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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
Locations55 sites
View on ClinicalTrials.gov →
NCT06764485
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
Interventions5
Locations55 sites
Central Alabama Research
Birmingham, Alabama, 35209
David Mooney, Site 0330205-502-4700
Local Institution - 0370
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Actively Recruiting
PhasePhase 3
SponsorCelgene
Started2025-03-13
Est. completion2027-09-12
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations55 sites
View on ClinicalTrials.gov →
NCT06764485