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NCT06764485
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
Conditions: Metastatic Castration-resistant Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 960
Sponsor: Celgene
Location: Local Institution - 0330 Birmingham Alabama
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 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
* 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.
Source: ClinicalTrials.gov (NCT06764485). StuddyBuddy aggregates publicly available trial information.