[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urogenital-diseases-male\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urogenital-diseases-male":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"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":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100530754","phase-1-gedatolisib-in-combination-with-darolutamide-in-metastatic-castration-resistant-prostate-cancer-100530754",false,"NCT06190899","Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer","A Phase 1\u002F2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria\n\n1. Adult males ≥18 years of age\n2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \\\u003C10% neuroendocrine type cells\n3. Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy)\n4. Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy. Measurable and non-measurable disease are allowed, but metastases visible only on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) will not be allowed for eligibility purposes.\n5. Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one of the following criteria:\n\n   5.1. Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. A minimum PSA of 1.0 ng\u002FmL is required for study entry.\n\n   5.2. Soft-tissue progression defined as an increase ≥20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 5.3. Progression of bone disease (measurable disease) or 2 or more new bone lesions by bone scan.\n6. Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy\n7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1\n8. Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)\n9. Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug\n10. At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and\u002For radiation therapy, and resolution of all toxicities related to prior therapies or surgical procedures to baseline (except alopecia, Grade 1 peripheral neuropathy)\n11. Adequate bone marrow, hepatic, renal and coagulation function\n\nExclusion Criteria\n\n1. History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥3 years\n2. Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells\n3. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor\n4. Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide).\n5. Subjects with uncontrolled type 1 or type 2 diabetes\n\n9\\. Known and untreated, or active, brain or leptomeningeal metastases. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to randomization 10. History of clinically significant cardiovascular abnormalities 11. Gastrointestinal tract disease resulting in an inability to absorb oral medication as well as history of inflammatory bowel disease 12. Unable to swallow oral medication tablets\u002Fcapsules","MALE","18 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.",[27,28,29,30,31,32],"mCRPC (Metastatic Castration-resistant Prostate Cancer)","Genital Diseases, Male","Urogenital Diseases, Male","Prostatic Disease","Prostatic Neoplasms, Castration-Resistant","Prostate Cancer",[34,35,36,37,38,32,31,30,29,28],"Gedatolisib","PI3K","Protein Kinase Inhibitors","mCRPC (metastatic castration-resistant prostate cancer)","Darolutamide","RECRUITING","2026-04-07",{"date":42,"type":43},"2026-04-13","ACTUAL",{"date":45,"type":43},"2024-01-01",{"date":47,"type":20},"2030-01",{"name":49,"class":50},"Celcuity Inc","INDUSTRY",13,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":73,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100570413","phase-4-18f-fluciclovine-petct-impact-on-predicting-clinical-outcome-of-177lu-psma-617-therapy-in-patients-with-prostate-cancer-100570413","NCT06706921","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.",{"count":60,"type":20},15,[62],"PHASE4","This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.",[65,31,66,67,68,29,28,69,70,71,72],"Prostatic Neoplasms","Metastatic Prostate Cancer","Male Urogenital Diseases","Prostatic Diseases","Neoplasms","Neoplasms by Site","Urogenital Neoplasms","Genital Neoplasms, Male",[74,75,76,77,78],"Prostate cancer","PET\u002FCT","Radioligand Therapy","Metastatic Castration-Resistant Prostate Cancer","PSMA PET","2024-11-26",{"date":81,"type":43},"2024-11-27",{"date":83,"type":20},"2024-12-15",{"date":85,"type":20},"2027-11-01",{"name":87,"class":88},"VA Greater Los Angeles Healthcare System","FED",1]