A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
This research study is looking into a new medicine called opevesostat. It's being tested in men with prostate cancer that has spread to other parts of the body (metastatic) and is resistant to standard hormone treatment (castration-resistant). These men have also already received one other hormone-based medicine. The main goal is to see if opevesostat, when given with hormone replacement therapy, works better than abiraterone (Zytiga) or enzalutamide (Xtandi) at slowing down or stopping the cancer from growing further, and if it's safe to use. We want to find out if opevesostat can keep the cancer from spreading on scans for longer. The study also looks at how long people live overall.
At a glance
What is this study about?
This clinical study is designed for men who have prostate cancer that has spread to other parts of their body, known as metastatic prostate cancer. For this type of cancer, standard hormone treatments often work well for a while. However, over time, the cancer can become 'castration-resistant,' meaning it no longer responds effectively to those hormone treatments.
In this study, researchers are comparing a new potential medicine called opevesostat with two commonly used treatments, abiraterone (Zytiga) or enzalutamide (Xtandi). Participants in this study would have already tried one other next-generation hormone-based medicine for their prostate cancer. The main aim is to find out if opevesostat is better at slowing down or stopping the cancer from growing and spreading, as seen on scans. They also want to understand if opevesostat is safe and what side effects it might have.
Ultimately, the hope is that this study will help us understand if opevesostat could become a new, effective treatment option for men in this situation, potentially offering another way to manage their prostate cancer and improve their quality of life.
Key takeaways
- This study tests a new prostate cancer drug, opevesostat, for men whose cancer has spread.
- It's for men whose cancer no longer responds to standard hormone treatment and who have already tried one other modern hormone drug.
- Opevesostat is compared to existing treatments like abiraterone or enzalutamide.
- The main goal is to see if opevesostat is better at stopping cancer growth on scans and if it's safe.
- Participation involves regular clinic visits, tests, and scans to monitor your health.
Who may be eligible?
To join this study, you would need to be a man with prostate cancer that has been confirmed by a biopsy and has spread to other parts of your body. Your cancer must have stopped responding to standard hormone therapy, and you would have already been treated with one other modern hormone-based medicine (like abiraterone or enzalutamide) for at least 8 weeks (or 14 weeks if your cancer has spread to your bones).
It's important that your testosterone levels are low and that your general health is good enough to participate, as assessed by a doctor. You would also need to provide a recent tumour tissue sample. There are other specific health checks and tests involved to make sure the study is a good fit for you and safe.
- Have I been diagnosed with prostate cancer that has spread?
- Is my prostate cancer considered 'castration-resistant' (not responding to standard hormone therapy)?
- Have I already been treated with one other modern hormone-based medicine for my prostate cancer?
- Am I generally in good health, as assessed by doctor?
- Can I provide a recent tumour tissue sample?
- Are my testosterone levels currently low?
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 would receive either the new medicine, opevesostat (along with hormone replacement therapy), or one of the standard treatments (abiraterone or enzalutamide), depending on what the study assigns you. You would have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and the cancer's progress. These visits are important for the research team to see how you're responding to the treatment and to keep an eye on any side effects.
Exactly how often you would visit and for how long depends on the treatment and how you respond. The study will also involve follow-up care to track your health even after you stop taking the study medicine. The total duration of your participation could vary, but the team will explain all the details thoroughly.
Potential risks and benefits
Locations (327)
- The University of Arizona Cancer Center - North Campus ( Site 0073)Tucson, United States· Recruiting
- UCLA Hematology/Oncology - Santa Monica ( Site 0044)Los Angeles, United States· Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)Orange, United States· Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)Orange, United States· Recruiting
- Stanford Cancer Center ( Site 0036)Palo Alto, United States· Recruiting
- Emad Ibrahim,MD,INC. ( Site 0012)Redlands, United States· Completed
- Kaiser Permanente Riverside Medical Center ( Site 0099)Riverside, United States· Recruiting
- University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)Sacramento, United States· Recruiting
- San Francisco VA Health Care System ( Site 0093)San Francisco, United States· Recruiting
- Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)Vallejo, United States· Recruiting
- University of Colorado Anschutz Medical Campus ( Site 0046)Aurora, United States· Recruiting
- UCHealth Highlands Ranch Hospital ( Site 0111)Highlands Ranch, United States· Recruiting
+315 more sites — see the official record for the full list.
Common questions
What is 'metastatic castration-resistant prostate cancer'?
It means your prostate cancer has spread to other parts of your body (metastatic) and is no longer being controlled by standard hormone treatments (castration-resistant).
What is opevesostat?
Opevesostat is a new medicine being tested in this study to see if it can help slow down or stop prostate cancer growth.
Why do I need hormone replacement therapy if I take opevesostat?
Opevesostat may affect hormone levels, so hormone replacement therapy is given alongside it to help manage any potential side effects related to hormone imbalance.
Will I definitely get the new medicine?
This is a comparison study, so you might receive opevesostat or one of the standard treatments (abiraterone or enzalutamide). You won't get to choose which one.
How long will I be in the study?
The duration can vary. You will continue treatment for as long as it is helping and you are tolerating it well. There will also be follow-up observations after you stop treatment.
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
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.