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RecruitingPHASE3INTERVENTIONAL

This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

This research is investigating a new drug called mevrometostat. It's being tested alongside a well-known prostate cancer treatment, enzalutamide. The study is for men with prostate cancer that has spread (metastatic) but is still responding to hormone therapy (castration-sensitive), and who haven't had specific anti-hormone treatments yet. The main goal is to see if taking mevrometostat together with enzalutamide is more effective than taking enzalutamide on its own. Participants will be randomly assigned to one of two groups: one receiving the new combination and the other receiving enzalutamide plus a placebo (a dummy drug). This helps researchers understand the true benefits of mevrometostat. The study will carefully follow participants to monitor their progress and safety.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
1,000
Start
28 Sep 2025
Estimated completion
08 Dec 2034

What is this study about?

This study is a clinical trial looking at a type of prostate cancer that has spread to other parts of the body, known as metastatic castration-sensitive prostate cancer (mCSPC). "Castration-sensitive" means the cancer still responds to treatments that lower testosterone levels.

The main aim of this research is to find out if a new drug, mevrometostat, when given alongside a standard treatment called enzalutamide, works better than enzalutamide by itself. Enzalutamide is a hormone therapy that blocks male hormone signals that can make cancer grow. Researchers want to see if adding mevrometostat can improve how well enzalutamide works for patients who haven't yet received certain types of hormone therapy for their advanced prostate cancer.

Participants in the study will be split into two groups by chance. One group will receive mevrometostat along with enzalutamide, while the other group will receive a placebo (a dummy pill, which looks like mevrometostat but contains no active drug) along with enzalutamide. Neither the patients nor their doctors will know which treatment they are receiving. This method helps ensure the study results are fair and accurate. The study will carefully monitor the health and progress of all participants over time.

Key takeaways

  • This study is for men with prostate cancer that has spread but still responds to hormone treatment.
  • It tests a new drug (mevrometostat) alongside an existing one (enzalutamide) versus enzalutamide alone.
  • The goal is to see if the combination works better than enzalutamide on its own.
  • Participants will be randomly assigned to one of two treatment groups, and neither they nor their doctor will know which group they are in.
  • Close medical monitoring will be provided throughout the study.

Who may be eligible?

To join this study, you must be a man aged 18 or older with prostate cancer that has spread to other parts of your body. Your cancer must have been confirmed by tests, and your body must be generally strong enough to cope with the study treatments, as assessed by the doctors.

There are also reasons why you might not be able to join. For example, if you have other serious medical conditions, especially heart problems or untreated brain cancer. You also can't have had certain strong anti-cancer treatments, like chemotherapy, for your advanced prostate cancer before, though some hormone therapies are allowed. If you've recently been part of another drug study or had major surgery, that might also prevent you from joining.

The research team will carry out several tests to make sure that taking part in the study is both safe and appropriate 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.

  1. Are you a man at least 18 years old?
  2. Do you have prostate cancer that has spread, confirmed by a doctor?
  3. Have you NOT received chemotherapy for your advanced prostate cancer?
  4. Are you generally well and active enough for daily life?
  5. Do you have any serious heart conditions or other major illnesses?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening phase where several tests are done to check if you're suitable. Once confirmed, you'll be randomly assigned to one of two groups: either you'll receive the new drug mevrometostat plus enzalutamide, or a placebo (dummy drug) plus enzalutamide. Neither you nor your doctor will know which group you are in.

You'll need to take the study medication regularly as instructed. There will be regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. This treatment phase will last for a period, followed by a safety follow-up period to track any side effects, and then a long-term follow-up to monitor your health over time. The exact number of visits and the full duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the new combination treatment proves to be more effective than the standard treatment alone. There's also the benefit of close medical monitoring throughout the study. However, there are potential risks, as any medication can have side effects. Mevrometostat is a new drug, so not all side effects are fully known, though careful monitoring will be in place. Enzalutamide also has known side effects. You can withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (329)

  • Clearview Cancer Institute (Crestwood)
    Verified postcode
    Huntsville, United States· Recruiting
  • Clearview Cancer Institute
    Verified postcode
    Huntsville, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Chandler, United States· Recruiting
  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
    Verified postcode
    Chandler, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Gilbert, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Glendale, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Goodyear, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Mesa, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Mesa, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Phoenix, United States· Recruiting
  • Ironwood Cancer & Research Centers
    Verified postcode
    Scottsdale, United States· Recruiting
  • Highlands Oncology Group, PA
    Verified postcode
    Fayetteville, United States· Recruiting

Common questions

What is metastatic castration-sensitive prostate cancer (mCSPC)?

This is prostate cancer that has spread to other parts of the body (metastatic) but still responds to treatments that lower testosterone (castration-sensitive).

What is enzalutamide?

Enzalutamide is a hormone therapy medication used to treat prostate cancer by blocking the signals that make cancer cells grow.

What is a placebo?

A placebo is a 'dummy' pill or treatment that looks exactly like the real drug but contains no active medicine. It helps researchers fairly compare the effects of the new drug.

Why don't I know if I'm getting the new drug or the placebo?

This 'double-blind' approach prevents bias. It means neither you nor your doctor knows which treatment you're receiving, ensuring the results are as accurate as possible.

Can I get other cancer treatments while in the study?

Generally, no. To get clear results, you can't have other anti-cancer treatments during the study, except for specific basic hormone therapies that might be allowed.

How to find out more

Pfizer CT.gov Call Center

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 "This Study Will Explore Whether a Combination of the Investi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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