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BMS-986365 in Metastatic Castration-Sensitive Prostate Cancer in Patients with Suboptimal PSA Response After ADT and ARPI

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying metastatic castrate sensitive prostate cancer, a type of prostate cancer that has spread to other parts of the body but is still responding to hormone treatment. The study is testing BMS-986365, an oral capsule taken by mouth, to see whether switching from an androgen receptor pathway inhibitor to this treatment can help men whose PSA (prostate-specific antigen, a blood marker used to follow prostate cancer) has not dropped enough after about 7 months of androgen deprivation therapy and an androgen receptor pathway inhibitor.

The purpose of the study is to explore whether this treatment switch can improve the PSA response in this setting. In the study, participants first receive the standard hormone-based treatment, and then treatment is changed to BMS-986365. The study then follows how the cancer and symptoms change over time, while also checking for side effects, blood test changes, and heart tracing changes. The study also looks at general health and pain over the course of treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of the trial
You enter the trial as a person with metastatic castrate sensitive prostate cancer (mCSPC), which means prostate cancer that has spread and is still sensitive to hormone treatment.
You are in the study because your PSA response after 7 months of androgen deprivation therapy (ADT, treatment that lowers male hormones) plus androgen receptor pathway inhibition (ARPI, a medicine that blocks the hormone signal used by prostate cancer cells) is considered suboptimal.
The trial begins with a switch from ARPI treatment to BMS-986365.
Step 2
Study treatment
You take BMS-986365 by mouth as a capsule.
The dose is 600 mg each time.
You take it once daily.
The treatment continues during the study period, and the trial evaluates the effect of this switch on your PSA response.
Step 3
Response checks during treatment
Your PSA level is measured during the trial to see how the cancer responds.
The main result being checked is whether your PSA falls by 50% and stays confirmed.
Other PSA results are also checked, including a 30% response, a 90% response, and specific PSA ranges.
Step 4
Safety monitoring
Your health is monitored during treatment for side effects and other safety findings.
The trial checks for side effects, serious side effects, treatment changes caused by side effects, ecg findings, and laboratory changes.
ecg means a test that records the electrical activity of the heart.
Blood tests are used to check general laboratory values, including blood counts and blood chemistry.
Step 5
Other study assessments
The trial also measures how long it takes before the cancer gets worse, how long it takes before symptoms or bone-related problems appear, and how long it takes before another systemic treatment is started.
systemic treatment means treatment that travels through the body, such as medicine taken by mouth or given into the body.
The trial assesses overall survival.
The trial also measures changes in quality of life, daily function, and pain using study questionnaires.
The trial checks ar copy number, splice variants, and mutations at the start of the study.
ar means androgen receptor, which is the cell target used by male hormones.
The trial checks whether ctdna is present at the start of the study and how it changes during treatment.
ctdna means small pieces of tumor dna found in the blood.
Step 6
Trial period
The planned recruitment period runs from 2026-05-25 to 2029-05-25.
The trial follows participants during this study period to collect the response, safety, and outcome information listed above.

Who can join the trial?

9 criteria

Be an adult male who is at least 18 years old.
Have signed the written consent form, which means agreeing to take part in the study in writing.
Have documented metastatic castration-sensitive prostate cancer, meaning prostate cancer that has spread to other parts of the body and is still responding to hormone-lowering treatment.
Have a detectable PSA level of at least 0.2 ng/mL about 7 months after starting anti-hormone treatment, with a window of 4 weeks before or after that time.
Be currently receiving androgen deprivation therapy (ADT) and one of these androgen receptor pathway inhibitors (ARPIs), which are medicines that block male hormone signals that can help prostate cancer grow: abiraterone with prednisone or prednisolone, apalutamide, darolutamide with or without docetaxel, or enzalutamide.
Have had treatment with an ARPI for at least 4 months before joining the study.
Have an ECOG performance status of 0 or 1, which means being fully active or having only slight limits in daily activities.
Be either without symptoms or have symptoms from metastatic prostate cancer, but these must be stable. The pain score and pain medicines must also be stable, with no important change in pain medicine for at least 4 weeks before joining.
Have adequate blood count, which means enough healthy blood cells, and adequate liver and kidney function, meaning these organs are working well enough for study treatment.

Who cannot join the trial?

5 criteria

People whose prostate cancer is mainly neuroendocrine type, meaning more than 50% of the cancer cells have this pattern.
People with any liver metastasis, meaning the cancer has spread to the liver.
People with any brain metastasis, meaning the cancer has spread to the brain.
People with impaired cardiac function, meaning the heart does not work well enough, or with clinically significant cardiac disease, meaning a heart problem that is important enough to affect safety.
People whose PSA level at 7 months is below 0.2 ng/mL. PSA, or prostate-specific antigen, is a protein made by the prostate that is measured in the blood.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Goethe University Frankfurt
Verified
Frankfurt, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany
Ludwig Maximilian University Of Munich
Responsive
Munich, Germany

Trial locations

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Investigated drugs

BMS-986365 is an oral capsule used as the study treatment in this trial. It is being tested in men with metastatic castration-sensitive prostate cancer who have not had the expected drop in PSA after several months of hormone-based treatment. In this study, it is used as a switch treatment to see whether changing to BMS-986365 can improve the PSA response after prior treatment with androgen deprivation therapy and an androgen receptor pathway inhibitor.

BMS-986365

What is already known about the treatment

BMS-986365 - BMS-986365 is an oral capsule taken by mouth, and in this trial it is being studied as a treatment switch for men with metastatic castrate-sensitive prostate cancer who have not had a strong PSA response after hormone-based therapy. It is still an investigational medicine, so its full place in medical practice and the published medical literature is not yet established. Based on the trial design, it is intended for prostate cancer control, especially when current androgen-blocking treatment is not giving the expected effect, and it likely works by interfering with signals that help prostate cancer cells grow and survive. Its pharmacological class is not yet clearly defined in routine medicine because it remains under clinical study.

Investigated diseases

Metastatic Castration-Sensitive Prostate Cancer - This is prostate cancer that has spread beyond the prostate to other parts of the body but still responds to lowering testosterone. It often begins in the prostate and then gradually grows and spreads to nearby tissues, lymph nodes, bones, or other organs. At this stage, the cancer is still sensitive to hormone changes, so its behavior is strongly influenced by male hormone levels. Over time, some cancer cells may become less responsive to hormone control and the disease can progress further.