At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BMS-986365 (drug), Enzalutamide (drug), Abiraterone (drug), Docetaxel (drug)
- How long the study runs
- Study runs about 46 months (dates as stated)
- About the drug or intervention
- BMS-986365 — drug: Specified dose on specified days · Enzalutamide — drug: Specified dose on specified days · Abiraterone — drug: Specified dose on specified days · Docetaxel — drug: Specified dose on specified days · Predinsone/Prednisolone — drug: Specified dose on specified days
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 960
- Started
- 2025-03-13
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic castration-resistant prostate cancer
- • Phase3 - 960 participants
- • 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 can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic castration-resistant prostate cancer
- • Male only
Where?
- • Glasgow - Local Institution - 0393
- • Northwood - Local Institution - 0383
- • London - Local Institution - 0266
- • London - Local Institution - 0391
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of BMS-986365 versus investigator's choice comprising Docetaxel + Prednisone/Prednisolone or Abiraterone + Prednisone/Prednisolone or Enzalutamide. In Part 1, participants will be randomized 1:1:1 to one of the two BMS-986365 dose levels, or to the active comparator arm (investigator's choice). In Part 2 of the study, participants will be randomized 1:1 between BMS-986365 selected dose, or to the active comparator arm (investigator's choice).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
What the study is looking for
- ✓Inclusion Criteria
- ✓Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or...
- ✓Participants must be not causing symptoms or mildly causing symptoms from prostate cancer with score on Brief Pain Inventory -...
- ✓Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone,...
- ✓Exclusion Criteria
See the full criteria
Where Is This Study? (5 UK sites)
Local Institution - 0393
Glasgow G12 0YN, United Kingdom
Local Institution - 0383
Northwood HA6 2RN, United Kingdom
Local Institution - 0266
London EC1A 7BE, United Kingdom
Local Institution - 0391
London SM2 5PT, United Kingdom
Local Institution - 0248
Manchester M20 4BX, United Kingdom