At a glance

ClinicalIndex Comparison Record

Phase 3Recruiting· 960 target

Drug / intervention

BMS-986365 +4 moredrug

Likely dose

Not stated in record

Key inclusion· 4

✓Histologic or cytologic confirmation of prostate adenocarcinoma without small cell or neuro-endocrine features
✓Current evidence of metastatic disease on bone scan and/or CT/MRI
✓Asymptomatic or mildly symptomatic with BPI-SF score <4
✓Prior treatment with androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide)

Key exclusion· 4

✕Impaired cardiac function or clinically significant cardiac disease
✕Any brain metastasis
✕Any liver metastasis
✕Superscan on technetium-99m radionuclide bone scan

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06764485

NCT06764485Phase 3RecruitingHigh Momentum

Compare CT.gov

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

Celgene·interventional·Posted Jan 8, 2025·Updated Jun 26, 2026

In Brief

A Phase 3 clinical trial evaluating BMS-986365, Enzalutamide, and 3 other interventions for Metastatic Castration-resistant Prostate Cancer. Currently recruiting, targeting 960 participants across 282 sites in 26 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMetastatic Castration-resistant Prostate Cancer

CountriesArgentina, Australia, Austria, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, India, Ireland, Italy, Japan, Poland, Puerto Rico, Romania, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States

Collaborators--

Timeline

Phase 3Recruiting

20252026202720282029

First PostedJan 2025

Enrollment StartMar 2025

TodayJul 2026

Primary CompletionSep 2027

Study CompletionJan 2029

First PostedJan 8, 2025

Enrollment StartMar 13, 2025

Primary CompletionSep 12, 2027

Study CompletionJan 19, 2029

TodayJul 2, 2026

Enrollment to primary: 2.5 yearsPosted 1.5 years agoPrimary completion in 1.2 years

Arms & Interventions

Part 1: Dose 1experimental

Drug: BMS-986365

Part 1: Dose 2experimental

Drug: BMS-986365

Part 1: Comparator 1active_comparator

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Drug: EnzalutamideDrug: AbirateroneDrug: Predinsone/Prednisolone

Part 1: Comparator 2active_comparator

Drug: DocetaxelDrug: Predinsone/Prednisolone

Part 2: Dose Selectedexperimental

Drug: BMS-986365

Part 2: Comparator 1active_comparator

Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Drug: EnzalutamideDrug: AbirateroneDrug: Predinsone/Prednisolone

Part 2: Comparator 2active_comparator

Drug: DocetaxelDrug: Predinsone/Prednisolone