RecruitingPHASE3INTERVENTIONAL

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

This study is for men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy (called metastatic castration-resistant prostate cancer, or mCRPC). Researchers want to find out if a new drug, PF-06821497 (also known as mevrometostat), when given together with an existing treatment called enzalutamide, is more effective than taking enzalutamide alone. All participants will take enzalutamide, but some will also receive the new drug and others a placebo. This study is for men who haven't previously taken certain types of hormone-blocking drugs, such as enzalutamide, darolutamide, apalutamide, or abiraterone. It's a Phase 3 study, meaning it's one of the final steps to see if the new medicine is safe and effective.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

900

Start

22 Oct 2024

Estimated completion

30 Nov 2028

Metastatic Castration-Resistant Prostate Cancer

What is this study about?

This study is focused on a type of prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to treatments that lower male hormones (castration-resistant). This is often called mCRPC. Doctors are looking for new ways to treat this condition.

The main goal of this study is to see if adding a new investigational drug, PF-06821497 (also known as mevrometostat), to an existing prostate cancer medicine called enzalutamide, helps prostate cancer patients more than enzalutamide alone. Enzalutamide is a commonly used treatment, and researchers want to find out if this new combination could be a better option for some men.

Participants in this study will be split into two groups by chance. One group will receive the new drug (PF-06821497) along with enzalutamide. The other group will receive a 'dummy' drug (placebo) along with enzalutamide. This allows researchers to compare the effects of the new drug combination against the standard treatment. The study is particularly looking for men who haven't had certain types of hormone treatments before, like enzalutamide, darolutamide, apalutamide, or abiraterone.

Key takeaways

This study is for men with advanced, hormone-resistant prostate cancer.
It tests a new drug (PF-06821497) combined with an existing one (enzalutamide).
Some participants will get the new drug, others a placebo, both with enzalutamide.
You must not have taken certain hormone-blocking drugs before.
Participation involves regular clinic visits, tests, and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adult men aged 18 or older with prostate cancer that has spread (metastatic) and is no longer responding to hormone therapy. We're looking for those who haven't previously taken certain types of hormone-blocking drugs like enzalutamide, darolutamide, apalutamide, or abiraterone.

You should also be generally well, able to perform daily activities, and have a good life expectancy as judged by the study doctor. Your prostate cancer must have been confirmed by a doctor, and it needs to be showing signs of progression despite being on hormone therapy.

There are also some reasons why you might not be able to join. For example, if you have certain other serious health problems like heart disease, active inflammatory bowel disease, or a history of specific blood conditions or brain tumours. You also can't have had certain other anti-cancer treatments recently, except for some specific types of hormone therapy or chemotherapy given much earlier in your treatment journey.

Quick self-check

Are you an adult male (18 or over)?
Do you have prostate cancer that has spread and is no longer responding to hormone therapy?
Have you NOT taken enzalutamide, darolutamide, apalutamide, or abiraterone for your prostate cancer?
Are you generally well and able to carry out your daily activities?
Do you have no other serious health conditions like significant heart or bowel disease?
Have you not had a brain tumour or active seizures?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, it will involve several stages: first, a screening phase to check if you're suitable. If you are, you'll be randomly assigned to one of two groups: either you'll receive the new drug PF-06821497 plus enzalutamide, or a dummy drug (placebo) plus enzalutamide. You won't get to choose which group you're in, and neither will the doctors.

You will continue with the assigned treatment for a certain period, which will involve regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. After the treatment phase, there will be safety follow-up checks, and then a longer-term follow-up to see how you are doing over time. The total duration of your participation will depend on how you respond to the treatment and the follow-up schedule.

Potential risks and benefits

By taking part, you might benefit from receiving a new, experimental treatment that could be more effective than current approaches, though this is not guaranteed. However, as with any medication, there's a possibility of side effects from the study drugs. These side effects can vary from mild to severe, and they will be carefully monitored by the study team. You'll receive regular medical care and close monitoring throughout the study. Remember, joining a clinical study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (240)

Ironwood Cancer & Research Centers
Chandler, United States· Recruiting
Ironwood Cancer & Research Centers
Gilbert, United States· Recruiting
Palo Verde Hematology Oncology
Glendale, United States· Recruiting
Ironwood Cancer & Research Centers
Glendale, United States· Recruiting
Ironwood Cancer & Research Centers
Goodyear, United States· Recruiting
Ironwood Cancer & Research Centers
Mesa, United States· Recruiting
Ironwood Cancer & Research Centers
Mesa, United States· Recruiting
Ironwood Cancer & Research Centers
Phoenix, United States· Recruiting
Ironwood Cancer & Research Centers
Scottsdale, United States· Recruiting
Highlands Oncology
Fayetteville, United States· Recruiting
Arkansas Urology - Little Rock
Little Rock, United States· Recruiting
Highlands Oncology
Rogers, United States· Recruiting

+228 more sites — see the official record for the full list.

Common questions

What is prostate cancer that has spread and is castration-resistant?

This is prostate cancer that has spread to other parts of your body (metastatic) and is no longer being controlled by treatments that lower your male hormone levels (castration).

What is a 'placebo'?

A placebo is a 'dummy' drug that looks exactly like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the new drug against not having it.

Will I know which treatment I am receiving?

No, in this type of study, neither you nor your doctor will know if you are receiving the new drug or the placebo. This helps ensure the results are accurate and unbiased.

What is a Phase 3 study?

A Phase 3 study is one of the final stages of clinical research. It involves a larger group of people to confirm if a new treatment is effective, safe, and works better than existing treatments.

Can I stop participating in the study at any time?

Yes, your participation is completely voluntary, and you can choose to leave the study at any point, for any reason, without it affecting your medical care.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.