A phase 2 trial of BMS-986365 in mCSPC patients with suboptimal PSA-response after 7 months of Androgen Deprivation Therapy (ADT) plus Androgen Receptor Pathway Inhibition (ARPI).
This study is investigating a new medication called BMS-986365 for men in the UK who have prostate cancer that has spread to other parts of the body (metastatic prostate cancer). Specifically, it's for those whose current hormone therapy, called Androgen Deprivation Therapy (ADT) combined with another drug (ARPI), hasn't lowered their PSA levels enough after about seven months. The main goal is to see if BMS-986365 can reduce PSA levels by at least 50%. We're also checking other important things like if it stops the cancer from growing, helps with pain, and how safe it is to use. This is a "Phase II" trial, meaning we're exploring how well the drug works and checking its safety in a small group of people.
At a glance
What is this study about?
This study is all about helping men with prostate cancer that has spread to other parts of their body, known as metastatic prostate cancer. When prostate cancer spreads, it's treated with hormone therapy, specifically a combination of treatments called Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibition (ARPI). These treatments aim to reduce the male hormones that fuel prostate cancer growth.
However, for some men, even after about seven months of these treatments, their prostate specific antigen (PSA) levels — a marker doctors use to track prostate cancer — don't drop as much as hoped. This study is testing a new drug, BMS-986365, to see if it can help these men. We want to find out if this new drug can lower PSA levels significantly, which would suggest it's helping to control the cancer.
Beyond PSA levels, we'll also be looking at how the drug affects other important aspects of the patient's health. This includes whether it helps to slow down the cancer's progression, reduces pain, and improves their overall quality of life. We'll also be carefully checking for any side effects to make sure the drug is safe to use. This kind of study helps us understand if new treatments can be a good option for people when their current therapies aren't working as well as expected.
Key takeaways
- This study is for men with prostate cancer that has spread.
- It's for those whose current hormone therapy isn't fully controlling their PSA levels.
- It tests a new drug, BMS-986365, to see if it can lower PSA and slow cancer growth.
- Researchers will monitor your PSA levels, health, and quality of life.
- Participation involves regular clinic visits, blood tests, and scans.
- You can stop participating at any time.
Who may be eligible?
This study is looking for men who have prostate cancer that has spread to other parts of the body. You would need to be 18 years old or older to take part.
Crucially, your current hormone treatment for prostate cancer (a combination of ADT and ARPI) must not have lowered your PSA levels as much as doctors would hope after being on it for about seven months. Your doctors will be able to tell you if this applies to your situation.
There will be other medical checks and criteria that the study team will go through with you to make sure the study is a good and safe fit for you. These might include checking your general health and other medications you are taking.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a man with prostate cancer that has spread.
- I am 18 years old or older.
- I am currently receiving ADT and ARPI for my prostate cancer.
- My PSA levels have not dropped enough after about seven months on my current treatment.
- I am willing to attend regular clinic visits and tests.
What does participation involve?
If you decide to take part, you would receive the new study drug, BMS-986365. You would have regular visits to the hospital or clinic for check-ups. During these visits, doctors and nurses would measure your PSA levels through blood tests, and they would also keep a close eye on your general health.
You would have scans to check if the cancer is growing and to assess your pain levels and overall well-being using questionnaires. We'll also look at your blood for certain features of your cancer. The study involves taking the medication as prescribed and completing all scheduled appointments and tests. The full duration of your participation would be explained to you by the study team, including any follow-up appointments after you stop taking the study drug.
Potential risks and benefits
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Common questions
What is PSA?
PSA stands for Prostate Specific Antigen. It's a protein made by the prostate, and doctors use its level in the blood as a marker for prostate cancer activity.
What does 'metastatic' mean?
Metastatic means the cancer has spread from where it started in the prostate to other parts of the body, such as the bones.
What is 'hormone therapy' for prostate cancer?
Hormone therapy, like ADT, aims to reduce the male hormones (androgens) that can make prostate cancer grow. ARPI is another drug that helps block these hormones.
Is this drug approved already?
No, BMS-986365 is a new drug being tested in this study, which is why it's considered an experimental treatment.
What happens if the drug doesn't work for me?
The study team will monitor your progress closely. If the drug isn't working or if you have significant side effects, they will discuss other treatment options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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