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

Official record

Identifier

NCT06764485

Recruiting locations

countries

United StatesArgentinaAustraliaAustriaBrazilCanadaChileChinaCzechiaDenmarkFinlandFranceGermanyIrelandIsraelItalyMexicoPolandPuerto RicoRomaniaSlovakiaSouth KoreaSpainSwedenTaiwanUnited Kingdom

Interventions studied

BMS-986365EnzalutamideAbirateroneDocetaxelPredinsone/Prednisolone

Lead sponsor

Celgene

Target enrolment

960 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Jan 8, 2025

Last updated on the registry

Sep 30, 2026

Age

18 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Prostate Cancer