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function;\n11. Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;\n12. Other conditions that the researchers believe may affect the experimental results or are unethical;","75 Years",{"count":247,"type":22},480,[25],"This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.",[28,227],[91,252,253,254,255,256,257],"Robotic-assisted Radical Prostatectomy","da Vinci surgical robot","Potency","Non-inferiority","RCT","Continence","2026-07-22",{"date":260,"type":40},"2026-07-23",{"date":262,"type":40},"2024-01-08",{"date":264,"type":22},"2028-12",{"name":266,"class":47},"Shanghai Changzheng Hospital",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":48},"100521259","phase-2-hormone-therapy-apalutamide-and-image-guided-stereotactic-body-radiation-therapy-for-the-treatment-of-patients-with-prostate-cancer-heatwave-trial-100521259","NCT06067269","Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial","High Precision Stereotactic Radiotherapy to the Whole Prostate With Focal Boost and Varying Hormonal Therapy (HEATWAVE)","HEATWAVE","Inclusion Criteria:\n\n* Confirmed diagnosis of prostate adenocarcinoma\n* Age ≥ 18\n* Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \\[a\\] 2 of the following: PSA 10-20 ng\u002FmL, clinical T category 2b-2c, or International Society of Urological Pathology \\[ISUP\\] grade group 2; \\[b\\] OR any 1 of \\[a\\] with ISUP grade group 3 disease; OR \\[c\\] any 1 of \\[a\\] with 50% or more cores on systematic biopsy showing prostate cancer)\n* Have a Decipher genomic classifier score\n* Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \\[PI-RADS\\] version 2.1 score 4 or 5)\n* Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography\u002Fcomputed tomography (PET\u002FCT)\n* Have total testosterone \\>= 150 ng\u002FdL\n* Adequate performance status (Eastern Cooperative Oncology Group \\[ECOG\\] 0-1)\n* Hemoglobin ≥ 9.0 g\u002FdL, independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Platelet count ≥ 100,000 x 10\\^9\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Serum albumin ≥ 3.0 g\u002FdL (at screening)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin (at screening)\n* Serum potassium ≥ 3.5 mmol\u002FL (at screening)\n* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 2.5 x ULN (at screening)\n* Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry\n\nExclusion Criteria:\n\n* Any evidence of spinal cord compression (radiological or clinical)\n* Prior pelvic malignancy\n* Prior pelvic radiation\n* Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression\n* Inability to undergo radiotherapy, or hormonal therapy\n* Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)\n* Inflammatory bowel disease or active collagen vascular disease\n* History of any of the following:\n\n  * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \\[CNS\\] or meningeal disease which may require treatment with surgery or radiation therapy)\n  * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization\n* Current evidence of any of the following:\n\n  * Uncontrolled hypertension\n  * Gastrointestinal disorder affecting absorption\n  * Known active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n  * Any condition that in the opinion of the investigator would preclude participation in this study\n  * Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered\n  * Baseline moderate and severe hepatic impairment (Child Pugh class B \\& C)",{"count":276,"type":22},95,[88],"This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. 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 and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.",[28,280,32,33],"Stage II Prostate Cancer AJCC v8","2026-07-16",{"date":283,"type":40},"2026-07-17",{"date":285,"type":40},"2024-03-28",{"date":287,"type":22},"2027-12-30",{"name":46,"class":47},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":48},"100486636","phase-2-focal-therapy-with-stereotactic-body-radiation-therapy-sbrt-for-patients-with-a-single-prostate-tumor-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":298,"type":22},42,[88],"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.",[302,91,28],"Prostatic Neoplasms",[304,305,306,28],"Sbrt","PSMA","Targeted Pet Imaging","2026-07-15",{"date":281,"type":40},{"date":310,"type":40},"2023-10-19",{"date":312,"type":22},"2031-12-01",{"name":314,"class":315},"National Cancer Institute (NCI)","NIH",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":23,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100635398","phase-2-inspire-innovative-sabr-for-prostate-cancer-all-ireland-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":323,"type":22},136,[88],"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",[28],[328,206,329,330,331,332],"SABR","Prostate adenocarcinoma","Low-risk prostate cancer","Intermediate-risk prostate cancer","High-risk prostate cancer","2026-07-02",{"date":335,"type":40},"2026-07-06",{"date":337,"type":40},"2026-04-23",{"date":339,"type":22},"2034-11",{"name":341,"class":74},"Cancer Trials Ireland",4,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":363},"100375970","phase-2-prostate-specific-membrane-antigen-psma-or-facbc-petct-site-directed-therapy-for-treatment-of-prostate-cancer-flu-blast-pc-study-100375970","NCT04175431","Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET\u002FCT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study","Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET\u002FCT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study","Inclusion Criteria:\n\n* Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma\n* Patient must previously have undergone radical prostatectomy\n* Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +\u002F- whole pelvis\n* Patient must have a prostate specific antigen (PSA) \\>= 0.2 and \\\u003C 10 ng\u002FmL. If there is only one PSA value that has risen to \\>= 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be within \\>= 0.2 and \\\u003C 10 ng\u002FmL at least 2 weeks from the first value and within 28 days of enrollment\n* PSA doubling time must be calculated utilizing either all PSA measurements \\> 0.1 ng\u002FmL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements \\> 0.1 ng\u002FmL (if the latter, all 3 PSA measurements must be \\> 2 weeks apart to be used in the calculation). PSA doubling time must be \\> 3 months and \\\u003C 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used\n* Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging\n* Patient must have total testosterone level \\> 120 ng\u002FdL demonstrated within 42 days of enrollment\n* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Absolute neutrophil count (ANC) \\>= 1.0 X 10\\^9\u002FL\n* Platelet count \\>= 100 X 10\\^9\u002FL\n* Hemoglobin \\>= 9 g\u002FdL\n* Potassium \\>= 3.5\n* Serum bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) or =\\\u003C 3 X ULN for patients with documented Gilbert's syndrome\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 X ULN\n* Creatinine clearance (Cr Cl) \\>= 30 mL\u002Fmin as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement\n* Patient must be \\>= 18 years of age on day of signing informed consent\n* Patient must be able to understand and authorize informed consent\n\nExclusion Criteria:\n\n* Chronic active hepatitis B or C\n* History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin\n* Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET\u002FCT imaging or receive subsequent treatment\n* Any condition that would alter the patient's mental status, prohibiting understanding and\u002For authorization of informed consent\n* Expected lifespan of less than 12 weeks\n* Inability to lay still for imaging\n* Weight \\> 300 lbs. (due to equipment specifications)\n* Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and\u002For follow up",{"count":351,"type":22},100,[88],"This phase II trial studies how well prostate specific membrane antigen (PSMA) or fluciclovine positron emission tomography (PET)\u002Fcomputed tomography (CT) site-directed therapy works for treating patients with prostate cancer. PSMA or fluciclovine PET\u002FCT may detect prostate cancer early and may help to show whether patients benefit from site directed treatment to PET detected abnormalities.",[28],{"date":356,"type":40},"2026-07-07",{"date":358,"type":40},"2020-09-30",{"date":360,"type":22},"2037-07-01",{"name":362,"class":47},"University of Washington",2,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":48},"100578638","early-phase-1-an-investigational-scan-rhpsma-73-petct-for-detecting-biochemically-recurrent-prostate-cancer-enlighten-trial-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":372,"type":22},27,[374],"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.",[62,28],"2026-06-30",{"date":333,"type":40},{"date":380,"type":40},"2025-04-11",{"date":382,"type":22},"2032-02-01",{"name":384,"class":47},"Northwestern University",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":392,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":48},"100504723","early-phase-1-rhpsma-73-pet-mri-imaging-for-the-detection-of-prostate-cancer-among-men-who-are-otherwise-candidates-for-active-surveillance-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":394,"type":22},40,[374],"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.",[28,398,399,400],"Stage I Prostate Cancer AJCC v8","Stage IIA Prostate Cancer AJCC v8","Stage IIB Prostate Cancer AJCC v8",{"date":333,"type":40},{"date":403,"type":40},"2023-06-07",{"date":405,"type":22},"2035-06-07",{"name":384,"class":47},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":173,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":431,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":48},"100640530","phase-2-whole-versus-partial-gland-boost-during-prostate-sbrt-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)",{"count":415,"type":22},186,[88,59],"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.",[91,28],[420,421,422,423,424,425,426,427,428,429,430],"Prostate SBRT","Stereotactic Body Radiotherapy","Dose Escalation","Dominant Intraprostatic Lesion","DIL","Radiation Therapy","Genitourinary Toxicity","Gastrointestinal Toxicity","CTCAE","RTOG","EPIC","NOT_YET_RECRUITING","2026-06-25",{"date":434,"type":40},"2026-06-29",{"date":436,"type":22},"2026-07-25",{"date":438,"type":22},"2035-08-25",{"name":440,"class":47},"University of Nebraska",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":461},"100511958","phase-3-testing-shorter-duration-radiation-therapy-versus-the-usual-radiation-therapy-in-patients-with-high-risk-prostate-cancer-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":449,"type":22},1209,[59],"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.",[28,31,35],"2026-06-22",{"date":432,"type":40},{"date":456,"type":40},"2023-12-14",{"date":458,"type":22},"2036-03-31",{"name":460,"class":47},"NRG Oncology",413,{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100641117","phase-2-a-study-of-lower-dose-radiation-therapy-for-people-with-prostate-cancer-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":470,"type":22},54,[88],"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.",[91,28],[91,28,475,476,477],"DESTINATION 2","Memorial Sloan Kettering Cancer Center","26-150","2026-06-17",{"date":480,"type":40},"2026-06-18",{"date":482,"type":40},"2026-05-28",{"date":484,"type":22},"2030-05-28",{"name":476,"class":47},7,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":431,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":48},"100641941","phase-2-study-of-psma-targeted-therapy-and-androgen-receptor-suppression-in-low-volume-metastatic-prostate-cancer-sparkle-trial-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":496,"type":22},202,[88],"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.",[500,64,501,502,91,28,503,227,504,505,506,507],"Recurrent Prostate Adenocarcinoma","Castration-Sensitive Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Adenocarcinoma of the Prostate","Metastatic Prostate Cancer","Metastatic Prostate Adenocarcinoma","Advanced Prostate Cancer","Advanced Prostate Adenocarcinoma","2026-06-15",{"date":478,"type":40},{"date":511,"type":22},"2026-07-01",{"date":513,"type":22},"2030-12-30",{"name":515,"class":47},"Mayo Clinic",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":431,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":48},"100641448","effects-of-direct-artery-injection-on-prostate-cancer-drug-delivery-and-tumor-uptake-imaging-based-prediction-of-treatment-effectiveness-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":142,"type":22},[25],"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.",[91,28],[206,529,530,531],"Intraarterial PSMA injection","Texture analysis","Dose radicality prediction",{"date":480,"type":40},{"date":534,"type":22},"2026-08-01",{"date":536,"type":22},"2028-10-31",{"name":538,"class":47},"Lithuanian University of Health Sciences",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":546,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":561,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":48},"100590480","research-of-double-positive-circulating-cells-tumor-marker--cd45-in-several-types-of-metastatic-cancers-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":548,"type":22},450,[25],"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.",[552,553,28,554,555,556,557,558,559,560],"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",[562,563,564],"metastatic cancers","Double Positive Circulating cells","liquid biopsy","2026-06-12",{"date":508,"type":40},{"date":568,"type":40},"2025-07-23",{"date":570,"type":22},"2029-07-23",{"name":572,"class":47},"Institut Claudius Regaud",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":587,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":48},"100546235","phase-2-psma-directed-para-aortic-radiation-therapy-for-oligorecurrent-prostate-cancer-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":582,"type":22},34,[88],"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.",[91,28,586],"Hormone Sensitive Prostate Cancer",[588],"Oligorecurrent Disease",{"date":590,"type":40},"2026-06-16",{"date":592,"type":40},"2024-07-03",{"date":594,"type":22},"2029-08-01",{"name":596,"class":47},"University of Miami",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":608,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":616,"locationsCount":48},"100447651","the-use-of-ultrasound-in-assessing-post-prostatectomy-erectile-dysfunction-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",{"count":142,"type":22},[25],"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.",[28],[609],"Radical Prostatectomy","2026-06-05",{"date":612,"type":40},"2026-06-09",{"date":614,"type":40},"2023-10-02",{"date":536,"type":22},{"name":515,"class":47},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":23,"phases":626,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":48},"100490408","two-fraction-hdr-monotherapy-for-localized-prostate-cancer-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":625,"type":22},17,[25],"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.",[28,227],[630,204,631],"Brachytherapy","High Dose Rate","2026-06-04",{"date":610,"type":40},{"date":635,"type":40},"2024-09-11",{"date":637,"type":22},"2029-02-28",{"name":639,"class":47},"University of California, San Francisco",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":48},"100554498","phase-2-relugolix-and-enzalutamide-in-combination-with-radiation-therapy-for-the-treatment-of-very-high-risk-prostate-cancer-optimal-trial-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":648,"type":22},50,[88],"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.",[28],"2026-06-03",{"date":610,"type":40},{"date":655,"type":40},"2024-09-06",{"date":657,"type":22},"2032-11-19",{"name":659,"class":47},"Sean Sachdev"]