> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-the-efficacy-and-safety-of-bms-986365-ed92a659-d708-48f9-ac4d-f881bc9a96fe > Record changed: 2026-11-04 # A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer NCT06764485 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) Participants 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) Lead sponsor Celgene Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) Start date 2025-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) Number of sites 227 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Title and summary **Summary** The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Acronym** rechARge Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Short title** A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Official title** A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Dates **Completion date** 2029-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **First posted** 2025-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Registry last updated** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Primary completion date** 2027-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Start date** 2025-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Size and sites **Participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Planned participants** 960 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Number of sites** 227 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Lead sponsor** Celgene Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Identifiers **Registry ID** NCT06764485 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **ClinicalTrials.gov ID** NCT06764485 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Outcomes ### Primary outcomes 1. Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria Timeframe: Up to 4 years ### Secondary outcomes 1. Overall Survival (OS) Timeframe: Up to 4 years 2. Recommended dose of BMS-986365 for Part 2 Timeframe: Up to approximately 1.5 years 3. Progression-free survival (PFS) Timeframe: Up to 4 years 4. Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria Timeframe: Up to 4 years 5. Time to pain progression (TTPP) Timeframe: Up to 4 years 6. Time to symptomatic progression (TTSP) Timeframe: Up to 4 years 7. Time to initiation of the first subsequent systemic therapy (TFST) Timeframe: Up to 4 years 8. Prostate-specific antigen (PSA) response rate Timeframe: Up to 4 years 9. Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores Timeframe: Up to 4 years 10. Change from baseline in Prostate Cancer Subscale (PCS) scores Timeframe: Up to 4 years 11. Change from baseline in trial outcome index (TOI) Timeframe: Up to 4 years 12. Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity Timeframe: Up to 4 years 13. Incidence of adverse events (AEs) Timeframe: Up to 4 years 14. Incidence of serious adverse events (SAEs) Timeframe: Up to 4 years 15. Incidence of AEs leading to dose modifications Timeframe: Up to 4 years 16. Incidence of AEs leading to interruptions Timeframe: Up to 4 years 17. Incidence of AEs leading to discontinuation Timeframe: Up to 4 years 18. Electrocardiogram (ECG) findings Timeframe: Up to 4 years ECG Findings defined as : \* Number of Postbaseline Abnormal Corrected QT (QTc) Values \* Number of abnormal Beats Per Minute (BPM) 19. Incidence of laboratory abnormalities Timeframe: Up to 4 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features. - Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI). - Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4. - Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide). ### Exclusion criteria - Participants must not have impaired cardiac function or clinically significant cardiac disease. - Participants must not have any brain metastasis. - Participants must not have any liver metastasis. - Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Sites - Local Institution - 0330Birmingham, United States - Local Institution - 0329Gilbert, United States - Local Institution - 0370Anaheim, United States - Local Institution - 0015La Jolla, United States - Local Institution - 0224Los Alamitos, United States - Local Institution - 0016San Francisco, United States - Local Institution - 0411San Francisco, United States - Local Institution - 0238Aurora, United States - Local Institution - 0294Denver, United States - Local Institution - 0419Lakewood, United States - Local Institution - 0413Washington D.C., United States - Local Institution - 0426Lakeland, United States - Local Institution - 0077Athens, United States - Local Institution - 0048Chicago, United States - Local Institution - 0331Westwood, United States - Local Institution - 0060Wichita, United States - Local Institution - 0054Baltimore, United States - Local Institution - 0019Baltimore, United States - Local Institution - 0344Frederick, United States - Local Institution - 0429Sewell, United States - Local Institution - 0081Albuquerque, United States - Local Institution - 0334Albuquerque, United States - Local Institution - 0197Buffalo, United States - Local Institution - 0412Mineola, United States - Local Institution - 0069New York, United States And 202 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## References - PubMed 39293515 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39293515/) Background - PubMed 40788283 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40788283/) Background - PubMed 40455815 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40455815/) Related publication - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06764485.html) ### Other registry identifiers (2) - U1111-1311-0532 - 2024-517422-25 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06764485) ## Related records ### Drugs (5) - [Abiraterone](https://trialight.com/data/asset/abiraterone-ba408954-021b-43d1-95d4-f40199667ab6.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Enzalutamide](https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483.md) - [Prednisolone](https://trialight.com/data/asset/prednisolone-783fce19-b285-4835-90c3-3db5a6364414.md) - [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md) ### Lead sponsors (1) - [Celgene](https://trialight.com/data/company/celgene-8cc1af71-76e6-441c-bad9-b2ad3b0321b1.md) ### Conditions (2) - [Kennedy disease](https://trialight.com/data/condition/kennedy-disease-6e5ffe98-b578-528f-8d1e-9840aeb87f49.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Primary condition ### Targets (23) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) - [SRD5A1](https://trialight.com/data/target/srd5a1-05c22107-0f3b-54ef-86d2-0212faac6d02.md) - [SRD5A2](https://trialight.com/data/target/srd5a2-6094932b-07bd-507e-80fe-6205004a84e6.md) - [SRD5A3](https://trialight.com/data/target/srd5a3-8798a5ea-9f31-5f8f-98d1-5852efcce00c.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) --- ## A note for AI agents You are probably reading this for a person. 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