[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-prostate-cancer-ajcc-v8":501},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,41,68,120,148,170,190,212,233,253,272,292,316,333,353,375,397,418,437,459,480],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100511958",false,"NCT05946213","Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer","The Phase III 'High Five Trial' Five Fraction Radiation For High-Risk Prostate Cancer","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer\n* High-risk disease defined as having at least one or more of the following:\n\n  * cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \\[AJCC\\] 8th edition \\[Ed.\\]) Note: cT4 by imaging or on digital rectal exam is not allowed\n  * The patient's prostate specific antigen (PSA) value \\> 20 ng\u002FmL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors\n  * Gleason Score of 8-10\n  * Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm\n* Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan\n* No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* No prior radical prostatectomy\n* No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \\[HIFU\\], laser ablation, cryotherapy, irreversible electroporation \\[IRE\\], and vascular-targeted photodynamic therapy)\n* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \\[LHRH\\] agonist and oral anti-androgen) is =\\\u003C 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease\n* No contraindication to prostate MRI (required for planning of radiotherapy in both arms)\n* Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy","MALE","18 Years",{"count":18,"type":19},1209,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.",[25,26,27],"Prostate Adenocarcinoma","Stage III Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":32},"2023-12-14",{"date":36,"type":19},"2036-03-31",{"name":38,"class":39},"NRG Oncology","OTHER",413,{"id":42,"slug":4,"hasResults":10,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100435211","NCT04947254","Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer","Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer","Inclusion Criteria:\n\n* Completion of informed consent prior to any study specific procedures. Consent may be done remotely.\n* Patients must agree to tissue collection for correlative studies at the specified timepoints\n* Male aged 18 years and above\n* Histologically or cytologically confirmed prostate carcinoma\n* Localized or regional high-risk disease as defined by at least one of the following features: Prostate specific antigen (PSA) \\> 20 ng\u002FmL, T3a or higher, grade group 4-5 (i.e. Gleason score ≥ 8) as per National Comprehensive Cancer Network (NCCN) Prostate Cancer Version 2.2020 for high risk or very high risk prostate cancer, and\u002For regional lymph nodes positive for prostate cancer\n* Planned for definitive treatment of local regional prostate cancer using XRT and androgen ablation\n* Willing to undergo ongoing medical castration to maintain testosterone levels of ≤ 50 ng\u002FdL (≤ 2.0 nM) throughout systemic treatment or have undergone bilateral orchiectomy\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below:\n* Hemoglobin ≥ 10.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL\n* No features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) on peripheral blood smear\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease). (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x institutional upper limit of normal\n* Calculated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 mL\u002Fmin\n* Serum Albumin ≥ 3.0\n* Serum potassium ≥ 3.5 mmol\u002FL\n* Able to swallow study drugs whole as a tablet\u002Fcapsule\n* Patients who have partners of childbearing potential (e.g. female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use two methods of birth control including adequate barrier protection during the study and for 4 months after last dose of niraparib, abiraterone acetate, and\u002For apalutamide administration. In addition men should not donate sperm during this period. Please note that the efficacy of hormonal contraception may be decreased if administered with niraparib, abiraterone acetate, and\u002For apalutamide\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry\n\nExclusion Criteria:\n\n* Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor therapy\n* Patients who have prostate cancer with distant metastatic disease\n* Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer\n* Any unresolved toxicity (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade ≥ 2) from previous anti-cancer therapies\n* History or current diagnosis of MDS\u002FAML, and\u002For history of any malignancy \\[other than the one treated in this study\\] which has a ≥ 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or Ta urothelial carcinomas)\n* Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the principal investigator \\[PI\\]; the PI will serve as the final arbiter regarding eligibility)\n* Active or symptomatic viral hepatitis or chronic liver disease\n* Active pneumonitis or extensive bilateral lung disease of non-malignant etiology\n* Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples include, but are not limited to superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (HRCT) scan, uncontrolled seizures, history of allogeneic organ transplant, history of primary immunodeficiency or any psychiatric disorder that prohibits obtaining informed consent\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of study medication\n* Patients with a known hypersensitivity to niraparib, apalutamide, and\u002For abiraterone acetate\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \\[CNS\\] or meningeal disease which may require treatment with surgery or radiation therapy)\n* Severe or unstable angina, myocardial infarction (within 6 months prior to enrollment), symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), uncontrolled hypertension, or clinically significant ventricular arrhythmias within 6 months prior to randomization\n* Current evidence of any of the following:\n\n  * Gastrointestinal disorder affecting absorption\n  * Active uncontrolled infection (e.g., human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n  * Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone\u002Fprednisolone once daily\n  * Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency\n  * Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate\n  * Baseline moderate and severe hepatic impairment (Child-Pugh class B \\& C)\n  * Any condition that in the opinion of the investigator, would preclude participation in this study",{"count":48,"type":19},200,[50],"PHASE2","This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.",[53,54,26,55,56,57,27],"Prostate Carcinoma","Stage IIC Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","2026-06-19",{"date":60,"type":32},"2026-06-23",{"date":62,"type":32},"2021-08-05",{"date":64,"type":19},"2028-06-07",{"name":66,"class":39},"M.D. Anderson Cancer Center",1,{"id":69,"slug":4,"hasResults":10,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":10,"sex":74,"minAge":16,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100404756","NCT04550494","Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations","A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response","Inclusion Criteria:\n\n* Adult patients with solid tumors and documented germline or somatic aberrations in genes involved in DNA damage response (DDR) and whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options. Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable for determination of eligibility\n* Patients with the following germline or somatic genetic aberrations will be eligible based on compelling preclinical and\u002For clinical data suggesting that these deleterious mutations confer sensitivity to PARP inhibitors; no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene will be enrolled\n\n  * Deleterious BRCA1 or BRCA2 mutations\n  * Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN\n  * A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L\n* Age \\>= 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Life expectancy of greater than 3 months\n* Leukocytes \\>= 3,000\u002FmcL\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 10 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (=\\\u003C 3 x upper limit of normal in the presence of documented Gilbert's syndrome or liver metastases at baseline)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal\n* Creatinine =\\\u003C 1.5 x institutional upper limit of normal OR Creatinine clearance (CrCl) \\>= 60 mL\u002Fmin\u002F1.73m\\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73m\\^2\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 20 mm (\\>= 2 cm) by chest x-ray or as \\>= 10 mm (\\>= 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Patients must have a tumor site amenable to biopsy. If avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST measurements\n* The effects of talazoparib on the developing human fetus are unknown. For this reason and because PARP inhibitors are known to be teratogenic, women of child-bearing potential must agree to use a highly effective method of contraception for the duration of study participation and for at least 7 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male patients with female partners of reproductive potential and pregnant partners who are treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for at least 4 months after completion of talazoparib administration\n* Patients must be able to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube) administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients must have recurrent, locally advanced or metastatic disease\n* Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention, except for those patients without SOC or for whom talazoparib is SOC\n* PATIENTS WITH OVARIAN CANCER:\n* All patients with ovarian cancer should have one prior platinum-based therapy\n* Patients with ovarian cancer with platinum-sensitive disease are eligible. Patients with platinum-refractory disease are not eligible\n* Patients with gBRCAm ovarian cancer must also have progressed on a PARP inhibitor. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH PANCREATIC CANCER:\n* All patients with pancreatic cancer should have received prior platinum-containing therapy in the metastatic setting\n* PATIENTS WITH BREAST CANCER:\n* Patients with HER2+ breast cancer should have had 2 prior systemic lines of therapy in the metastatic setting, including anti-HER2 therapy\n* Patients with breast cancer who are eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals must have had prior PARP inhibitor as per FDA indication. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH GASTRIC CANCER:\n* Patients with HER2+ gastric cancer should have had received anti-HER2 therapy in the metastatic setting\n* PATIENTS WITH PROSTATE CANCER:\n* Patients with prostate cancer who are eligible for a PARP inhibitor by FDA approvals must have had prior PARP inhibitor for eligibility. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* All patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on prior therapy\n* Patients with castration resistant prostate cancer must have castrate levels of testosterone (\\\u003C 50 ng\u002FdL \\[1.74 nmol\u002FL\\])\n* Patients with metastatic hormone receptor (HR) prostate cancer and mutations in either BRCA1, BRCA2, or ATM should continue to receive anti-androgen receptor (anti-AR) therapy\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter (6 weeks for nitrosoureas or mitomycin C). Patients must be \\>= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be \\>= 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events\n* Patients who have had prior treatment with talazoparib are ineligible\n* Patients who have had prior monoclonal antibody therapy must have completed that therapy \\>= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment) except for monoclonal antibody therapies that have been proven to be safe when combined with PARP inhibitor (PARPi) treatment (such as anti-PD-1\u002FPD-L1 and anti-HER2), which must be completed \\>= 4 weeks prior to enrollment\n* Patients who are receiving any other investigational agents\n* Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for \\>= 1 month without requiring steroid and anti-seizure medication are eligible to participate\n* Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib will be determined following review by the principal investigator\n* 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\n* Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown\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 who require use of coumarin-derivative anticoagulants such as warfarin are excluded. Low-dose warfarin (=\\\u003C 1 mg\u002Fday) is permitted\n* Women who are currently lactating\n* History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled","ALL",{"count":76,"type":19},36,[50],"This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors \"one after the other\" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.",[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,26,107,108,109],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Castration-Resistant Prostate Carcinoma","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","HER2-Positive Breast Carcinoma","Locally Advanced Breast Carcinoma","Locally Advanced Gastric Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Ovarian Carcinoma","Locally Advanced Pancreatic Carcinoma","Locally Advanced Prostate Carcinoma","Metastatic Breast Carcinoma","Metastatic Gastric Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Pancreatic Carcinoma","Metastatic Prostate Carcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Breast Carcinoma","Recurrent Gastric Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Pancreatic Carcinoma","Recurrent Prostate Carcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","2026-06-18",{"date":29,"type":32},{"date":113,"type":32},"2021-04-26",{"date":115,"type":19},"2026-12-01",{"name":117,"class":118},"National Cancer Institute (NCI)","NIH",4,{"id":121,"slug":4,"hasResults":10,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":10,"sex":15,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":20,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100554521","NCT06500169","Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors","Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)","GREENS","Inclusion Criteria:\n\n* First time, primary diagnosis of prostate cancer (PCa)\n* Currently receiving androgen deprivation therapy (ADT) and\u002For androgen receptor blocker) for more than 6 months\n* Older adult male: 55-85 years old\n* The ability to stand independently without external support\n* No or minimal golf experience (played \\\u003C 5 times in the past 10 years)\n* English speaking\n\nExclusion Criteria:\n\n* Second cancer diagnosis (excluding non-invasive skin cancers) or bone metastases\n* Prostatectomy less than 6 months prior to study enrollment (prostatectomy is not a requirement for study entry)\n* Symptomatic cardiovascular disease, active angina, uncontrolled hypertension (systolic blood pressure (SBP) \\> 160 or diastolic blood pressure (DBP) \\> 90, high resting pulse heart rate (HR) \\> 90), symptomatic orthostatic hypotension\n* Unstable asthma, exacerbated chronic obstructive pulmonary disease (COPD\\]\n* History of injury or orthopedic operation within the last 6 months\n* Movement disorders (e.g., Parkinson's disease (PD) or other neurological disorders), hemiparesis or paraparesis\n* Severe vision or hearing problems","55 Years","85 Years",{"count":130,"type":19},20,[132],"NA","This clinical trial evaluates a golf recreational exercise program for enhancing survivorship in underrepresented prostate cancer survivors. Golf is a multimodal recreational activity that requires participants to utilize all muscle groups to perform the golf swing, walk over hilly and uneven terrain, maintain balance during putting and squat-like tasks. Physical activity and exercise are beneficial to physical function, cognitive function, psychosocial health, and overall quality of life during prostate cancer survivorship. These aspects of health are impacted by prostate cancer treatment, especially androgen deprivation therapy. Additionally, supervised, group-based activity programs facilitate participation in physical activity. Researchers want to examine the changes in functional abilities, psychosocial health, and quality of life following participation in in a golf program designed for prostate cancer survivors.",[135,91,136,137,26],"Localized Prostate Carcinoma","Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage II Prostate Cancer AJCC v8","2026-05-29",{"date":140,"type":32},"2026-06-03",{"date":142,"type":32},"2023-09-01",{"date":144,"type":19},"2027-12-31",{"name":146,"class":39},"University of Southern California",2,{"id":149,"slug":4,"hasResults":10,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":20,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":67},"100572444","NCT06733350","Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance","Investigating the Effect of Testosterone Replacement Therapy Among Hypogonadal Men With Localized Prostate Cancer on Active Surveillance","Inclusion Criteria:\n\n* Men aged ≥ 18 years\n* Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network \\[NCCN\\] very low, low, and intermediate favorable risk group)\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer\n* For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,\n\n  * Locally advanced or metastatic prostate cancer\n  * Male breast cancer\n  * Men with an active desire to have children\n  * Hematocrit levels \\> 54% or baseline hematocrit of 48-50%\n  * Uncontrolled or poorly controlled congestive heart failure\n  * IPSS (International Prostate Symptom Score) score \\> 19\n  * Family history of venous thromboembolism\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study",{"count":155,"type":19},600,[157],"PHASE4","This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.",[135,160,137,26],"Stage I Prostate Cancer AJCC v8","2026-05-13",{"date":163,"type":32},"2026-05-14",{"date":165,"type":32},"2025-01-15",{"date":167,"type":19},"2029-01-15",{"name":169,"class":39},"Roswell Park Cancer Institute",{"id":171,"slug":4,"hasResults":10,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":20,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":67},"100476738","NCT05487846","Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation","ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation","Inclusion Criteria:\n\n* Provide signed and dated informed consent form\n* English speaking only\n* Willing to comply with all study procedures and be available for the duration of the study\n* Any individual \\>= 18 years old\n* African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age \\\u003C 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline\n\nExclusion Criteria:\n\n* Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded\n* Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded",{"count":177,"type":19},120,[132],"This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.",[97,26,109],"2026-04-09",{"date":183,"type":32},"2026-04-14",{"date":185,"type":32},"2025-01-01",{"date":187,"type":19},"2026-09",{"name":189,"class":39},"Thomas Jefferson University",{"id":191,"slug":4,"hasResults":10,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":10,"sex":15,"minAge":196,"maxAge":128,"enrollmentInfo":197,"targetDuration":4,"studyType":20,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":67},"100546042","NCT06389786","Accuracy of 18F-rhPSMA-7.3 PET\u002F MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer","MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET\u002FCT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis","Inclusion Criteria:\n\n* Male subjects ≥ 30 and ≤ 85 years old\n* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)\n* Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling\n* Planned elective radical prostatectomy with extended pelvic lymph node dissection\n* Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery\n* Patient agrees to comply with the investigator instructions\n* Patient agrees to comply with the follow-up surveillance schedule\n* Have ability to provide full written consent\n\nExclusion Criteria:\n\n* High-risk cancer planned for neoadjuvant therapy\n* Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study\n* Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration\n* Clinical oligometastatic disease with \\> 3 nodes positive preoperative standard of care imaging of prostate region\n* Previous history of pelvic radiation\n* Patients with obesity defined as body mass index (BMI) \\> 40 kg\u002Fm\\^2\n* History of prior laparoscopic inguinal hernia repair with mesh\n* Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period\n* Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging\n* Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments\n* Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment\n* Received administration of an investigational drug within 30 days prior to study registration, and\u002For has planned administration of another investigational product or procedure during participation in this study","30 Years",{"count":198,"type":19},50,[132],"This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \\[PET\\]\u002Fmagnetic resonance imaging \\[MRI\\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET\u002Fcomputed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET\u002FCT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET\u002F MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.",[135,202,160,137,26,27],"Oligometastatic Prostate Carcinoma","2026-04-01",{"date":205,"type":32},"2026-04-06",{"date":207,"type":32},"2024-06-11",{"date":209,"type":19},"2027-05-31",{"name":211,"class":39},"Mayo Clinic",{"id":213,"slug":4,"hasResults":10,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":20,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100541068","NCT06325046","Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer","ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions","Inclusion Criteria:\n\n* Gender assigned male at birth: age ≥ 18 years\n* Histological confirmation of prostate adenocarcinoma\n* National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Signed informed consent\n* Willing to complete requirements for follow-up (during active monitoring phase)\n\nExclusion Criteria:\n\n* NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma\n* Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)\n* Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.\n* Metastatic disease by conventional or molecular imaging\n* Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation\n* Concurrent antineoplastic agents (chemotherapy)\n* Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years\n* Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up\n* Prostate gland volume \\> 80 cc based on magnetic resonance imaging (MRI), and\u002For International Prostate Symptom Score (IPSS) composite score \\> 17\n* Body weight \\> 200 kilogram\n* Known allergy or sensitivity to polyethylene glycol (PEG) or iodine",{"count":219,"type":19},144,[132],"This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.",[223,160,137,26],"Localized Prostate Adenocarcinoma","2026-03-26",{"date":226,"type":32},"2026-03-31",{"date":228,"type":32},"2024-08-15",{"date":230,"type":19},"2031-08-30",{"name":211,"class":39},5,{"id":234,"slug":4,"hasResults":10,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":20,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":67},"100598615","NCT07073794","Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer","A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse \\[co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted\\]\n\n  * Androgen deprivation therapy (ADT):\n\n    * Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length\n    * Degarelix SQ, 4 weeks cycle length\n  * Chemotherapy: Cabazitaxel IV, 3 weeks cycle length\n  * Immunotherapy: Pembrolizumab IV, 3 weeks cycle length\n  * Bone modifying agent + any of the prostate cancer treatments:\n\n    * Zoledronic acid IV, 4 or 12 weeks cycle length\n    * Denosumab SQ, 4 or 12 weeks cycle length\n* Patients who are anticipated to continue the treatment regimen they are currently prescribed for at least 18 weeks following registration (if on chemotherapy or immunotherapy) or 24 weeks following registration (for all other treatment regimens)\n* Residing within the area serviced by supplier\n* Provide written informed consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 for patients on any qualifying treatment (tx) regimen; ECOG PS 0, 1, 2, or 3 for patients on ADT with or without second generation antiandrogen\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to follow birth control requirements for males of reproductive potential\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)\n* Anticipation of the need for major surgery during the course of study treatment\n\n  * Note: Concomitant radiation therapy during the study period is allowed\n* Not cleared for treatment in home via social stability screening\n* Patients who received at home treatment through involvement in another CCBW trial\n\n  * Note: Patients who enrolled in another CCBW trial but had to be withdrawn prior to initiating treatment in the home would still be eligible",{"count":240,"type":19},38,[50],"This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.",[244,91,97,26,109],"Biochemically Recurrent Prostate Carcinoma","2026-03-23",{"date":247,"type":32},"2026-03-25",{"date":249,"type":32},"2025-08-27",{"date":251,"type":19},"2028-08-27",{"name":211,"class":39},{"id":254,"slug":4,"hasResults":10,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":20,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":67},"100594893","NCT07025369","Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET\u002FCT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial","Phase 2 Randomized Study to Assess Use of Androgen Deprivation to Enrich PSMA Expression and Improve Sensitivity of Staging PSMA PET\u002FCT: The EnrichPSMA Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histological confirmation of prostate adenocarcinoma\n* Diagnosis of high risk or very high risk prostate cancer per National Comprehensive Cancer Network (NCCN) Risk Stratification. \\[Any of the following: grade group 4 or 5, prostate-specific antigen (PSA) greater than 20, radiographic cT3 on MRI\\]\n* Testosterone greater than or equal to 300\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 120 days prior to registration\u002Frandomization)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 120 days prior to registration\u002Frandomization)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 120 days prior to registration\u002Frandomization)\n* Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of ORGOVYX (relugolix) for the time period specified:\n\n  * Use a condom during sex while being treated and for 30 days after the last dose of ORGOVYX (relugolix)\n  * Do not make semen donations during treatment and for 30 days after the last dose of ORGOVYX (relugolix)\n  * Those with female partners of childbearing potential may be enrolled if they are:\n\n    * Documented to be surgically sterile (i.e., vasectomy);\n    * Committed to practicing true abstinence during treatment and for 30 days after the last ORGOVYX (relugolix) dose; or\n    * Committed to using an effective method of contraception with their partner during treatment and for 30 days following the last dose of ORGOVYX (relugolix)\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Any of the following prior therapies:\n\n  * Chemotherapy ≤ 2 weeks prior to registration\u002Frandomization\n  * Androgen deprivation therapy\n  * Pelvic radiation\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy ≤ 1 year prior to registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other active treatment for their cancer\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Use of P-glycoprotein inhibitors",{"count":260,"type":19},30,[50],"This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)\u002Fcomputed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET\u002FCT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET\u002FCT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET\u002FCT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET\u002FCT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.",[25,54,26,109],"2026-03-12",{"date":266,"type":32},"2026-03-13",{"date":268,"type":32},"2025-08-25",{"date":270,"type":19},"2026-12-31",{"name":211,"class":39},{"id":273,"slug":4,"hasResults":10,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":20,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":67},"100529406","NCT06173362","Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer","A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide","Inclusion Criteria:\n\n* Ability to understand and willingness to sign an informed consent form\n* Histologically confirmed prostate adenocarcinoma\n* Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician\n* Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy\n* Performance status 0 - 2 (Karnofsky ≥ 50%)\n* Age ≥ 18 years at time of consent\n* Life expectancy ≥ 6 months per investigator discretion\n* Ability and stated willingness to adhere to the study visit schedule and other protocol procedures\u002Frequirements for the duration of the study\n\nExclusion Criteria:\n\n* Have been on either abiraterone or darolutamide for \\> 28 days prior to initiating enrollment\n* Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial",{"count":279,"type":19},75,[50],"This phase II trial compares the effects, good and\u002For bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.",[283,26,109],"Advanced Prostate Adenocarcinoma","2026-03-11",{"date":266,"type":32},{"date":287,"type":32},"2023-11-09",{"date":289,"type":19},"2027-05",{"name":291,"class":39},"University of California, Davis",{"id":293,"slug":4,"hasResults":10,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":20,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":119},"100566084","NCT06650579","REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial","Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial","Inclusion Criteria:\n\n* Men ≥ 18 years old\n* Non-metastatic prostate cancer\n* Non-metastatic, biochemically recurrent prostate cancer\n* Plan to undergo curative-intent pelvic radiation therapy (photons or protons) with or without brachytherapy\n* Plan to undergo up to 24 months of combination androgen deprivation therapy (ADT) plus AA and prednisone\n\nExclusion Criteria:\n\n* Metastatic prostate cancer requiring indefinitive ADT or chemotherapy\n* Prior exposure to androgen deprivation therapy\n* Prior exposure to chemotherapy, immunotherapy, or radiation therapy\n* History of cardiac bypass surgery or percutaneous coronary intervention\n* History of cardiac pacemaker or defibrillator",{"count":299,"type":19},72,[22],"This phase III\u002FIV trial compares the impact of leuprolide and abiraterone acetate (AA) versus relugolix and AA on the heart in hormone-naive patients with advanced prostate cancer receiving pelvic radiation therapy. Leuprolide is in a class of medications called gonadotropin-releasing hormone agonists (GNRHa). It prevents the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate tumor cells that need testosterone to grow. Abiraterone acetate, an androgen biosynthesis inhibitor, works by decreasing the amount of certain hormones in the body. Relugolix, a GNRH antagonist, works by decreasing the amount of testosterone produced by the body. This may slow or stop the spread of prostate tumor cells that need testosterone to grow. The use of hormone therapy with radiation therapy has been shown to improve survival, however, studies have suggested that the addition of hormone therapy may worsen heart (cardiac) disease and high blood pressure. In fact, studies have shown that the most common cause of death in prostate cancer patients is due to heart disease or heart attacks. Computed tomography (CT) scans create a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. In this study, sophisticated cardiac CT images are used to take pictures of patients' heart and coronary arteries to help assess damage to the heart. Using cardiac CT and blood tests, this trial may help doctors determine which patients are at risk of cardiac disease when treated with combination hormone therapy, as well as the differential risk of leuprolide versus relugolix in combination with abiraterone acetate.",[103,26,27],[304,305,306],"node-positive prostate cancer","advanced prostate cancer","very-high-risk prostate cancer","2026-02-22",{"date":309,"type":32},"2026-02-24",{"date":311,"type":32},"2025-01-31",{"date":313,"type":19},"2029-07-01",{"name":315,"class":39},"Emory University",{"id":317,"slug":4,"hasResults":10,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":20,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":332,"locationsCount":67},"100418222","NCT04725903","Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer","Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer","Inclusion Criteria:\n\n* Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:\n\n  * Gleason grade 8 or higher\n  * cT3b (seminal vesicle involvement) or cT4\n  * Prostate specific antigen \\[PSA\\] \\> 20 (or PSA \\>10 if on finasteride)\n  * Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins\n* Zubrod performance status 0-2\n* Complete blood cell (CBC)\u002Fdifferential obtained within 90 days prior to registration on study\n* Absolute neutrophil count (ANC) \\>= 1,500 cells\u002Fmm\\^3\n* Platelets \\>= 100,000 cells\u002Fmm\\^3\n* Hemoglobin \\>= 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 8.0 g\u002Fdl is acceptable)\n* Patient must be able to provide study specific informed consent\n\nExclusion Criteria:\n\n* Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.\n* Absence of distant lymph node metastasis by CT and\u002For MRI before the start of therapy.\n* Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer\n* Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields\n* Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel disease, human immunodeficiency virus infection, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":260,"type":19},[132],"This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.",[26,55,56,57],"2026-02-12",{"date":328,"type":32},"2026-02-17",{"date":330,"type":32},"2021-02-01",{"date":144,"type":19},{"name":315,"class":39},{"id":334,"slug":4,"hasResults":10,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":20,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":67},"100614195","NCT07276438","Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Cancer, MANTICORE Trial","MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)","Inclusion Criteria:\n\n* Age ≥ 18\n* Histologically confirmed, clinically localized adenocarcinoma of the prostate\n* Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping\n\n  * Advanced imaging studies (i.e. prostate-specific membrane antigen \\[PSMA\\] positron emission tomography \\[PET\\]\u002FCT and fluciclovine PET\u002FCT scan) can supplant a bone scan if performed first\n* No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET\u002FCT scan below the bifurcation of the renal arteries are amenable)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* No indication for urgent or emergent radiation\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator\n* Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate\n* Prior pelvic radiotherapy\n* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data",{"count":340,"type":19},186,[132],"This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist \"re-optimize\" the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size\u002Fshape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.",[223,160,137,26],"2026-02-03",{"date":346,"type":32},"2026-02-05",{"date":348,"type":32},"2025-12-01",{"date":350,"type":19},"2032-12-31",{"name":352,"class":39},"Jonsson Comprehensive Cancer Center",{"id":354,"slug":4,"hasResults":10,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":20,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":374},"100531862","NCT06205316","SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma","Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma at the time of surgery\n* Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \\[AJCC\\] Criteria 8th edition \\[Ed.\\])\n* PSA post radical prostatectomy ≥ 0.1 and \\\u003C 2.0 ng\u002FmL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment\n* Patients must sign institutional review board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests within the specified time frames\n* Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration\n* Patients must be ≥ 18 years old\n* Prostate cancer up to oligometastatic disease, up to 5 sites\n\nExclusion Criteria:\n\n* Previous pelvic radiation\n* Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng\u002FmL\n* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)\n* Prior systemic chemotherapy for prostate cancer\n* History of proximal urethral stricture requiring dilatation\n* Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and\u002For interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)\n* History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months\n* On a transplant list\n* More than oligometastatic disease \\> 5 metastatic sites",{"count":360,"type":19},118,[22],"This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.",[244,202,364,365,54,26,109],"Recurrent Prostate Adenocarcinoma","Stage IIB Prostate Cancer AJCC v8","2026-01-16",{"date":368,"type":32},"2026-01-20",{"date":370,"type":32},"2024-01-22",{"date":372,"type":19},"2030-01-22",{"name":211,"class":39},6,{"id":376,"slug":4,"hasResults":10,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":10,"sex":15,"minAge":382,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":20,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100503704","NCT05838716","Vitamin D for Prostate Endocrine Therapy","High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients","ViPER","Inclusion Criteria:\n\n* Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)\n* Be age 50 years or older\n* Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \\[LHRH\\] antagonists and LHRH agonists are permitted)\n* Have a total serum vitamin D between 10 and 32 ng\u002Fml\n* Have a total serum calcium of less than or equal to 10.5 mg\u002Fdl\n* Have a normal GFR (glomerular filtration rate \\> 30ml)\n* Agree not to take calcium and\u002For vitamin D supplements for the duration of the intervention other than those provided by the study\n* Be able to provide written informed consent\n* Be able to swallow pills and capsules\n* Be able to speak and read English\n\nExclusion Criteria:\n\n* Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment\n* Have a diagnosis of stage IV chronic kidney disease\n* Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg\u002Fdl)\n* Have a history of hypercalcemia or vitamin D toxicity\u002Fsensitivity","50 Years",{"count":384,"type":19},240,[22],"This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.",[160,137,26,27],"2026-01-14",{"date":390,"type":32},"2026-01-15",{"date":34,"type":32},{"date":393,"type":19},"2029-04-29",{"name":395,"class":39},"University of Rochester",51,{"id":398,"slug":4,"hasResults":10,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":10,"sex":15,"minAge":404,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":20,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":67},"100588351","NCT06940271","Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy","RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy","RAP","Inclusion Criteria:\n\n* Male subjects with age ≥ 45\n* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)\n* Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer\n* Planned elective radical prostatectomy with bilateral nerve sparing technique\n* Negative urinalysis within 30 days prior to date of surgery\n* Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation\n* Willing to comply with instruction of the investigator\n* Willing to comply with follow-up surveys\n* Ability to provide written consent\n* Negative urinary tract infection at the time of consultation\n* Interest in penetrative sexual intercourse\n\nExclusion Criteria:\n\n* High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles\n* Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and\u002For injectable medications\n* History of \\>14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period\n* Prior hormonal therapy such as Lupron or oral anti-androgens\n* Poor urinary control at baseline requiring the use of pads for leakage\n* Previous history of pelvic radiation\n* Previous history of simple prostatectomy or transurethral prostate surgery\n* Patients with obesity defined as body mass index (BMI) \\> 40 kg\u002Fm\\^2\n* History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair)\n* Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period\n* Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments\n* Has any condition(s) which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment\n* In the opinion of the principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration\n* Allergic to aminoglycoside antibiotics (such as gentamicin and\u002For streptomycin)\n* Received administration of an investigational drug within 30 days prior to registration, and\u002For has planned administration of another investigational product or procedure during participation in this study","45 Years",{"count":406,"type":19},25,[132],"This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.",[135,160,137,26],"2025-11-07",{"date":412,"type":32},"2025-11-10",{"date":414,"type":32},"2025-08-14",{"date":416,"type":19},"2030-07-30",{"name":211,"class":39},{"id":419,"slug":4,"hasResults":10,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":20,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":67},"100592563","NCT06995053","Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of Localized Prostate Cancer, ILLUSION Trial","Image-Guidance With Triggered Beam Hold To Implanted Fiducial Markers or Hypersight for Stereotactic Body Radiotherapy for Prostate Cancer (ILLUSION)","ILLUSION","Inclusion Criteria:\n\n* Histologically confirmed, clinically localized adenocarcinoma of the prostate\n* No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a prostate-specific membrane antigen \\[PSMA\\] positron emission tomography \\[PET\\]\u002FCT scan below the bifurcation of the renal arteries are amenable)\n* Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping\n* Advanced imaging studies (i.e. PSMA PET\u002FCT and fluciclovine PET\u002FCT scan) can supplant a bone scan if performed first\n* Age ≥ 18\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator\n* Prior whole gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate\n* Prior pelvic radiotherapy\n* History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia\n* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data",{"count":426,"type":19},80,[132],"This clinical trial studies the side effects of computed tomography (CT)-guided stereotactic body radiation therapy (SBRT) with intrafraction motion monitoring and to see how well it works in treating patients with prostate cancer that has not spread to other parts of the body (localized). In CT-guided SBRT, x-ray-based imaging and cone-beam CTs are used to define and localize the area to be treated with SBRT. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. A recent randomized trial showed that while SBRT is associated with less urinary incontinence and erectile dysfunction than complete surgical removal of the prostate, there are more urinary irritative side effects and more bowel side effects than with surgery. One source of uncertainty in SBRT that may contribute to genitourinary (GU) and gastrointestinal (GI) side effects is the necessity of treating a \"margin\" of volume around the prostate to account for its movement during SBRT. Intrafraction motion monitoring is any technique or system designed to track the movement of the body and target during fractions of external beam radiation to keep the beam on target. This allows for the patient to be repositioned, if needed, to ensure delivery of the SBRT to only the planned treatment area. CT-guided SBRT with intrafraction motion monitoring may lower GU and GI side effects by allowing tighter margins, as has been demonstrated with magnetic resonance imaging (MRI)-guided SBRT.",[223,160,137,26],"2025-11-06",{"date":412,"type":32},{"date":433,"type":32},"2025-06-27",{"date":435,"type":19},"2036-09-01",{"name":352,"class":39},{"id":438,"slug":4,"hasResults":10,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":10,"sex":15,"minAge":443,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":20,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":67},"100506076","NCT05869682","Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy","Phase 2 Study of Bright White Light During Treatment With ADT Combination Therapy in Men With Advanced Prostate Cancer to PreServe PHysIcal and MeNtal HEalth (SHINE)","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed prostate cancer\n* Participants must have radiographic evidence of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 10 mm ( \\>= 1 cm) with computed tomography (CT) scan or magnetic resonance imaging (MRI), or metastatic lesions as identified as related to prostate cancer on a standard technetium bone scan. Alternatively patients may have radiographic evidence of metastatic disease on an Axumin or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) scan\n* Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer) plus abiraterone acetate and prednisone or darolutamide (triplet therapy), or ADT plus enzalutamide, apalutamide, or darolutamide (doublet therapy). Prior use of ADT with a gonadotropin hormone-releasing hormone (GnRH) agonist or antagonist, or prior orchiectomy is allowed\n* Age \\>= 60 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Expected time to next treatment of \\>= 12 months and life expectancy of \\>= 18 months, as determined by a study Investigator\n* Leukocytes \\>= 3,000\u002FmcL\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Total bilirubin =\\\u003C institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Creatinine =\\\u003C institutional ULN OR\n* Glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants 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* Participants 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, participants should be class 2B or better\n* Ability to understand and the willingness to sign a written informed consent document\n* Participants are still eligible and may proceed with the protocol and bright white light therapy if they discontinue baseline hormonal treatment, but plan to continue with another of the eligible treatments. However, if they discontinue treatment due to cancer progression, they should not continue on the protocol\n\nExclusion Criteria:\n\n* Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer as the expected median time to progression to next therapy is \\\u003C 12 months\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide for participants planning to start treatment with abiraterone acetate, enzalutamide, apalutamide, or darolutamide\n* Participants who are receiving any other investigational agents\n* Participants with brain metastases are ineligible due to the limited life expectancy of men with prostate cancer metastases to brain\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study\n* Histologic evidence of small cell prostate cancer\n* Symptomatic skeletal event complication of prostate cancer such as cord compression, fracture, or need for radiation or surgery to a bone lesion within 6 months\n* Uncontrolled pain related to prostate cancer or separate chronic condition\n* Visceral crisis from prostate cancer suggesting rapidly progressive disease and life expectancy of \\\u003C 18 months\n* Participants with uncontrolled intercurrent illness\n* Concurrent second active malignancy\n* Severe sleep disorders (e.g. Narcolepsy)\n* Eye Diseases which limit the ability of light to be processed (e.g. untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or other retinal disorder)\n* Severe psychological impairment (e.g., bipolar disorder or manic episodes)\n* Current employment in night shift work\n* Previous use of light therapy to alleviate fatigue or depressive symptoms\n* Currently recovering from previous eye surgery within the past 6 months that causes eye irritation\n* Sensitivity to light, epilepsy, or a history of seizures","60 Years",{"count":445,"type":19},210,[50],"This phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment with antiandrogen therapy (ADT) combination therapy. Combination treatment including ADT plus chemotherapy and androgen receptor (AR) targeted therapy or ADT plus AR targeted therapies work by reducing testosterone. Most prostate tumor cells rely on testosterone to help them grow; therefore, ADT combination therapy causes prostate tumor cells to die or to grow more slowly leading to improved overall survival in men with advanced prostate cancer when compared with ADT alone. However, lower levels of testosterone is also commonly associated with worsening fatigue and depression. If prolonged and severe, these complications can alter patient treatment plans, impacting not just quality of life, but leading to inadequate cancer control. BWL therapy is a type of phototherapy that utilizes bright white full-spectrum light, either through a light box or light therapy glasses to help regulate circadian rhythms. Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle, including the sleep-wake cycle which can become disrupted in cancer patients undergoing treatment, leading to increased fatigue. Additionally, exposure to bright light may increase the production of serotonin, a neurotransmitter that is associated with mood regulation. BWL therapy with AYOpro light therapy glasses may serve as a supportive care measure for men with advanced prostate to help reduce fatigue, as well as improve mood and overall quality of life during ADT combination therapy to maintain cancer care without suffering complications of therapy.",[449,97,53,26,109],"Advanced Prostate Carcinoma","2025-10-02",{"date":452,"type":32},"2025-10-06",{"date":454,"type":32},"2024-07-09",{"date":456,"type":19},"2028-11-30",{"name":458,"class":39},"City of Hope Medical Center",{"id":460,"slug":4,"hasResults":10,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":20,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":67},"100435087","NCT04945642","High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma","Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)","HYDRA","Inclusion Criteria:\n\n* Ability to understand a written informed consent document, and the willingness to sign it\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* History\u002Fphysical examination with digital rectal examination of the prostate within 8 weeks prior to registration\n* Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \\> 10, and\u002For Gleason score \\>= 7\n* No evidence of disease beyond the prostate and\u002For seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)\n* Prostate size =\\\u003C 60cc\n* International Prognostic Scoring System (IPSS) score =\\\u003C 15\n* Able to safely receive moderate sedation or general anesthesia\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous\u002Fhematogenous malignancy unless continually disease free for a minimum of 5 years\n* Regional lymph node involvement\n* Evidence of distant metastases\n* Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer\n* Previous pelvic irradiation or prostate brachytherapy\n* Previous or concurrent cytotoxic chemotherapy for prostate cancer\n* Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery\n* Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment",{"count":467,"type":19},52,[132],"This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.",[25,471,54,26,55,56,57,27],"Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","2025-07-11",{"date":474,"type":32},"2025-07-15",{"date":476,"type":32},"2021-08-20",{"date":478,"type":19},"2027-07-01",{"name":352,"class":39},{"id":481,"slug":4,"hasResults":10,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":20,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":491,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":67},"100526062","NCT06129851","Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer","Quantifying Optimal Relugolix Duration With Radiation in High Risk Prostate Cancer (QURE-PC)","Inclusion Criteria:\n\n* Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1\n* Life expectancy \\> 5 years\n* Patient diagnosed with National Comprehensive Cancer Network (NCCN) high risk and very high risk prostate cancer.\n\n  * High risk is defined as:\n\n    * T3a or\n    * Grade group 4 or 5 or\n    * Prostate-specific antigen (PSA) \\> 20 ng\u002FmL\n  * Very high risk is defined as:\n\n    * T3b to T4 or\n    * Primary Gleason pattern 5 or\n    * Two or three high-risk features or\n    * \\> 4 cores with grade group 4 or 5\n* Eligible for treatment with combination brachytherapy, external beam radiation, and ADT\n* Leukocytes \\>= 1.0 K\u002FUL\n* Platelets \\>= 100 K\u002FUL\n* Hemoglobin ≥ 9 g\u002FdL\n* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN)\n* Men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed for the duration of study participation and for 2 weeks following completion of relugolix therapy\n\nExclusion Criteria:\n\n* Simultaneously enrolled in any therapeutic clinical trial\n* Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study\n* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n* Has a known allergic reaction to any excipient or component contained in the study drug formulation\n* Active grade 3 (per the National Cancer Institute \\[NCI\\] CTCAE, version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment\n* Current androgen deprivation therapy (unless testosterone \\> 50 ng\u002FdL). Please note prior or concurrent bicalutamide at 50 mg\u002Fdaily or less is allowed. Prior androgen deprivation therapy is allowed if testosterone has recovered to \\> 50 ng\u002FdL\n* Prolonged echocardiogram corrected QT (QTc) interval \\> 440 ns\n* Prior pelvic therapy that would significantly overlap with radiation treatment fields\n* Prior prostatectomy",{"count":487,"type":19},90,[50],"This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). ADT is used to lower the amount of testosterone in the body, because testosterone appears to help prostate cancer grow. Relugolix works to reduce testosterone levels, which may inhibit proliferation of prostate cancer cells. It is approved by the Food and Drug Administration to treat prostate cancer. Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy, but the optimal duration of relugolix in combination with radiation is not known.",[54,26,109],"NOT_YET_RECRUITING","2023-11-03",{"date":494,"type":32},"2023-11-13",{"date":496,"type":19},"2023-11-20",{"date":498,"type":19},"2026-10-23",{"name":500,"class":39},"University of Kansas Medical Center",""]