A Phase 3 Study Comparing BMS-986365 versus Investigator's Choice of Therapy in Participants with Metastatic Castration-resistant Prostate Cancer

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250827

Enrollment

960

Registered

2026-03-23

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

Part 1:BMS-986365 will be administered at two dose levels according to the specified dosing regimen, or abiraterone plus prednisolone, enzalutamide, or docetaxel plus prednisolone will be administered

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Radiographic progression-free survival (rPFS)	—

Secondary

Measure	Time frame
Overall Survival (OS)	—

Countries

Argentina, Australia, Austria, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Germany, India, Ireland, Italy, Japan, Poland, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactAntoine Vuillemin

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 30, 2026