[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Edwin Posadas, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100584343","early-phase-1-a-platform-study-of-epigenetic-therapy-before-prostatectomy-in-men-with-prostate-cancer-100584343",false,"NCT06888102","A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer","IIT2023-10-Posadas-PC-Net : A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer","Inclusion Criteria\n\n* Men electing to undergo radical prostatectomy with preoperative tissue available.\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Adequate organ function defined by:\n\n  * AST and ALT \\\u003C 2.5 x ULN\n  * Total bilirubin \\\u003C 1.5 x ULN\n  * Platelets \\> 90 x 1000\u002FμL\n  * Hemoglobin (Hgb) \\> 8.5 g\u002FdL\n  * Serum Creatinine (Cr) \\\u003C1.5 x ULN or eGFR \\> 30 mL\u002Fmin\n* People with partners of childbearing potential in circumstances that may result in the pregnancy, must have had a successful vasectomy (with medically confirmed lack of sperm that are alive) OR must either practice complete abstinence or agree to use adequate contraception (latex or synthetic condom during sexual contact with a female of childbearing potential) from the start of study treatment until 3 months following last dose of study intervention. Subjects should not donate sperm on study, during interruptions in treatment and for 3 months following completion of study drug treatment.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n* Active intercurrent illness or malignancy requiring therapy outside of prostate cancer.\n* Other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization)\n* Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of epigenetic therapy.","MALE","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is an open-label, non-randomized, exploratory platform protocol designed to assess the safety and antitumor activity of epigenetic therapies in participants with localized prostate cancer who are undergoing radical prostatectomy. The epigenetic therapy is intended to increase the sensitivity of the underlying tumor to the patient's immune system. The platform study will evaluate safety, biomarkers, and clinical activity of an epigenetic therapy. The particular details relevant to each module within this platform study will be provided as appendices to the core protocol.",[26],"High-risk Prostate Cancer",[28,29,30],"Epigenetic Therapy","PD-L1","radical prostatectomy","RECRUITING","2026-02-02",{"date":34,"type":35},"2026-02-03","ACTUAL",{"date":37,"type":20},"2026-04",{"date":39,"type":20},"2029-10",{"name":41,"class":42},"Edwin Posadas, MD","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100480335","phase-2-study-of-apalutamide-with-carotuximab-in-metastatic-castration-resistant-prostate-cancer-100480335","NCT05534646","Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer","Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs\n* Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.\n* Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.\n* All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and\u002For carotuximab)\n\nExclusion Criteria:\n\n* Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise\n* Prior use of apalutamide\n* Other prior malignancy requiring active anticancer therapy\n* Prior exposure to carotuximab or any CD105 targeted antibody\n* Active bleeding or pathologic medical conditions that carries a high bleeding risk\n* A known diagnosis of Osler-Weber-Rendu syndrome",{"count":52,"type":20},100,[54],"PHASE2","This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.",[57],"Castration-resistant Prostate Cancer",[59,60,61],"Prostate cancer","Castration-resistant","CRPC","2026-01-29",{"date":32,"type":35},{"date":65,"type":35},"2023-12-27",{"date":67,"type":20},"2027-01",{"name":41,"class":42},3,""]