Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
This research is looking at new ways to treat advanced prostate cancer that has spread and is no longer helped by standard hormone treatments (called metastatic castration-resistant prostate cancer, or mCRPC). The study is called Substudy 01A and is part of a larger research program. Its main goal is to find out how safe and effective a new investigational drug called Opevesostat is. Researchers are testing Opevesostat by itself and in combination with other existing prostate cancer drugs like Olaparib, Docetaxel, or Cabazitaxel. The study will first check for safety and find the right dose, and then look more closely at how well these treatments work. This is an early-stage study, meaning it's one of the first times these treatments are being carefully evaluated.
At a glance
What is this study about?
This study, called Substudy 01A, is designed for men with advanced prostate cancer. This is a type of prostate cancer that has spread to other parts of the body (metastatic) and has stopped responding to hormone-blocking treatments (castration-resistant). It's part of a bigger research effort to find better treatments for this condition.
The main purpose of this particular substudy is to check the safety and effectiveness of a new medicine called Opevesostat. Researchers want to see how well it works when given alone, or when combined with other drugs already used to treat prostate cancer, such as Olaparib, Docetaxel, or Cabazitaxel. They will also be using other common medicines like Fludrocortisone acetate, Dexamethasone, or Prednisone, depending on the combinations being tested.
The study has two main parts. First, there's a 'safety lead-in' phase where doctors will carefully check for any side effects and decide on the best dose of Opevesostat to use. Once a safe dose is found, the study will move into an 'efficacy phase' to see how well the treatments shrink the cancer or slow its growth. This is an important step in developing new treatments for prostate cancer.
Key takeaways
- This study is for advanced prostate cancer that has spread and resisted hormone therapy.
- It's testing a new drug called Opevesostat, alone or with other cancer medicines.
- The main goals are to check for safety and see how well the treatments work.
- You must have tried other hormone therapies for your prostate cancer already.
- Regular hospital visits, tests, and closely monitored treatment are part of your participation.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. You need to have been diagnosed with prostate cancer that has spread and is no longer responding to hormone therapy. You should have already received some form of hormone-blocking treatment or had your testicles removed.
You also need to have tried one or two newer hormone-blocking medicines for your prostate cancer, and your cancer has progressed despite these treatments. Importantly, any side effects from previous cancer treatments must have mostly gone away or returned to how you were before.
There are also some conditions that would prevent you from joining. For example, if you have poorly controlled diabetes, certain heart or brain conditions, or an uncontrolled infection like Hepatitis B or C (unless it's well managed). Your medical team will review all your health information to make sure this study is right for you.
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.
- Are you 18 years old or older?
- Do you have prostate cancer that has spread and is no longer responding to hormone treatment?
- Have you already received one or two newer hormone-blocking treatments for your prostate cancer (e.g., Abiraterone or Enzalutamide)?
- Are any side effects from your previous cancer treatments mostly gone or back to normal?
- Do you feel generally well enough to participate in a clinical study?
- Do you have any serious heart conditions, badly controlled diabetes, or certain other health issues?
What does participation involve?
If you decide to take part in this study, you'll be assigned to receive Opevesostat, either by itself or in combination with other prostate cancer medications. You'll have regular hospital visits for check-ups, blood tests, scans, and to get your study medication. The frequency of visits and tests will depend on which stage of the study you are in and the treatment you receive.
Doctors and nurses will closely monitor your health and any side effects throughout the study. The total duration of your participation will vary, but it will involve ongoing treatment and follow-up appointments. More detailed information, including the exact schedule of visits and assessments, will be provided by the study team.
Potential risks and benefits
Locations (77)
- UCSD Moores Cancer Center ( Site 0039)Verified postcodeLa Jolla, United States· Recruiting
- UCLA Hematology/Oncology - Santa Monica ( Site 0044)Verified postcodeLos Angeles, United States· Recruiting
- University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)Verified postcodeMiami, United States· Recruiting
- University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)Verified postcodeBaltimore, United States· Active not recruiting
- Rutgers Cancer Institute of New Jersey ( Site 0033)Verified postcodeNew Brunswick, United States· Active not recruiting
- University Hospitals Cleveland Medical Center ( Site 0043)Verified postcodeCleveland, United States· Recruiting
- MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)Verified postcodeMilwaukee, United States· Recruiting
- Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)UnverifiedMacquarie University, Australia· Recruiting
- Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)Verified postcodeGreenslopes, Australia· Recruiting
- Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)Verified postcodeMelbourne, Australia· Recruiting
- Centre Hospitalier de l'Université de Montréal ( Site 0200)Verified postcodeMontreal, Canada· Recruiting
- Jewish General Hospital ( Site 0206)Verified postcodeMontreal, Canada· Recruiting
Common questions
What is 'metastatic castration-resistant prostate cancer'?
This is prostate cancer that has spread outside the prostate gland and is no longer controlled by standard hormone treatments which lower testosterone levels.
What is Opevesostat?
Opevesostat is a new medicine being tested in this study to see if it can help treat advanced prostate cancer. It is not yet approved for general use.
Will I definitely receive the new drug?
All participants will receive Opevesostat, either alone or combined with other prostate cancer medications. This study does not include a placebo group.
What medical conditions might stop me from joining?
Conditions like uncontrolled diabetes, recent serious heart problems, or certain infections that aren't well managed might mean you can't participate. Your study doctor can check this for you.
What does 'safety and efficacy' mean?
This means the study will first check how safe the new treatments are and what side effects they cause. Then, it will look at how well they actually work against the cancer.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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