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RecruitingPHASE3INTERVENTIONAL

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

This study, called MK-5684-003, is looking at a new medicine called Opevesostat for men with advanced prostate cancer. This is prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone therapy (castration-resistant). Participants in the study will be randomly assigned to receive either Opevesostat or another approved hormone treatment like abiraterone acetate or enzalutamide. The main goal is to find out if Opevesostat helps men live longer than these existing treatments. This is for men who have already had certain hormone therapies and some chemotherapy. The study will look at how the new drug works in prostate cancer with different gene changes.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
1,310
Start
31 Dec 2023
Estimated completion
15 Feb 2030

What is this study about?

This study is a Phase 3 clinical trial, which means it's a large, important study comparing a new medicine, Opevesostat, to existing standard treatments for advanced prostate cancer. Prostate cancer is considered advanced when it has spread beyond the prostate gland, often to bones or other organs. 'Castration-resistant' means the cancer is still growing even when hormone levels are kept very low by treatments. This trial aims to see if Opevesostat can offer a better option for men who have already received certain types of hormone therapy and chemotherapy, but their cancer has unfortunately come back or worsened.

The researchers believe that Opevesostat might help people live longer compared to the other common hormone treatments. They are particularly interested in how it works in people with different genetic features in their cancer cells. By comparing Opevesostat to standard treatments, the study hopes to gather clear evidence on whether this new medicine could become a valuable new treatment choice for men facing this challenging form of prostate cancer.

It's important to remember that all new medicines go through careful testing like this to ensure they are safe and effective. Taking part in such a study helps medical science advance and potentially discover better ways to treat serious conditions like advanced prostate cancer. The information from this study will help doctors understand if Opevesostat could be a new standard of care.

Key takeaways

  • This study is testing a new drug, Opevesostat, for advanced prostate cancer.
  • It's for men whose cancer has spread and is no longer responding to hormone therapy.
  • Participants must have already received certain hormone and chemotherapy treatments.
  • The main goal is to see if Opevesostat helps men live longer.
  • You would be randomly assigned to receive Opevesostat or a standard hormone treatment.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for men with prostate cancer that has spread and is no longer responding to hormone therapy. You would need to have had your prostate cancer diagnosed as adenocarcinoma (a common type of prostate cancer) and show that it has spread to other parts of your body. Your cancer should also have gotten worse while you were on hormone therapy within the last six months.

You would need to have already received one type of advanced hormone treatment and one or two chemotherapy treatments, and your cancer should have progressed after these. It's also important that your testosterone levels are low due to ongoing hormone therapy. You'll need to provide a recent tissue sample from your tumour, and generally be well enough to take part in a study, assessed by a common health check. You may have also had other specific treatments like PARP inhibitors or Lu-PSMA, or been advised not to have them, or decided not to have them.

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.

  1. I have prostate cancer that has spread to other parts of my body.
  2. My prostate cancer is still growing despite hormone treatments.
  3. I have already had one advanced hormone treatment for my prostate cancer.
  4. I have had one or two chemotherapy treatments for my prostate cancer.
  5. My testosterone levels are low because of ongoing hormone therapy.
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive either the new medicine, Opevesostat, or one of the standard hormone treatments (abiraterone acetate or enzalutamide). You might also take other medicines like hydrocortisone, fludrocortisone, prednisone, or dexamethasone, depending on your treatment group. Since it's an 'open-label' study, both you and your doctor will know which treatment you are receiving. You'll have regular hospital visits for check-ups, assessments, and to receive your medication. These visits will involve blood tests, scans, and physical exams to monitor your health and how your cancer is responding to treatment. The total duration of your participation will depend on how you respond to the treatment, but you will be followed carefully throughout the study and afterwards.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. A potential benefit of joining this study is getting access to a new medicine, Opevesostat, which might be more effective than existing treatments for your type of prostate cancer. However, there's no guarantee it will work for you, and it's possible it might not be better than current options. Like all medicines, Opevesostat and the standard treatments can have side effects, which your study team will explain in detail. You will be closely monitored for any reactions or health changes. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (282)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
    Verified postcode
    Orange, United States· Active not recruiting
  • Stanford Cancer Center ( Site 0036)
    Verified postcode
    Palo Alto, United States· Recruiting
  • Kaiser Permanente Riverside Medical Center ( Site 0099)
    Verified postcode
    Riverside, United States· Recruiting
  • Anschutz Cancer Pavilion ( Site 0046)
    Verified postcode
    Aurora, United States· Recruiting
  • University of Colorado Health - Highlands Ranch Hospital ( Site 0111)
    Verified postcode
    Highlands Ranch, United States· Recruiting
  • Colorado Clinical Research ( Site 0067)
    Verified postcode
    Lakewood, United States· Active not recruiting
  • University of Colorado Health - Lone Tree Medical Center ( Site 0112)
    Verified postcode
    Lone Tree, United States· Recruiting
  • Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
    Verified postcode
    New Haven, United States· Recruiting
  • Florida Cancer Specialists - South ( Site 7003)
    Verified postcode
    Fort Myers, United States· Recruiting
  • Bruce W. Carter Veterans Affairs Medical Center ( Site 0082)
    Verified postcode
    Miami, United States· Active not recruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051)
    Verified postcode
    Miami, United States· Recruiting
  • University of Illinois at Chicago ( Site 0105)
    Verified postcode
    Chicago, United States· Recruiting

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread to other parts of your body (metastatic) and is continuing to grow even with treatments to lower your testosterone (castration-resistant).

What is a Phase 3 study?

A Phase 3 study is a large study that compares a new treatment to existing standard treatments to see if the new treatment is better and safer.

Will I know if I'm getting the new drug?

Yes, this is an 'open-label' study, meaning both you and your doctor will know whether you are receiving Opevesostat or one of the standard treatments.

What kind of treatments have to have already had?

You'll need to have had one type of advanced hormone therapy and either one or two rounds of chemotherapy for your prostate cancer.

What if my cancer has not spread?

This study is specifically for men whose prostate cancer has spread to other parts of their body, so you would need to show evidence of this.

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?

Register your interest

Share your details and the research team for "Study of Opevesostat (MK-5684) Versus Alternative NHA in mCR…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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