[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-prostate-cancer-ajcc-v8":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,70,98,122,146,180,200,223,244,265,286,308,333,356,381,404,426],{"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":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100404756","phase-2-measuring-the-effects-of-talazoparib-in-patients-with-advanced-cancer-and-dna-repair-variations-100404756",false,"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","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"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 III Prostate Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","RECRUITING","2026-06-18",{"date":60,"type":61},"2026-06-22","ACTUAL",{"date":63,"type":61},"2021-04-26",{"date":65,"type":20},"2026-12-01",{"name":67,"class":68},"National Cancer Institute (NCI)","NIH",4,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100452216","phase-2-cabozantinib-and-atezolizumab-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-100452216","NCT05168618","Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer","AtezoCab: A Phase II Study of Cabozantinib in Combination With Atezolizumab in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Non-Measurable Disease","AtezoCab","Inclusion Criteria:\n\n* Male subject aged \\>= 18 years\n* Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology\n* Metastatic disease progression after continuous androgen deprivation therapy for hormone sensitive state\n* Patient must have non-measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria. Non-measurable disease can be bone lesions and\u002For extraskeletal disease\n* Disease progression on or after at least one prior novel hormonal therapy (NHT) (defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, darolutamide)\n* Eastern Cooperative Oncology Group (ECOG) performance Status =\\\u003C 2\n* Effective castration with serum testosterone levels =\\\u003C 0.5 ng\u002FmL (=\\\u003C1.7 nmol\u002FL)\n* Tumor tissue available (archival or recent tumor biopsy). If no tumor tissue is available, patients can be enrolled after approval from Principal Investigator.\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 without granulocyte colony-stimulating factor support\n* White blood cell count \\>= 2500\u002FuL\n* Lymphocyte count \\>= 0.5 x 10\\^9\u002FL (500\u002FuL)\n* Platelet count \\>= 100,000\u002Fmm\\^3 without transfusion in the 2 weeks prior to cycle 1 day 1 (C1D1)\n* Hemoglobin \\>= 9 g\u002FdL\n* Serum albumin \\>= 2.5 g\u002Fdl\n* For patients not receiving therapeutic anticoagulation: prothrombin time (PT)\u002FInternational normalized ratio (INR) or partial thromboplastin time (PTT) test \\\u003C 1.5 x institutional upper limit of normal (ULN). For patients receiving therapeutic anticoagulation: stable anticoagulant regimen as determined by Investigator\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN). For subjects with Gilbert's disease =\\\u003C 3 x institutional ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 × institutional ULN\n\n  * Subjects with liver metastases will be allowed to enroll with AST and ALT levels =\\\u003C 5 x institutional ULN\n* Alkaline phosphatase (ALP) =\\\u003C 3 × institutional ULN. Patients with documented liver or bone metastases: ALP =\\\u003C 5 x institutional ULN\n* Serum creatinine =\\\u003C 1.5 x institutional ULN or calculated creatinine clearance \\>= 40 mL\u002Fmin by Cockcroft-Gault formula\n* Urine protein\u002Fcreatinine ration (UPCR) =\\\u003C 1mg\u002Fmg (=\\\u003C 113.2 mg\u002Fmmol), or 24-hour (h) urine protein =\\\u003C 1 g\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of study treatment\n* Male subjects must agree to use a condom during intercourse for the duration of study therapy\n* Recovery to baseline or =\\\u003C grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator and\u002For stable on supportive therapy\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\n* Capable of understanding and complying with the protocol requirements\n\nExclusion Criteria:\n\n* Prior chemotherapy in the metastatic castration refractory prostate cancer setting is not allowed (taxane-based in metastatic castration-sensitive disease is allowed)\n* Prior treatment with cabozantinib, CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-a, anti-PD1 and anti-PD-L1 therapeutic antibodies\n* Prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Receiving other investigational agents\n* Patients with measurable disease outside the pelvis (above aortic bifurcation) per RECIST 1.1 criteria\n* History of Leptomeningeal disease\n* Uncontrolled tumor-related pain\n\n  * Note: Patients requiring pain medication must be on a stable regimen at study entry\n  * Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation\n  * Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible\n* Major surgery (e.g., laparoscopic nephrectomy, gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 4 weeks before first dose of study treatment or anticipation of need for a major surgical procedure during the study. Minor surgeries within 10 days before first dose of study treatment. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \\[OS\\] rate \\> 90%), such as locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast\n* Known brain metastases or cranial epidural disease\n\n  * Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment after radiotherapy or at least 4 weeks prior to the first dose of study treatment after major surgery (e.g. removal or biopsy of brain metastasis) will be allowed on trial. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines), low-dose low molecular weight heparins (LMWH), or prophylactic dose of anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban.\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 30 days before first dose of any study treatment and for 5 months after the last dose of any study treatment\n* Current evidence of uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class II, III or IV, unstable angina pectoris, serious unstable cardiac arrhythmias\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before the first dose of study treatment\n\n      * Subjects with a diagnosis of incidental, sub segmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation for at least 1 week before first dose of study treatment\n    * Uncontrolled hypertension defined as persistent systolic blood pressure (BP) \\> 150 mm Hg or diastolic BP \\> 90 mm Hg despite optimal antihypertensive treatment\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    * The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction\n    * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation\n* Lesions invading or encasing any major blood vessels\n* Any active or history of known or suspected autoimmune disease as determined to be clinically significant by treating investigator's clinical judgement will be excluded , including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis (see Appendix for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\n  * Controlled Type 1 diabetes mellitus who are an insulin regimen\n  * Autoimmune-related hypothyroidism who are on thyroid replacement hormone\n  * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months\n  * Conditions not expected to recur in the absence of an external trigger\n* Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained\n  * Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n  * Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Any active infection requiring systemic treatment.\n\n  * Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) or oral valacyclovir (valaciclovir) are eligible for the study\n* Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection. Note: Subjects on effective HIV antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture\n* Malabsorption syndrome\n* Uncompensated\u002Fsymptomatic hypothyroidism\n* Moderate to severe hepatic impairment (Child-Pugh B or C)\n* Requirement for hemodialysis or peritoneal dialysis\n* History of solid organ or allogenic stem cell transplant\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n  * Note: Patients with indwelling catheters (e.g., PleurX) are allowed\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment. Furthermore, subjects with a history of additional risk factors for Torsades de pointes (e.g., long QT syndrome) are also excluded.\n\n  * Note: If a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n* Inability to swallow tablets or unwillingness or inability to receive IV administration\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3). Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are also excluded\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study\n* Subjects taking prohibited medications as described in Section 6. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment","MALE",{"count":80,"type":20},33,[23],"This phase II trial tests whether cabozantinib and atezolizumab work to shrink tumors in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and atezolizumab may kill more tumor cells in patients with metastatic castrate-resistant prostate cancer.",[28,84,56,85,86],"Metastatic Prostate Adenocarcinoma","Stage IVA Prostate Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","2026-06-04",{"date":89,"type":61},"2026-06-05",{"date":91,"type":61},"2022-03-29",{"date":93,"type":20},"2027-01",{"name":95,"class":96},"University of Utah","OTHER",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100442721","early-phase-1-immunological-effects-of-vitamin-d-replacement-among-blackafrican-american-prostate-cancer-patients-100442721","NCT05045066","Immunological Effects of Vitamin D Replacement Among Black\u002FAfrican American Prostate Cancer Patients","MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black\u002F African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease","Inclusion Criteria:\n\n* Pre-Registration:\n\n  * African American males, age \\>= 18 years\n  * Patients with a previous history of localized or metastatic or locally recurrent prostate cancer\n* Registration:\n\n  * Patients with Vitamin D levels below 30 ng\u002Fml\n\nExclusion Criteria:\n\n* Pre-Registration:\n\n  * Known hypersensitivity to vitamin D\n  * End stage renal failure on dialysis\n  * Liver cirrhosis\n  * Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU\u002F10mcg of vitamin D daily for the past month\n  * Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature\n  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection\n  * History of hypercalcemia\n* Registration:\n\n  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection",{"count":106,"type":20},220,[108],"EARLY_PHASE1","This early phase I is to find out how common vitamin D insufficiency is among African American patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin D insufficiency affects the immune system. This study also aims to find out if replacing vitamin D results in normalization of the immune function. Information from this study may benefit prostate cancer patients by identifying vitamin D insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.",[111,56,112,43],"Localized Prostate Carcinoma","Locally Recurrent Prostate Carcinoma",{"date":114,"type":61},"2026-06-08",{"date":116,"type":61},"2021-12-29",{"date":118,"type":20},"2029-08-31",{"name":120,"class":96},"Mayo Clinic",2,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":97},"100487448","extending-prostate-genetic-awareness-navigation-and-delivery-the-expand-network-100487448","NCT05627219","Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network","Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network","Inclusion Criteria:\n\n* AIM 1: Are 18 years old or older\n* AIM 1: Are able to read and speak English comfortably\n* AIM 1: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience\n* AIM 2: Are 18 years old or older\n* AIM 2: Are African American\n* AIM 2: Are able to read and speak English comfortably\n* AIM 2: Men who meet any one of the following criteria: (1) metastatic prostate cancer; (2) prostate cancer with high-risk features (T3 or higher, Gleason 8 or higher, node positive disease); (3) with or without a diagnosis of prostate cancer with strong family history (2 or more first-degree or second-degree relatives) with prostate cancer (particularly metastatic prostate cancer or died from prostate cancer), breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer\n\nExclusion Criteria:\n\n* Patients that do not meet the inclusion criteria\n* Children under the age of 18\n* Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process",true,{"count":131,"type":20},30,"OBSERVATIONAL","This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.",[43,135,136,56],"Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","2026-05-12",{"date":139,"type":61},"2026-05-15",{"date":141,"type":61},"2024-06-03",{"date":143,"type":20},"2026-09-30",{"name":145,"class":96},"Thomas Jefferson University",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":97},"100415725","cryoablation-combined-with-stereotactic-body-radiation-therapy-for-the-treatment-of-painful-bone-metastases-the-crome-trial-100415725","NCT04693377","Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial","Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases","Inclusion Criteria:\n\n* Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha\u002Fbeta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma\n* A target lesion the meets the following criteria:\n\n  * The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs)\n  * The target lesion must be =\\\u003C 7cm\n  * The pain due to the target lesion must be at least 4\u002F10 based on the BPI pain scale\n  * Pain from the metastatic site must correlate with an identifiable tumor on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) imaging\n* Life expectancy \\>= 3 months\n* Platelet count \\> 50,000\u002Fmm\\^3 within 6 weeks of screening\n* International normalized ratio (INR) \\\u003C 1.5 within 6 weeks of screening\n* If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin \\[LMWH\\] preparations)\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%) within 6 weeks of screening\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization\n* All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery\n* Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator\n* Target lesions that involve the spinal column or calvarium\n* Absolute neutrophil count \\\u003C 1000 mm\\^3 within 6 weeks of screening\n* Active infection\n* Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization\n* Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing \\> 50% loss of cortical bone. Lesions involving the hands and feet",{"count":154,"type":20},40,[156],"NA","This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Bone is a common site of metastasis in advanced cancer, and bone metastases often result in debilitating cancer-related pain. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.",[28,159,160,40,161,43,162,163,164,165,166,56,167,168,85,169,86,170],"Metastatic Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Bone","Metastatic Melanoma","Metastatic Renal Cell Carcinoma","Metastatic Sarcoma","Metastatic Thyroid Gland Carcinoma","Metastatic Urothelial Carcinoma","Stage IV Colorectal Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2026-04-10",{"date":173,"type":61},"2026-04-15",{"date":175,"type":61},"2021-03-16",{"date":177,"type":20},"2027-04-01",{"name":179,"class":96},"M.D. Anderson Cancer Center",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":97},"100476738","peer-navigation-for-the-support-of-metastatic-prostate-cancer-patients-undergoing-genetic-evaluation-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":188,"type":20},120,[156],"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.",[43,53,56],"2026-04-09",{"date":194,"type":61},"2026-04-14",{"date":196,"type":61},"2025-01-01",{"date":198,"type":20},"2026-09",{"name":145,"class":96},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":97},"100447983","phase-1-abemaciclib-before-177lu-psma-617-for-the-treatment-of-metastatic-castrate-resistant-prostate-cancer-100447983","NCT05113537","Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer","Phase I\u002FII Study of CDK4\u002F6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy","UPLIFT","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation.\n2. Age \\>= 18 years.\n3. Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria.\n4. Patients must have adenocarcinoma histology.\n5. Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc.\n6. Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n7. Patients must have a 68Ga-PSMA-11 PET scan with at least one PSMA-positive lesions (maximum standardized uptake value \\[SUVmax\\] greater than SUVmax of liver) as determined by nuclear medicine review prior to start of lead-in treatment with abemaciclib\n8. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2\n9. Patients must have life expectancy of \\> 6 months\n10. Patients must have adequate organ function as outlined below and bone marrow reserve\n\n    * White blood cell (WBC) \\> 2.5\n    * Absolute neutrophil count (ANC) \\> 1.5\n    * Hemoglobin (Hgb) \\>= 8.0 \\[Note- Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\\]\n    * Platelets (Plt) \\>= 100 x 10\\^9\u002FLiter (100,000\u002FMicroliter)\n    * Total bilirubin =\\\u003C 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =\\\u003C 2 ULN and direct bilirubin within normal limits is permitted\n    * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Creatinine =\\\u003C 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation.\n11. Patient must be able to swallow oral medications\n12. Patients must have the ability to understand a written informed consent document, and the willingness to sign it\n13. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n14. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n15. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n16. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n17. Patients with reproductive potential must agree to use effective contraception and to not donate sperm during the study and for at least 2 months following the last dose of study treatment. Effective method of contraception means male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, or cervical cap with spermicide\n\nExclusion Criteria:\n\n1. Patients with small cell or neuroendocrine carcinoma histology.\n2. Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake relative to soft tissue\n3. Patients with prior treatment with CDK4\u002F6 inhibitors\n4. Patients with prior treatment with PSMA-targeted radioligand therapy. Patients with previous treatment with PSMA targeting therapies (Such as Chimeric antigen receptor T cells (CAR-T) or Bi-specific T-cell engagers (BiTEs) are eligible.\n5. Patients treated with Radium-223 within 6 weeks prior to study entry.\n6. Any systemic anti-cancer therapy within 3 weeks of study entry\n7. Patients who have experienced significant radiation-related adverse events (AEs) from prior radiation treatment (\\>= grade 3) or have experienced persistent radiation-related AEs that have not resolved by the time of study randomization\n8. Patients with a history of central nervous system (CNS) metastases are ineligible unless they have received prior therapy (surgery, radiation therapy (RT), gamma knife) are asymptomatic, and not receiving corticosteroids for this indication. Head imaging is not required\n9. Patients with symptoms of cord compression or impending cord compression\n10. Patients with concurrent serious medical conditions as determined by primary investigator\n11. Patients with other significant malignancies that are expected to alter life expectancy or interfere with disease assessment. Patients with adequately treated skin cancer, non-muscle-invasive bladder cancer and patients with prior history of malignancy who have been disease free for more than 2 years are eligible. Patients with history of in-situ\u002Fearly stage melanoma will not be excluded\n12. Patients who have not recovered from adverse events due to prior anti-cancer therapy to =\\\u003C grade 1 or baseline (other than alopecia or peripheral neuropathy)\n13. Patients with serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n14. The patient has active systemic bacterial infection (requiring intravenous (IV) antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment\n15. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n16. Patients currently receiving any other investigational therapeutic agents.",{"count":131,"type":20},[210,23],"PHASE1","This phase I\u002FII trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.",[28,84,56,85,86,213,214],"Metastatic Castration-resistant Prostate Carcinoma","Metastatic Castration-resistant Prostate Cancer",{"date":216,"type":61},"2026-04-13",{"date":218,"type":61},"2022-07-08",{"date":220,"type":20},"2027-12-31",{"name":222,"class":96},"Vadim S Koshkin",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":97},"100598615","phase-2-evaluating-in-home-cancer-therapy-versus-in-clinic-cancer-therapy-in-black-men-with-locally-advanced-biochemically-recurrent-and-metastatic-prostate-cancer-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":231,"type":20},38,[23],"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.",[235,37,43,53,56],"Biochemically Recurrent Prostate Carcinoma","2026-03-23",{"date":238,"type":61},"2026-03-25",{"date":240,"type":61},"2025-08-27",{"date":242,"type":20},"2028-08-27",{"name":120,"class":96},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":97},"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":131,"type":20},[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.",[255,256,53,56],"Prostate Adenocarcinoma","Stage IIC Prostate Cancer AJCC v8","2026-03-12",{"date":259,"type":61},"2026-03-13",{"date":261,"type":61},"2025-08-25",{"date":263,"type":20},"2026-12-31",{"name":120,"class":96},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":97},"100529406","phase-2-abiraterone-and-prednisone-or-darolutamide-for-the-treatment-of-advanced-prostate-cancer-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":273,"type":20},75,[23],"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.",[277,53,56],"Advanced Prostate Adenocarcinoma","2026-03-11",{"date":259,"type":61},{"date":281,"type":61},"2023-11-09",{"date":283,"type":20},"2027-05",{"name":285,"class":96},"University of California, Davis",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":97},"100418900","phase-2-talazoparib-with-androgen-deprivation-therapy-and-abiraterone-for-the-treatment-of-castration-sensitive-prostate-cancer-100418900","NCT04734730","Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer","Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer","Inclusion Criteria:\n\n* All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. (Note: Gleason score not required if biopsy of metastasis was used to make the histologic diagnosis)\n* All patients must have metastatic disease: either soft tissue and\u002For bony metastases prior to initiation of androgen. Measurable disease is not required\n* Baseline imaging must have been performed within 42 days before or 14 days after initiating luteinizing hormone releasing hormones (LHRH) therapy. All disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Patients may have started on LHRH therapy for metastatic prostate cancer provided this was initiated no longer than 60 days prior to registration\n\n  * Patients may have received neoadjuvant and\u002For adjuvant LHRH therapy during definitive treatment or salvage radiation; if so at least 12 months must have elapsed from the last LHRH injection and baseline testosterone must be \\> 150 ng\u002FdL\n  * No restriction on bicalutamide used for flare prevention or combined therapy however bicalutamide must be stopped at registration\n* Patients must have a Karnofsky performance status of 60 - 100\n* Men of reproductive potential and those who are surgically sterilized (i.e., vasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends\n* Bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (obtained within 28 days prior to registration)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 2.5 x institutional ULN, or =\\\u003C 5 x institutional ULN if liver metastases are present (obtained within 28 days prior to registration)\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin using a serum creatinine obtained within 28 days prior to registration\n* Leukocytes \\>= 3,000\u002FmcL (obtained within 28 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (obtained within 28 days prior to registration)\n* Hemoglobin \\>= 9 g\u002FdL (obtained within 28 days prior to registration)\n* Platelets \\>= 100,000\u002FmcL (obtained within 28 days prior to registration)\n* All subjects must have the ability to understand and the willingness to sign a written informed consent\n* Patients may have received prior androgen deprivation therapy (ADT) -neoadjuvant and\u002For adjuvant, or in conjunction with salvage radiation - but it must not have lasted for more than 36 months. Single or combination therapy allowed. At least 6 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and\u002For adjuvant setting, and serum testosterone must be \\> 150 ng\u002FmL within 28 days prior to registration. Note: Serum testosterone assessment is required for eligibility for only those with prior treatment with ADT\n\n  * Patients who have already started on LHRH therapy are eligible, provided no more than 60 days have elapsed from LHRH injection (or surgical castration) for metastatic prostate cancer prior to registration. The start date of medical castration is considered the day the patient first received an injection of a LHRH agonist\u002Fantagonist (or orchiectomy), not an oral antiandrogen. Subjects may not already be taking abiraterone, enzalutamide, apalutamide or other intensification agent during this time - bicalutamide is permitted\n* Patients may have received palliative radiotherapy for symptomatic bone or visceral metastasis, provided they have recovered from all side effects at the time of registration\n* Patients may have received prior surgery. For all major surgeries, at least 14days must have elapsed since completion and patient must have recovered from all major side effects of surgery per investigator's assessment\n* Patients may have received or plan to receive concurrent bone targeting agents that do not have an effect on prostate specific antigen (PSA) (e.g. denosumab or bisphosphonate)\n\nExclusion Criteria:\n\n* Patients must not have received prior and\u002For must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed\n* Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer\n\n  * Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting may be allowed at the discretion of the principal investigator. At least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and\u002For adjuvant setting\n* Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. But, if brain imaging studies are performed, they must be negative for disease\n* Patients must not have New York Heart Association class III or IV heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration\n* Patients must not have uncontrolled hypertension (defined as blood pressure \\> 160 mmHg systolic and \\> 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart) despite appropriate medical therapy. Note: Patients may be rescreened after adjustments of antihypertensive medications\n* Patients must not be known to have human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study\n* Patients with a known history of primary and secondary adrenal insufficiency are not eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs\n* Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. Previous experimental therapy must have been completed at least 28 days prior to registration\n* Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of any of the study drugs, including difficulty swallowing oral medications\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years",{"count":294,"type":20},70,[23],"This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Androgen can cause the growth of prostate tumor cells. Degarelix, leuprolide acetate, bicalutamide, goserelin acetate, and abiraterone lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Giving talazoparib with androgen deprivation therapy and abiraterone may improve cancer control for patients with castration sensitive prostate cancer.",[298,84,56,85,86],"Castration-Sensitive Prostate Carcinoma","2026-01-27",{"date":301,"type":61},"2026-01-28",{"date":303,"type":61},"2021-05-04",{"date":305,"type":20},"2027-08-23",{"name":307,"class":96},"City of Hope Medical Center",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":317,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"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":316,"type":20},118,[318],"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.",[235,321,322,323,256,53,56],"Oligometastatic Prostate Carcinoma","Recurrent Prostate Adenocarcinoma","Stage IIB Prostate Cancer AJCC v8","2026-01-16",{"date":326,"type":61},"2026-01-20",{"date":328,"type":61},"2024-01-22",{"date":330,"type":20},"2030-01-22",{"name":120,"class":96},6,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":78,"minAge":340,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":97},"100506076","phase-2-bright-white-light-therapy-in-reducing-cancer-related-fatigue-and-depression-in-advanced-prostate-cancer-patients-undergoing-treatment-with-adt-combination-therapy-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":342,"type":20},210,[23],"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.",[346,43,347,53,56],"Advanced Prostate Carcinoma","Prostate Carcinoma","2025-10-02",{"date":350,"type":61},"2025-10-06",{"date":352,"type":61},"2024-07-09",{"date":354,"type":20},"2028-11-30",{"name":307,"class":96},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":21,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":380},"100337790","phase-3-standard-systemic-therapy-with-or-without-definitive-treatment-in-treating-participants-with-metastatic-prostate-cancer-100337790","NCT03678025","Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer","Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer","Inclusion Criteria:\n\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma\\* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (\\*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound \\[HIFU\\], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride \\[NaF\\], prostate-specific membrane antigen \\[PSMA\\], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid \\[FACBC\\], carbon \\[C\\]11) but not conventional imaging (technetium \\[Tc\\]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.\n* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.\n* STEP 1 REGISTRATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.\n* STEP 1 REGISTRATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.\n* STEP 1 REGISTRATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.\n* STEP 1 REGISTRATION: CLINICAL\u002FLABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.\n* STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.\n* STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.\n* STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.\n* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =\\\u003C grade 1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) prior to randomization.\n* STEP 2 RANDOMIZATION: PRIOR\u002FCONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=\\\u003C 4 sites). All treatment must be completed prior to randomization.\n* STEP 2 RANDOMIZATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.\n* STEP 2 RANDOMIZATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a testosterone \\\u003C 50 ng\u002FdL within 28 days prior to randomization.\n* STEP 2 RANDOMIZATION: CLINICAL\u002FLABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.",{"count":364,"type":20},1273,[318],"This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.",[368,369,56,85,86],"Castration Levels of Testosterone","Metastatic Prostatic Adenocarcinoma","2025-09-04",{"date":372,"type":61},"2025-09-11",{"date":374,"type":61},"2018-09-24",{"date":376,"type":20},"2031-10-01",{"name":378,"class":379},"SWOG Cancer Research Network","NETWORK",338,{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":21,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":97},"100432776","phase-2-extremely-hypofractionated-intensity-modulated-stereotactic-body-radiotherapy-for-the-treatment-of-prostate-cancer-with-rising-psa-after-radical-prostatectomy-100432776","NCT04915508","Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy","Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)","EXCALIBUR","Inclusion Criteria:\n\n* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent\n* Presence of any ONE of the following:\n\n  * Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)\n  * Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng\u002FmL\n  * Intermediate- or high-risk Decipher genomic classifier score\n  * Identification of prostate cancer in \\>= 1 lymph node at the time of prostatectomy (pN+ disease)\n* CT scan and MRI of the pelvis within 120 days prior to enrollment \\[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \\\u003C 1.0 ng\u002FmL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\\]\n* Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \\> 1.0 ng\u002FmL\n* Age \\>= 18\n* Karnofsky performance status (KPS) \\>= 70 and\u002For Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Ability to understand, and willingness to sign, the written informed consent\n\nExclusion Criteria:\n\n* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* Prior pelvic radiotherapy\n* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia",{"count":390,"type":20},102,[23],"This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. 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. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.",[255,394,136,56,85,86],"Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8","2025-06-17",{"date":397,"type":61},"2025-06-22",{"date":399,"type":61},"2021-06-23",{"date":401,"type":20},"2027-08-01",{"name":403,"class":96},"Jonsson Comprehensive Cancer Center",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":21,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":416,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":97},"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":412,"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.",[256,53,56],"NOT_YET_RECRUITING","2023-11-03",{"date":419,"type":61},"2023-11-13",{"date":421,"type":20},"2023-11-20",{"date":423,"type":20},"2026-10-23",{"name":425,"class":96},"University of Kansas Medical Center",{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":78,"minAge":17,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":21,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":97},"100443430","phase-2-modifying-metabolic-syndrome-and-cardiovascular-risk-for-prostate-cancer-patients-on-adt-using-a-risk-factor-modification-program-and-continuous-fitbit-monitoring-100443430","NCT05054296","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \\[CT\\] and\u002For magnetic resonance imaging \\[MRI\\]) or biochemical recurrence\u002Frefractoriness following local therapy (prostatectomy or radiation)\n* Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months\n* On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months\n* Combination ADT with abiraterone or enzalutamide is permitted\n* Anticipation to remain hypogonadal for at least 6 months subsequently\n* Asymptomatic bone metastasis is permissible (exercise will be modified and patients monitored)\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol \\^70 supervised by a cardiologist\n* Hemoglobin \\>= 9.0 g\u002FdL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Platelet count \\>=75,000\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Access to a smart phone with android or iPhone OS (iOS) operating systems\n* Able to speak and comprehend English\n\nExclusion Criteria:\n\n* Current use of any other systemic therapy for prostate cancer with the exception of gonadotrophin releasing hormone (GnRH) agonists\u002Fantagonists, abiraterone, enzalutamide, bisphosphonates or RANK-ligand inhibitors (for bone metastases) which are allowed\n* Any underlying comorbid medical or psychiatric condition, which in the opinion of the Investigator, will make participation in our exercise intervention hazardous or obscure the interpretation of adverse events\n* Inability to walk 400 meters or undertake upper and lower limb exercise, and resistance training in the previous 3 months\n* Chemotherapy treatment within 28 days of study enrollment\n* Symptomatic bone metastasis\n* Any investigational pharmaceutical products\n* Radiation therapy or surgical intervention for prior bone metastasis\n* Clinically significant active malignancy other than prostate cancer\n* Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\\>= 450 m\u002Fsec)\n* Clinically significant heart disease that may impact safety of independent or supervised exercise including preexisting coronary artery disease, myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of \\\u003C 40% at baseline\n* Untreated symptomatic spinal cord compressions\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",{"count":434,"type":20},200,[23],"This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.",[235,84,56,85,86],"2023-03-28",{"date":440,"type":61},"2023-03-29",{"date":442,"type":61},"2020-03-23",{"date":444,"type":20},"2027-02-02",{"name":179,"class":96}]