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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

RECRUITINGPhase 3Sponsored by Celgene
Actively Recruiting
PhasePhase 3
SponsorCelgene
Started2025-03-13
Est. completion2027-09-12
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations53 sites

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions2

CancerMetastatic Castration-resistant Prostate Cancer

Locations53 sites

Central Alabama Research
Birmingham, Alabama, 35209
David Mooney, Site 0330205-502-4700
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Isaac Bowman, Site 0329480-256-6444
Los Angeles Cancer Network (LACN)
Anaheim, California, 92801
Ronald Tang, Site 0370626-288-0008
Moores Cancer Center
La Jolla, California, 92093
Rana McKay, Site 0015
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Vu Phan, Site 0224562-735-0602

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