[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iic-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iic-prostate-cancer-ajcc-v8":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,69,91,115,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100435211","phase-2-androgen-ablation-therapy-with-or-without-niraparib-after-radiation-therapy-for-the-treatment-of-high-risk-localized-or-locally-advanced-prostate-cancer-100435211",false,"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","MALE","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32],"Prostate Carcinoma","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","RECRUITING","2026-06-19",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2021-08-05",{"date":41,"type":20},"2028-06-07",{"name":43,"class":44},"M.D. Anderson Cancer Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100594893","phase-2-androgen-deprivation-therapy-relugolix-for-the-improvement-of-diagnostic-imaging-psma-petct-scan-in-patients-with-high-risk-or-very-high-risk-prostate-cancer-the-enrichpsma-trial-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":54,"type":20},30,[23],"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.",[58,27,28,59],"Prostate Adenocarcinoma","Stage IV Prostate Cancer AJCC v8","2026-03-12",{"date":62,"type":37},"2026-03-13",{"date":64,"type":37},"2025-08-25",{"date":66,"type":20},"2026-12-31",{"name":68,"class":44},"Mayo Clinic",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":45},"100541510","phase-2-effects-of-relugolix-vs-leuprolide-on-cardiac-function-in-patients-with-prostate-cancer-100541510","NCT06330805","Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer","A Comparison of Orgovyx (Relugolix) vs Eligard (Leuprolide) on Cardiovascular Function and Biomarkers During Standard of Care Combined ADT (Androgen Deprivation Therapy)-Radiation for Prostate Cancer","Inclusion Criteria:\n\n* Pathologically proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration.\n* Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:\n\n  * Has at least one intermediate risk factor (IRF):\n\n    * Prostate-specific antigen (PSA) 10-20 ng\u002FmL\n    * Clinical stage tumor (T)2b-c (digital rectal exam \\[DRE\\] and\u002For imaging) by American Joint Committee on Cancer (AJCC) 8th edition\n    * Gleason Score 7 (Gleason 3+4 or 4+3 \\[International Society of Urological Pathology \\[ISUP\\] grade group 2-3\\])\n  * Has one or more of the following \"unfavorable\" intermediate-risk designators:\n\n    * \\> 1 IRF\n    * Gleason 4+3=7 (ISUP grade group 3)\n    * ≥ 50% of biopsy cores positive\n\n      * Biopsies may include \"sextant\" sampling of right\u002Fleft regions of the prostate, often labeled base, mid-gland and apex. All such \"sextant\" biopsy cores should be counted. Men may also undergo \"targeted\" sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s).\n    * Absence of high-risk features\n* Appropriate stage based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 120 days prior to registration\n  * Negative bone imaging (M0) with Tc-99m bone scan or fluciclovine (18F) sodium fluoride (NaF) positron emission tomography (PET) within 120 days prior to registration\n  * Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +\u002F- abdominal CT or MRI), within 120 days prior to registration (lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.0 cm in short axis and\u002For if biopsy is negative)\n  * Prostate specific membrane antigen (PSMA) or fluciclovine PET negative for nodal or distant metastatic disease is an acceptable substitute for the above bone and pelvic imaging\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 120 days prior to registration.\n* Non-castrate testosterone level (\\> 50 ng\u002FdL) within 120 days prior to registration.\n* Absolute neutrophil ≥ 1,000 cells\u002Fmm\\^3 (within 120 days prior to registration)\n* Hemoglobin ≥ 10 g\u002FdL (within 120 days prior to registration)\n* Platelet count ≥ 100,000 cells\u002Fmm\\^3 (within 120 days prior to registration)\n* Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin estimated by Cockcroft-Gault Equation (within 120 days prior to registration)\n\n  * For African American patients, CrCl ≥ 30 mL\u002Fmin is estimated by the alternative formula that takes race into account\n* Total bilirubin: 1.5 ≤ institutional upper limit of normal (ULN) (within 120 days prior to registration)\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN (within 120 days prior to registration)\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility for this protocol.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\nNote: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).\n\n* For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n  * Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy.\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.\n\nExclusion Criteria:\n\n* Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, High-intensity focused ultrasound (HIFU), laser thermal ablation, etc.) for prostate cancer.\n* Definitive clinical or radiologic evidence of metastatic disease (M1).\n* Prior invasive malignancy (except non-melanomatous skin cancer) or hematologic malignancy unless disease free for a minimum of 3 years.\n* Prior radiotherapy to the prostate\u002Fpelvis region that would result in overlap of radiation therapy fields.\n* Previous bilateral orchiectomy.\n* Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed.\n* Prior use of 5-alpha-reductase inhibitors is allowed; however, it must be stopped ≥ 30 days prior to the pre-registration PSA measure for determining enrollment eligibility.\n* Prior testosterone replacement therapy is allowed; however, any replacement therapy must be stopped for at least 1 year prior to registration.\n* Severe, active co-morbidity defined as follows:\n\n  * Current\u002Funcontrolled angina or arrhythmias\n  * New York Heart Association Functional Classification II-IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  * History of any condition that in the opinion of the investigator, would preclude participation in this study\n* Patients with significant obstructive urinary symptoms that are suspected to be secondary to prostate cancer and\u002For benign prostatic hypertrophy.\n* Disabilities that prevent performing moderate intensity exercise test with exercise (treadmill) stress test and muscle function tests (walking\u002Fgait assessments and grip strength).\n* Patients unable to tolerate MRI (e.g. claustrophobia), has contraindications to MRI (e.g. metals and implants incompatible with MRI), body habitus preventing MRI scanning, or allergy to gadolinium-based contrast.\n* Significant uncontrolled gastrointestinal (e.g. Crohn's disease, ulcerative colitis) or metabolic disease (e.g. diabetes, hyperlipidemia).\n* Active inflammatory or immune-related disease treated with steroids or immunosuppressive agents.\n* Inability to swallow oral pills.\n* High risk features, which includes any of the following:\n\n  * Gleason 8-10 \\[ISUP grade group 4-5\\]\n  * PSA\\>20\n  * cT3-4 by digital exam OR gross extra-prostatic extension on imaging \\[indeterminate MRI evidence will not count and the patient will be eligible\\]",{"count":77,"type":20},70,[23],"This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.\n\nParticipants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:\n\n1. Comprehensive cardiac and exercise testing before and after starting ADT\n2. Completion of quality-of-life questionnaires at specific intervals during the study period\n3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers",[58,81,27],"Stage IIB Prostate Cancer AJCC v8","2026-03-05",{"date":84,"type":37},"2026-03-09",{"date":86,"type":37},"2024-08-12",{"date":88,"type":20},"2027-12-31",{"name":90,"class":44},"Ohio State University Comprehensive Cancer Center",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"100531862","phase-3-sbrt-versus-hypofractionated-radiotherapy-for-biochemically-recurrent-or-oligometastatic-prostate-adenocarcinoma-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":99,"type":20},118,[101],"PHASE3","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.",[104,105,106,81,27,28,59],"Biochemically Recurrent Prostate Carcinoma","Oligometastatic Prostate Carcinoma","Recurrent Prostate Adenocarcinoma","2026-01-16",{"date":109,"type":37},"2026-01-20",{"date":111,"type":37},"2024-01-22",{"date":113,"type":20},"2030-01-22",{"name":68,"class":44},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":45},"100435087","high-dose-rate-brachytherapy-and-stereotactic-body-radiotherapy-for-the-treatment-of-prostate-adenocarcinoma-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":124,"type":20},52,[126],"NA","This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.",[58,129,27,28,29,30,31,32],"Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","2025-07-11",{"date":132,"type":37},"2025-07-15",{"date":134,"type":37},"2021-08-20",{"date":136,"type":20},"2027-07-01",{"name":138,"class":44},"Jonsson Comprehensive Cancer Center",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":45},"100526062","phase-2-relugolix-in-combination-with-radiation-therapy-for-treating-patients-with-high-risk-prostate-cancer-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":147,"type":20},90,[23],"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.",[27,28,59],"NOT_YET_RECRUITING","2023-11-03",{"date":154,"type":37},"2023-11-13",{"date":156,"type":20},"2023-11-20",{"date":158,"type":20},"2026-10-23",{"name":160,"class":44},"University of Kansas Medical Center"]