RECRUITINGPhase 3INTERVENTIONAL
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
A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge
About This Trial
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.
Who May Be Eligible (Plain English)
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
BMS-986365
Specified dose on specified days
DRUG
Enzalutamide
Specified dose on specified days
DRUG
Abiraterone
Specified dose on specified days
DRUG
Docetaxel
Specified dose on specified days
DRUG
Predinsone/Prednisolone
Specified dose on specified days
Locations (20)
Central Alabama Research
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Los Angeles Cancer Network (LACN)
Anaheim, California, United States
Moores Cancer Center
La Jolla, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Local Institution - 0364
Los Angeles, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
San Francisco VA Health Care System
San Francisco, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Wichita Urology Group
Wichita, Kansas, United States
Chesapeake Urology
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
James M Stockman Cancer Institute
Frederick, Maryland, United States