[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iiia-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iiia-prostate-cancer-ajcc-v8":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,72,94,116,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100435087","high-dose-rate-brachytherapy-and-stereotactic-body-radiotherapy-for-the-treatment-of-prostate-adenocarcinoma-100435087",false,"NCT04945642","High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma","Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)","HYDRA","Inclusion Criteria:\n\n* Ability to understand a written informed consent document, and the willingness to sign it\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* History\u002Fphysical examination with digital rectal examination of the prostate within 8 weeks prior to registration\n* Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \\> 10, and\u002For Gleason score \\>= 7\n* No evidence of disease beyond the prostate and\u002For seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)\n* Prostate size =\\\u003C 60cc\n* International Prognostic Scoring System (IPSS) score =\\\u003C 15\n* Able to safely receive moderate sedation or general anesthesia\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous\u002Fhematogenous malignancy unless continually disease free for a minimum of 5 years\n* Regional lymph node involvement\n* Evidence of distant metastases\n* Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer\n* Previous pelvic irradiation or prostate brachytherapy\n* Previous or concurrent cytotoxic chemotherapy for prostate cancer\n* Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery\n* Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment","MALE","18 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33,34],"Prostate Adenocarcinoma","Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","RECRUITING","2026-08-18",{"date":38,"type":39},"2026-08-20","ACTUAL",{"date":41,"type":39},"2021-08-20",{"date":43,"type":21},"2028-07-01",{"name":45,"class":46},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100651975","magnetic-resonance-guided-stereotactic-body-radiation-therapy-for-the-treatment-of-prostate-cancer-100651975","NCT07769372","Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Prostate Cancer","A Pilot Study of Focal Magnetic Resonance (MR)-Guided Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For Legally Authorized Representative\n\n  * Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* National Comprehensive Cancer Network (NCCN) low-risk or intermediate-risk prostate cancer, defined as:\n\n  * Low-risk: Prostate-specific antigen (PSA) \\\u003C 10 ng\u002FmL AND grade group 1 (Gleason score 3+3) AND clinical stage T1-T2a\n  * Intermediate-risk (one or more of the following intermediate risk factors \\[IRFs\\]): PSA 10-20 ng\u002FmL, grade group 2 or 3 (Gleason 3+4 or 4+3), or clinical stage T2b-T2c\n\n    * Favorable intermediate-risk (all of the following): 1 IRF, grade group 1 or 2, \\\u003C 50% cores positive\n    * Unfavorable intermediate-risk (one or more of the following): 2 or 3 IRFs, grade group 3, ≥ 50% cores positive\n\n      * Biopsies from a single region of interest (ROI) are counted as a single sample\n* Diagnostic multiparametric MRI (mpMRI) of the prostate (within 6 months prior to enrollment) with MRI-visible dominant lesion defined as Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3\n* Prostate biopsy, including targeted and systematic biopsy. All PI-RADS ≥ 3 lesions must be sampled by MRI-targeted biopsy. Biopsy results must confirm concordance between the MRI-visible lesion and histologically confirmed prostate adenocarcinoma. Patients with any positive biopsy core (any grade group) from a region not attributable to the MRI-defined PI-RADS ≥ 3 lesion(s) are excluded\n* Unilateral disease, defined as: the MRI-visible dominant lesion(s) and all biopsy-confirmed prostate cancer confined to one prostatic lobe. Multiple lesions are permitted provided they can be encompassed within a single focal treatment planning volume\n* Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy\n* Current or planned androgen deprivation therapy (ADT), including leutenizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, antiandrogens, or prior bilateral orchiectomy. Prior 5-alpha reductase inhibitor use is permitted if discontinued ≥ 90 days prior to baseline PSA assessment or if the corrected PSA value (measured PSA × 2) meets protocol risk group eligibility criteria (≤ 20 ng\u002FmL)\n* Prior focal therapy for prostate cancer, including but not limited to high intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), laser ablation, or photodynamic therapy\n* Prior pelvic radiation therapy\n* Prior prostate procedures for BPH (including but not limited to transurethral resection of the prostate \\[TURP\\], UroLift, Aquablation, Rezūm, prostate artery embolization) that, in the opinion of the treating radiation oncologist, have significantly altered prostatic anatomy such that focal SBRT treatment planning would be compromised or leads to increased risk of treatment-related toxicity\n* For patients with severe baseline lower urinary tract symptoms (International Prognostic Scoring System \\[IPSS\\] ≥ 20), the treating radiation oncologist should confirm that the patient's baseline urinary function and location\u002Fvolume of target does not, in their clinical judgment, represent an unacceptable risk for treatment-related urinary morbidity\n* Clinically significant uncontrolled illness. Patients that are known to be HIV-infected that are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patient has baseline grade ≥ 3 gastrointestinal (GI) or genitourinary (GU) toxicity\n* History of prior rectal surgery (e.g., low anterior resection, abdominoperineal resection) or other pelvic surgery that, in the opinion of the treating radiation oncologist, would significantly alter normal pelvic anatomy and compromise safe treatment delivery\n* Active inflammatory bowel disease (ulcerative colitis or Crohn's disease) involving the rectum or sigmoid colon\n* Contraindication to magnetic resonance imaging, including but not limited to:\n\n  * Implanted metallic devices not certified as MRI-conditional (e.g., non-MRI-conditional cardiac pacemakers, defibrillators, neurostimulators, cochlear implants, metallic foreign bodies)\n  * Severe claustrophobia not manageable with anxiolytic medication and\u002For supportive measures\n  * Inability to tolerate supine positioning for the duration of MR-guided treatment delivery (approximately 30-45 minutes per fraction)\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":56,"type":21},20,[24],"This clinical trial studies the side effects and how well magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer. 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. MR-guided SBRT uses magnetic resonance imaging (MRI) to define and localize the area to be treated, which may help provide more accurate delivery of SBRT and lower side effects. MR-guided SBRT may be safe, tolerable, and\u002For effective in treating patients with prostate cancer.",[60,61,31,32,34],"Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","NOT_YET_RECRUITING","2026-08-14",{"date":65,"type":39},"2026-08-17",{"date":67,"type":21},"2027-01-01",{"date":69,"type":21},"2029-03-09",{"name":71,"class":46},"City of Hope Medical Center",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":47},"100521259","phase-2-hormone-therapy-apalutamide-and-image-guided-stereotactic-body-radiation-therapy-for-the-treatment-of-patients-with-prostate-cancer-heatwave-trial-100521259","NCT06067269","Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial","High Precision Stereotactic Radiotherapy to the Whole Prostate With Focal Boost and Varying Hormonal Therapy (HEATWAVE)","HEATWAVE","Inclusion Criteria:\n\n* Confirmed diagnosis of prostate adenocarcinoma\n* Age ≥ 18\n* Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \\[a\\] 2 of the following: PSA 10-20 ng\u002FmL, clinical T category 2b-2c, or International Society of Urological Pathology \\[ISUP\\] grade group 2; \\[b\\] OR any 1 of \\[a\\] with ISUP grade group 3 disease; OR \\[c\\] any 1 of \\[a\\] with 50% or more cores on systematic biopsy showing prostate cancer)\n* Have a Decipher genomic classifier score\n* Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \\[PI-RADS\\] version 2.1 score 4 or 5)\n* Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography\u002Fcomputed tomography (PET\u002FCT)\n* Have total testosterone \\>= 150 ng\u002FdL\n* Adequate performance status (Eastern Cooperative Oncology Group \\[ECOG\\] 0-1)\n* Hemoglobin ≥ 9.0 g\u002FdL, independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Platelet count ≥ 100,000 x 10\\^9\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to randomization (at screening)\n* Serum albumin ≥ 3.0 g\u002FdL (at screening)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin (at screening)\n* Serum potassium ≥ 3.5 mmol\u002FL (at screening)\n* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\\u003C 2.5 x ULN (at screening)\n* Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry\n\nExclusion Criteria:\n\n* Any evidence of spinal cord compression (radiological or clinical)\n* Prior pelvic malignancy\n* Prior pelvic radiation\n* Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression\n* Inability to undergo radiotherapy, or hormonal therapy\n* Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)\n* Inflammatory bowel disease or active collagen vascular disease\n* History of any of the following:\n\n  * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \\[CNS\\] or meningeal disease which may require treatment with surgery or radiation therapy)\n  * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization\n* Current evidence of any of the following:\n\n  * Uncontrolled hypertension\n  * Gastrointestinal disorder affecting absorption\n  * Known active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n  * Any condition that in the opinion of the investigator would preclude participation in this study\n  * Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered\n  * Baseline moderate and severe hepatic impairment (Child Pugh class B \\& C)",{"count":81,"type":21},95,[83],"PHASE2","This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.",[27,61,31,32],"2026-07-16",{"date":88,"type":39},"2026-07-17",{"date":90,"type":39},"2024-03-28",{"date":92,"type":21},"2027-12-30",{"name":45,"class":46},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":47},"100529790","focal-ablation-with-focal-cryotherapy-or-hifu-for-the-treatment-of-men-with-localized-prostate-cancer-100529790","NCT06178354","Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer","A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer","Inclusion Criteria:\n\n* Ability to understand and willingness to sign an informed consent form\n* Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)\n* Patients ≥ 18 years of age at time of consent\n* Life expectancy ≥ 5 years\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* Nodal or distant metastases\n* Prior treatment for prostate cancer\n* Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study\n* Known contraindications to general anesthesia\n* Uncorrectable coagulopathy\n* Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction\n* Any condition that would prohibit the understanding or rendering of informed consent\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial",{"count":102,"type":21},100,[24],"This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.",[106,60,61,31,32],"Localized Prostate Carcinoma","2026-06-25",{"date":109,"type":39},"2026-06-30",{"date":111,"type":39},"2023-11-09",{"date":113,"type":21},"2029-06",{"name":115,"class":46},"University of California, Davis",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":47},"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","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":124,"type":21},200,[83],"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.",[128,29,30,31,32,33,34],"Prostate Carcinoma","2026-06-19",{"date":131,"type":39},"2026-06-23",{"date":133,"type":39},"2021-08-05",{"date":135,"type":21},"2028-06-07",{"name":137,"class":46},"M.D. Anderson Cancer Center",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":47},"100418222","proton-radiation-therapy-for-the-treatment-of-patients-with-high-risk-prostate-cancer-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":146,"type":21},30,[24],"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.",[30,31,32,33],"2026-02-12",{"date":152,"type":39},"2026-02-17",{"date":154,"type":39},"2021-02-01",{"date":156,"type":21},"2027-12-31",{"name":158,"class":46},"Emory University"]