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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

NCT06764485

RecruitingPhase 3

Sponsor: Celgene

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone

Countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (281)

Birmingham, Alabama, United States
Gilbert, Arizona, United States
Anaheim, California, United States
La Jolla, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
San Francisco, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Washington D.C., District of Columbia, United States
Lakeland, Florida, United States
Athens, Georgia, United States
Chicago, Illinois, United States
Westwood, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
Minneapolis, Minnesota, United States
Las Vegas, Nevada, United States
Sewell, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
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