A Study to Compare BMS-986365 Versus Investigator's Choice Therapy for Advanced Prostate Cancer
Phase 3
960
about 3.9 years
18+
Male only
53 sites in AL, AZ, CA +22
What this study is about
Researchers are testing whether BMS-986365, a treatment, is more effective and safer than the standard treatment chosen by doctors for men with advanced prostate cancer that has returned after initial treatment. The trial will last about 1408 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Abiraterone
- 2.Take BMS-986365
- 3.Take Docetaxel
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
abiraterone, docetaxel, enzalutamide, prednisolone
infusion, oral (Oral Tablet), oral (Disintegrating Oral Tablet)
Primary: Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Secondary: Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity, Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores, Change from baseline in Prostate Cancer Subscale (PCS) scores, Change from baseline in trial outcome index (TOI), Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria, Incidence of AEs leading to discontinuation, Incidence of AEs leading to dose modifications, Incidence of AEs leading to interruptions
Oncology