RecruitingPHASE3INTERVENTIONAL

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

This study is investigating a new medication called BMS-986365 for men who have prostate cancer that has spread to other parts of the body (metastatic) and is no longer being controlled by hormone therapy (castration-resistant). The main goal is to compare how well BMS-986365 works and its safety against treatments that doctors usually choose, such as enzalutamide, abiraterone, or docetaxel (often given with prednisolone). This research will help us understand if BMS-986365 could be a helpful new treatment option for this type of prostate cancer. It's a Phase 3 study, which means it's testing the new drug on a larger group of people to confirm its effectiveness and safety.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Celgene

Enrolment target

960

Start

13 Mar 2025

Estimated completion

19 Jan 2029

Metastatic Castration-resistant Prostate Cancer

What is this study about?

This research study is looking into a new medication called BMS-986365. It's designed for men with advanced prostate cancer that has spread to other parts of the body, also known as metastatic prostate cancer. This is specifically for cancer that has become 'castration-resistant,' meaning it's no longer responding to standard hormone-blocking treatments.

The main purpose of this study is to compare the new drug, BMS-986365, with standard treatments that doctors often use for this type of prostate cancer. These standard treatments might include medications like enzalutamide, abiraterone, or docetaxel (which is usually given with another drug called prednisolone). By comparing the new drug to these established treatments, researchers want to find out if BMS-986365 is more effective at slowing down the cancer's growth and spread, and if it's safe for patients to take.

This is a Phase 3 study, which means the new medication has already undergone earlier testing and shown promise. Now, it's being tested on a larger group of people to confirm its benefits and side effects. Ultimately, the goal is to see if BMS-986365 could become a new, valuable treatment option to help men with this type of prostate cancer live longer and with a better quality of life.

Key takeaways

This study evaluates a new drug, BMS-986365, for advanced prostate cancer.
It's for men whose prostate cancer has spread and no longer responds to hormone therapy.
The new drug is compared against existing standard treatments.
It's a large-scale study (Phase 3) to confirm safety and effectiveness.
Participation involves regular check-ups, blood tests, and scans.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be a man, aged 18 or over. You must have prostate cancer that has been confirmed by a biopsy, and it must have spread to other parts of your body, like your bones or other tissues. Your cancer should also no longer be responding to hormone treatments that lower testosterone.

It’s important that your pain from the prostate cancer is mild or absent. You also need to have tried a specific type of hormone therapy before, such as abiraterone, enzalutamide, apalutamide, or darolutamide.

There are also some reasons why you might not be able to join. For example, if you have significant heart problems, or if your cancer has spread to your brain or liver. If specialists conducting the study identify other health issues or scan results that mean it's not safe for you to take part, you may also be excluded.

Quick self-check

Are you a man aged 18 or older?
Do you have prostate cancer that has been confirmed by a biopsy?
Has your prostate cancer spread to other parts of your body?
Is your prostate cancer no longer controlled by hormone treatments?
Have you previously received a specific type of hormone therapy (e.g., abiraterone or enzalutamide)?
Do you have mild or no pain from your cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to participate in this study, you'll be assigned by chance to either receive the new drug, BMS-986365, or one of the standard treatments for prostate cancer chosen by the study doctor. You won't get to choose which treatment you receive. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, scans (like CT, MRI, and bone scans), and to make sure you're doing well and that the treatment is working as expected. These visits help us monitor your health and the effects of the medication. The study will involve a long-term follow-up to track your progress. The exact number of visits and the total duration in the study will vary depending on your individual response and the treatment plan, but the team will explain the full schedule to you.

Potential risks and benefits

Like all medical treatments, both BMS-986365 and the standard treatments have potential benefits and potential risks. The potential benefit is that the treatment might slow down your cancer's growth and spread, or improve your symptoms. However, there's no guarantee that you will personally benefit from taking part. Potential risks include side effects from the medication, which will be carefully monitored by the study team. You'll be given detailed information about all known and possible side effects. It's very important to remember that participating in the trial is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (282)

Central Alabama Research
Birmingham, United States· Recruiting
Banner MD Anderson Cancer Center
Gilbert, United States· Recruiting
Local Institution - 0370
Anaheim, United States· Completed
Moores Cancer Center
La Jolla, United States· Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, United States· Recruiting
Local Institution - 0364
Los Angeles, United States· Withdrawn
California Pacific Medical Center
San Francisco, United States· Recruiting
San Francisco VA Health Care System
San Francisco, United States· Recruiting
Local Institution - 0458
Santa Rosa, United States· Not yet recruiting
Rocky Mountain Regional VA Medical Center
Aurora, United States· Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, United States· Recruiting
Colorado Clinical Research
Lakewood, United States· Recruiting

+270 more sites — see the official record for the full list.

Common questions

What is 'castration-resistant prostate cancer'?

This means your prostate cancer is growing even though hormone treatments have lowered the levels of male hormones in your body.

What does 'metastatic' mean?

This means the cancer has spread from your prostate to other parts of your body, like your bones or other organs.

What is a 'Phase 3' study?

A Phase 3 study is a large study that compares a new treatment to existing treatments to confirm if it's safe and effective before it can be widely used.

Will I know which treatment I'm getting?

No, you will be assigned by chance (randomised) to receive either the new drug or one of the standard treatments. This helps ensure fair comparison.

What are the common standard treatments for this condition?

These often include medicines like enzalutamide, abiraterone, or docetaxel (often given with prednisolone).

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.