A Phase 1/2 Study of EPI-7386 in Combination with Enzalutamide Compared with Enzalutamide Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer
This research study is investigating a new medication called EPI-7386 when given alongside Xtandi, an established prostate cancer drug. It's specifically for men whose prostate cancer has spread to other parts of the body and is no longer controlled by standard hormone treatments (this is called metastatic castration-resistant prostate cancer). The first part of the study (Phase 1) will check the safety of the new drug combination and help find the right dose. The second part (Phase 2) will then look at how well the combination treatment works, for example, by seeing how much it lowers levels of a protein called PSA, which can be a sign of prostate cancer activity. The goal is to find better ways to treat this type of advanced prostate cancer.
At a glance
What is this study about?
This study is trying to find better ways to treat a type of advanced prostate cancer called metastatic castration-resistant prostate cancer. This means the cancer has spread beyond the prostate gland to other parts of the body, and it's no longer being controlled by standard hormone-blocking treatments.
The study is testing a new drug called EPI-7386. Researchers want to see if combining EPI-7386 with an existing prostate cancer drug called Xtandi (the active ingredient is enzalutamide) can be more effective than Xtandi alone. Xtandi is already approved and used to treat prostate cancer.
This is a 'Phase 1/2' study. Phase 1 is about making sure the new drug combination is safe and finding the best dose. Doctors will carefully watch for any side effects. Once a safe dose is found, Phase 2 will then look at how well the treatment works to shrink or control the cancer, for instance, by checking changes in blood tests like PSA levels. The overall aim is to improve treatment options for men with this challenging form of prostate cancer.
Key takeaways
- The study tests a new drug (EPI-7386) with an existing one (Xtandi) for advanced prostate cancer.
- It's for men whose prostate cancer has spread and isn't responding to hormone therapy.
- The first part of the study focuses on safety, the second on how well it works.
- You will have regular check-ups, tests, and medical monitoring if you take part.
- Participation is voluntary, and you can withdraw at any time.
- Understanding the potential benefits and risks is important before you decide to join.
Who may be eligible?
This study is particularly for men who have advanced prostate cancer that has spread to other parts of their body and is not responding to current hormone treatments. You must be at least 18 years old to take part. There is no upper age limit, meaning older men can also be considered.
There will be specific health checks and tests to make sure that the treatment is suitable and safe for you. For example, doctors will need to check your general health, organ function, and current cancer status to ensure you meet all the requirements for joining the study.
It's important to understand that not everyone with this type of prostate cancer will be able to join the study. The medical team will carefully review your health history and test results to see if you are a good fit and if it's safe for you to participate.
- Are you a man?
- Are you at least 18 years old?
- Do you have prostate cancer that has spread to other parts of your body?
- Is your prostate cancer no longer responding to hormone-blocking treatments?
- Are you able to take medicines by mouth (capsules)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll be given either the new drug EPI-7386 alongside Xtandi, or Xtandi on its own. You'll take these medications as capsules. Throughout the study, you'll have regular hospital visits to see the study doctors and nurses. These visits will involve various assessments, such as blood tests (to check how the treatment affects your body and cancer), urine tests, physical examinations, and possibly scans to monitor your cancer. You'll also have regular checks of your heart (ECGs) and vital signs (like blood pressure).
During the first stage of the study, visits might be more frequent as doctors carefully monitor for any side effects and work out the right dose. Later stages will involve regular follow-up visits to see how well the treatment is working. The exact length of your participation will depend on how you respond to the treatment, but you would be fully informed of the expected duration. You can stop participating in the study at any time.
Potential risks and benefits
Locations (3)
- —Spain
- —Belgium
- —France
Common questions
What is 'castration-resistant prostate cancer'?
This means your prostate cancer is no longer responding to treatments that lower male hormones, even though those treatments are still being given.
What is 'metastatic' prostate cancer?
This means the cancer has spread from the prostate gland to other parts of your body, like your bones or lymph nodes.
What is EPI-7386?
EPI-7386 is a new drug being tested in this study. It's designed to work against prostate cancer.
What is Xtandi?
Xtandi is an established medicine (also known by its active drug name enzalutamide) that is already used to treat advanced prostate cancer.
Will I definitely get the new drug?
This study compares the new drug plus Xtandi against Xtandi alone. The study team will explain how it's decided which treatment you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.