[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-sensitive-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-sensitive-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,60,88,119,144],{"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":30,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100595161","phase-3-this-study-will-explore-whether-a-combination-of-the-investigational-drug-mevrometostat-pf-06821497-and-enzalutamide-will-work-better-than-taking-enzalutamide-alone-in-participants-with-mcspc-who-are-arpi-nave-100595161",false,"NCT07028853","This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)","Inclusion Criteria\n\n* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.\n* Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue\u002Fvisceral disease).\n* Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).\n* Participants must have ECOG PS 0 or 1.\n\nExclusion Criteria\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Clinically significant cardiovascular disease.\n* Known or suspected brain metastasis or active leptomeningeal disease.\n* Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.\n* Previous administration with an investigational product (drug or vaccine) within 30 days.\n* Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.\n* Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization\n* Current use or anticipated need for drugs that are known strong CYP3A4\u002F5 inhibitors and inducers (with exception of enzalutamide as part of this study).\n* Inadequate organ function.\n* Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.","MALE","18 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.",[26,27,28,29],"Metastatic Castration Sensitive Prostate Cancer (mCSPC)","Hormone Sensitive Prostate Cancer","Prostate Cancer","Cancer of the Prostate",[27,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Mevrometostat","Metastatic castration sensitive prostate cancer","PF-06821497","EZH2","enhancer of zeste homologue-2","enzalutamide","mCSPC","HSPC","Prostate cancer","castrate sensitive prostate cancer","prostatecancer-study.com","Phase 3","efficacy","safety","pharmacokinetics","pharmacodynamics","RECRUITING","2026-06-26",{"date":50,"type":51},"2026-06-30","ACTUAL",{"date":53,"type":51},"2025-09-28",{"date":55,"type":20},"2034-12-08",{"name":57,"class":58},"Pfizer","INDUSTRY",341,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100546235","phase-2-psma-directed-para-aortic-radiation-therapy-for-oligorecurrent-prostate-cancer-100546235","NCT06392295","PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer","A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial","OCEAN","Inclusion Criteria:\n\n1. Histologically proven prostate adenocarcinoma\n2. Male, ≥ 18 years old\n3. Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes\n\n   * a. No more than a total of 5 lesions on PSMA PET\u002FCT scan (each lesion defined as positive with standardized uptake value (SUV) \\> liver uptake and CT scan correlate)\n   * b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes\n   * c. At least one lesion in the sub-diaphragmatic pelvic or para-aortic lymph nodes\n   * d. Non-bulky nodal disease (ie, tumor \\\u003C5 cm)\n4. Prior pelvic radiation with disease response\n\n   * a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and\u002For\n   * b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes\n5. Hormone-sensitive prostate cancer\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n7. Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s)\n8. Willingness to fill out quality of life and psychosocial forms\n9. Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)\n\nExclusion Criteria:\n\n1. No pathological diagnosis of prostate adenocarcinoma\n2. Patient has more than 5 sites of metastatic disease\n3. Patient has history of bone and\u002For visceral metastasis\n4. No evidence of disease in the para-aortic or pelvic lymph nodes\n5. No staging with PSMA PET\u002FCT scan\n6. History of prior radiation therapy outside the pelvis for prostate cancer\n7. Bulky nodal disease \\>5 cm in tumor size\n8. Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET\u002FCT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment\n9. Suspicious radiologic evidence of disease in the prostate on staging PSMA PET\u002FCT scan without confirmatory negative prostate biopsy\n10. Implanted hardware which limits treatment planning or delivery (determined by treating physician)\n11. Castration-resistant prostate cancer (history of rising PSA with serum testosterone level \\\u003C50 ng\u002FdL)\n12. Patients with ECOG performance status \\> 2\n13. History of inflammatory bowel disease\n14. History of malignancy other than prostate cancer except for non-melanoma skin cancer\n15. Patients unable to consent or are prisoners\n16. Unwilling to fill out quality of life and psychosocial forms\n17. Participants with impaired decision-making capacity",{"count":69,"type":20},34,[71],"PHASE2","The purpose of this prostate cancer research study is to learn about:\n\n1. Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;\n2. Preserving quality of life after radiation therapy;\n3. Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)\u002Fcomputed tomography (CT) scans to evaluate and manage disease progression.",[28,74,27],"Prostate Adenocarcinoma",[76],"Oligorecurrent Disease","2026-06-12",{"date":79,"type":51},"2026-06-16",{"date":81,"type":51},"2024-07-03",{"date":83,"type":20},"2029-08-01",{"name":85,"class":86},"University of Miami","OTHER",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":106,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":87},"100466318","phase-3-metastasis-directed-therapy-for-oligorecurrent-prostate-cancer-100466318","NCT05352178","Metastasis-directed Therapy for Oligorecurrent Prostate Cancer","a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?","SPARKLE","Inclusion Criteria:\n\n* Histologically proven initial diagnosis of prostate adenocarcinoma\n* Priory treated and controlled primary tumor\n* Biochemical recurrence defined by prostate-specific antigen (PSA) values \\>0,2 ng\u002Fml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng\u002Fml above the nadir after high-dose RT.\n* Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5.\n* Serum testosterone level within normal range.\n* WHO performance 0-2\n* Age \\>= 18 years old\n* Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol.\n* Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board.\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* 2\\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n\nExclusion Criteria:\n\n* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n* Serum testosterone level at castration level.\n* PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)\n* Presence of poly-metastatic disease, defined as more than 5 metastatic lesions.\n* Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.\n* Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.\n* Contra indications for intake of enzalutamide (seizure or any condition that may predispose to seizure; significant cardiovascular disease within the last three months including myocardial infarction, unstable angina, congestive heart failure, ongoing arrythmias of grade \\> 2 or a thromboembolic event).\n* Not able to understand the treatment protocol or sign informed consent.",{"count":97,"type":20},873,[23],"The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and\u002For metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.",[28,101,102,103,104,105,27],"Prostate Cancer Recurrent","Prostate Cancer Metastatic","Metastatic Cancer","Oligometastatic Disease","Oligometastasis",[107,108,109,110],"Androgen deprivation therapy","Androgen receptor targeted agent","Stereotactic body radiation therapy","Metastasis-directed therapy","2024-07-01",{"date":81,"type":51},{"date":114,"type":51},"2022-04-20",{"date":116,"type":20},"2032-04-25",{"name":118,"class":86},"Universitaire Ziekenhuizen KU Leuven",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":127,"targetDuration":129,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100552451","evaluation-of-clinical-outcomes-of-chemotherapy-or-androgen-receptor-targeting-agent-alone-or-combined-or-radiotherapy-on-primary-tumor-in-addition-to-androgen-deprivation-therapy-in-hormone-sensitive-metastatic-prostate-cancer-patients-100552451","NCT06473259","Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients","Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Therapy (Alone or in Combination) or Radiotherapy on the Primary Tumor in Combination With Androgen Deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer: Multicenter Observational Study of Patients Undergoing Treatment in Clinical Practice in Italian Hospitals","ECHOS","Inclusion Criteria:\n\n1. histologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic, not undergoing previous treatment (except hormone therapy initiated no more than 4-6 months prior to docetaxel) for metastatic disease\n2. treatment with docetaxel, ARPI (alone or in combination) or with radiation therapy on the primary tumor in combination with ADT within normal clinical practice or expanded access programs initiated between January 2015 and December 2027.\n3. availability of inpatient and\u002For outpatient medical records for clinical data collection\n\nExclusion Criteria:\n\n1. histological diagnosis other than adenocarcinoma\n2. patients who have received multiple lines of ADT for mCSPC\n3. patients who have received docetaxel or ARTA for metastatic castration-resistant disease",{"count":128,"type":20},3000,"5 Years","OBSERVATIONAL","The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice",[28,27,133],"Metastatic Tumor","2024-06-24",{"date":136,"type":51},"2024-06-25",{"date":138,"type":51},"2016-12-16",{"date":140,"type":20},"2028-12",{"name":142,"class":86},"Santa Chiara Hospital",3,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":87},"100514844","phase-3-comparing-the-efficacy-and-safety-of-rezvilutamideadtdocetaxel-versus-rezvilutamide-adt-in-the-mhspc-100514844","NCT05983783","Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC","A Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Inclusion Criteria:\n\n1. Males aged ≥40 years and ≤80 years.\n2. Histologically or cytologically confirmed prostate adenocarcinoma.\n3. Metastatic disease.\n4. Eligible for ADT and Docetaxel.\n5. Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.\n6. ECOG score of 0 or 1.\n7. Laboratory tests meet the following requirements:\n\n   * Hematology: neutrophils ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, hemoglobin ≥9g\u002FdL.\n   * Renal function: serum creatinine ≤1.5× upper limit of normal (ULN).\n   * Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN.\n   * Coagulation function: international normalized ratio (INR) \\\u003C1.5.\n8. Study subjects: Patients with mHSPC have a confirmed pathology of prostate adenocarcinoma with high tumor burden, which is defined by having at least one of the following conditions:\n\n1\\) Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine).\n\n2\\) CT\u002FMRI revealing visceral metastatic lesions (excluding lymph nodes).\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria are not eligible to participate in this study:\n\n1. Prior use of LHRH agonists\u002Fantagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.\n2. Received radiation therapy\u002Fradiopharmaceutical treatment within 2 weeks before randomization.\n3. Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe\u002Funstable angina pectoris, coronary artery\u002Fperipheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV).\n4. Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization.\n5. Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.\n6. Inability to take oral medication.","40 Years","80 Years",{"count":154,"type":20},200,[23],"Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.",[158,27,159],"Metastatic Prostate Cancer","Chemotherapy Effect",[161,162,163,107],"Rezvilutamide","mHPSC","chemotherapy","2023-08-02",{"date":166,"type":51},"2023-08-09",{"date":168,"type":51},"2023-08-01",{"date":170,"type":20},"2027-12-31",{"name":172,"class":86},"The First Affiliated Hospital with Nanjing Medical University"]