[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"castrate-sensitive-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:castrate-sensitive-prostate-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,84,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644944","early-phase-1-response-with-interim-psma-pet-in-metastatic-castration-sensitive-prostate-cancer-for-optimization-of-adaptive-metastasis-directed-radiotherapy-delivery-100644944",false,"NCT07674771","Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery","RIPCORD","Inclusion Criteria:\n\n1. History of pathologically confirmed prostate cancer.\n2. Age \\>=18 years.\n3. Performance status ECOG 0-2.\n4. Staging 68Ga PMSA-11 PET\u002FCT showing 4-20 sites of metastasis from prostate cancer within \\\u003C=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).\n5. At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.\n6. All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n7. Ability to understand and the willingness to sign a written informed consent.\n8. Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).\n\nExclusion Criteria:\n\n1. Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.\n2. Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.\n3. Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.\n4. Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.\n5. History of allergic reactions to PMSA-11 68Ga imaging agent.\n6. Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements.","MALE","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.",[26,27,28],"Castrate Sensitive Prostate Cancer","Prostate Cancer","Metastasis Castration Resistant Prostate Cancer(mCRPC)",[30,31,32,33,34],"metastatis","poly-metastatic","prostate cancer","castration sensitive","radiotherapy","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":20},"2026-07-15",{"date":43,"type":20},"2029-06-15",{"name":45,"class":46},"University of Texas Southwestern Medical Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100471748","phase-2-abiraterone-enzalutamide-or-apalutamide-in-castrate-sensitive-prostate-cancer-100471748","NCT05422911","Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.","A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer","Inclusion Criteria:\n\n* Veterans must meet the following to be eligible to participate:\n* Be willing and able to provide written informed consent for the trial.\n* Age ≥18 years of age on day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n* Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n* Laboratory tests meet minimum safety requirements:\n\n  * Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) \\[except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN\\].\n  * Renal: Creatinine clearance ≥30 ml\u002Fmin or serum creatinine ≤1.8 mg\u002Fdl\n  * Hematological: Platelet count ≥100,000\u002Fmm\\^3; Hemoglobin \\>9 g\u002FdL; ANC \\>1 X10\\^9\u002FL\n  * Serum potassium \\>3 mEq\u002FL\n\nExclusion Criteria:\n\nSubjects with any of the following will not be enrolled:\n\n* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).\n* Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist\u002Fantagonist therapy) within 4 weeks of randomization.\n* History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).\n* Patients who are receiving any other investigational agents concurrently.\n* Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.\n* Child-Pugh Class B and C",{"count":56,"type":20},192,[58],"PHASE2","The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent and uniform across the US. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\n\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.",[61,62,63,64],"Metastatic Cancer","Neoplasm, Prostate","Castrate-sensitive","Castrate-sensitive Prostate Cancer",[66,67,68,69,70,71],"YONSA","zytiga","enzalutamide","apalutamide","growth rate","doubling time","RECRUITING","2026-06-10",{"date":75,"type":39},"2026-06-15",{"date":77,"type":39},"2022-08-31",{"date":79,"type":20},"2027-12-31",{"name":81,"class":82},"Sun Pharmaceutical Industries Limited","INDUSTRY",12,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":47},"100549115","remotely-monitored-exercise-interventions-in-patients-with-mcspc-undergoing-adt-prostate-006-100549115","NCT06429813","Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)","A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory\u002FMuscular Fitness and Fatigue in Patients With Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment With Androgen-deprivation Therapy (ADT) Intensification","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male, aged ≥18 years old\n4. Diagnosis of mCSPC (defined as either biopsy-proven metastatic prostate cancer or elevated PSA (Prostate Specific Antigen) in the setting of imaging findings typical of prostate cancer spread; patients can either have de novo metastatic disease or recurrent metastatic disease after prior definitive therapy to the primary tumor with either surgery or radiation)\n5. Planned treatment with ADT (LHRH \\[Luteinizing hormone-releasing hormone\\] agonist such as leuprolide or LHRH antagonist such as degarelix), or recent administration, ≤14 days prior to enrollment.\n6. Planned intensification with ARSI (abiraterone\u002Fprednisone, enzalutamide, apalutamide, or darolutamide).\n7. Oncologist clearance for exercise training after taking into account functional status and co-morbid conditions that may limit ability to participate.\n8. Ability to take oral medication and willing to adhere to the study intervention regimen\n9. Ability to read, speak, and understand English.\n\nExclusion Criteria:\n\n1. Castrate-resistant prostate cancer (defined as prostate cancer previously treated with a backbone of ADT hormonal therapy with either progression of disease on imaging PSA progression with PSA increase of \\> 25% and 2 ng\u002FmL above nadir, confirmed at 2 time points at least 3 weeks apart, in the setting of testosterone level \\\u003C 50)\n2. Patients with prostate cancer with biochemical recurrence (e.g., received prior definitive therapy with subsequent PSA \\[Prostate-Specific Antigen\\] rise) but radiographic imaging is negative for metastatic disease\n3. Metastatic bone lesion(s) in the proximal femur, bone lesion causing impending fracture, or other metastatic site deemed unsafe for walking by treating physician\n4. Medical\u002Forthopedic comorbidities that preclude stationary cycling or walking\n5. Significant cardiac\u002Frenal\u002Fhepatic\u002Fhematological\u002Fpulmonary disease precluding exercise training\n6. Unstable angina or myocardial infarction within 4-weeks prior to treatment\n7. Complex ventricular arrhythmias or New York Heart Association class IV symptoms\n8. Symptomatic severe aortic stenosis\n9. Acute pulmonary embolus\n10. Acute myocarditis\n11. Untreated high-risk proliferative retinopathy\n12. Recent retinal hemorrhage\n13. Uncontrolled hypertension (systolic blood pressure \\> 180 mm Hg or diastolic blood pressure \\> 120 mm Hg)\n14. Severe baseline electrolyte abnormalities (e.g. potassium) that may predispose patient to arrhythmias in the opinion of the treating investigator\n15. Uncontrolled metabolic disease (diabetes with fasting blood sugar \\>300 mg\u002Fdl, thyrotoxicosis, myxedema)\n16. Symptomatic peripheral vascular disease\n17. Prior treatment with taxane- or platinum- based chemotherapy\n18. Prior treatment with PARP \\[Poly (ADP-ribose) polymerase\\] inhibitors\n19. Prior treatment with radium-223 or lutetium-177",{"count":92,"type":20},24,[94],"NA","This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)\u002FARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.",[26,97],"Metastatic Prostate Cancer",[99,100,101,32,102,103,104],"prostate","metastatic prostate cancer","metastatic castrate-sensitive prostate cancer","exercise","ADT","ARSI","2026-04-27",{"date":107,"type":39},"2026-05-04",{"date":109,"type":39},"2024-07-26",{"date":111,"type":20},"2027-11",{"name":113,"class":46},"Paul Viscuse",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":47},"100566240","psa-biochemical-response-as-prognostic-factor-in-metastatic-castration-sensitive-prostate-cancer-100566240","NCT06652607","PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer","Evaluation of Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer and Analysis of Baseline Characteristics Between Patients With or Without PSA Value of 0.2 ng\u002Fdl.","PSA-DEEP02","Inclusion Criteria:\n\n* Aged ≥ 18 years old;\n* Men with histologically or cytologically confirmed adenocarcinoma of the prostate with evidence of metastases;\n* ECOG performance status ≤2;\n* Staging of disease with TC + bone scintigraphy or with PET PSMA\u002Fcholine;\n* Availability of baseline PSA and after six months (±1) from the beginning of the ADT;\n* Ongoing or completed treatment with at least one ARPI among abiraterone acetate, apalutamide, darolutamide and enzalutamide;\n* Adequate information about baseline demographic, biological, clinical and laboratory data;\n* Signed informed consent form, or declaration in lieu of informed consent form, if applicable.\n\nExclusion Criteria:\n\n* Patients without evidence of histological diagnosis of prostate cancer;\n* No follow up visit after the beginning of therapy;\n* No availability of baseline informations.",{"count":123,"type":20},152,"OBSERVATIONAL","Prostate cancer remains the most common malignancy in men in Europe. Over the last two decades, the treatment landscape for both localized and metastatic prostate cancer has been revolutionized. For patients with metastatic castration-sensitive prostate cancer (mCSPC), the primary treatment objectives are to delay progression to metastatic castration-resistant prostate cancer (mCRPC) and to improve overall survival (OS). Although patients with PC may initially respond to androgen deprivation therapy (ADT), progression to castration resistance occurs in 10-20% of patients within 5 years.\n\nPrimary ADT has been the standard of care for over 50 years. However, recent advancements have shifted treatment from ADT monotherapy for all mHSPC\u002FmCRPC patients to more intensive approaches, which include combinations of ADT with new androgen receptor pathway inhibitors (ARPIs), chemotherapy, or both, tailored to tumor characteristics such as metastatic burden.\n\nIn clinical practice, a reduction in prostatic specific antigen (PSA) levels from baseline is commonly used to monitor disease control, particularly in the castration sensitive phase (both early and metastatic). For patients with mCSPC, a decrease in PSA levels signifies that the treatment is effective. Moreover, the depth, time and duration of this PSA reduction are linked to better clinical outcomes, including OS. Although more patients achieved an optimal PSA response with intensified ADT (with ARPI or docetaxel), those with a suboptimal response have a significantly worse survival rate. Several key studies have demonstrated that achieving undetectable PSA (≤0.2 ng\u002FmL) is associated with better OS, irrespective of subgroups.\n\nThis study aims to evaluate patient survival based on PSA response and to describe baseline characteristics among patients with or without PSA response. Specifically, patients will be divided into two groups based on the achievement of PSA values ≤ 0.2 ng\u002Fdl, and overall survival (OS) and progression free survival (PFS) for each group will be evaluated. Clinical and laboratory information at baseline will be compared between the two groups. Baseline characteristics considered are histology, Gleason score, stage of disease, presence of genetic alterations, PSA values, sites and number of metastases, de novo or metachronous disease, high\u002Flow risk disease, high\u002Flow volume disease.",[27,61,26],"2025-03-11",{"date":129,"type":39},"2025-03-12",{"date":131,"type":39},"2024-12-20",{"date":133,"type":20},"2028-04-30",{"name":135,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]