All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

This research study, called MEVPRO-1, is for men with prostate cancer that has spread (metastatic) and is no longer responding to hormone treatment (castration-resistant). These men have already been treated with abiraterone acetate. The study aims to see if a new investigative medicine, PF-06821497, when given with enzalutamide, is better and safer than either enzalutamide or docetaxel alone, which are current standard treatments. Researchers want to find out if the new combination can slow down or stop the cancer from growing. It's a 'Phase 3' study, meaning it's a larger study designed to confirm effectiveness and safety before a new medicine can be considered for wider use.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
600
Start
21 Oct 2024
Estimated completion
29 Oct 2028

What is this study about?

This study is for men who have prostate cancer that has spread to other parts of their body and is no longer being controlled by standard hormone treatment, specifically abiraterone acetate. This type of cancer is called 'metastatic castration-resistant prostate cancer' (mCRPC).

The main goal of this particular study is to explore if a new medicine, known as PF-06821497 (also called Mevrometostat), when combined with another treatment called enzalutamide, can help control the cancer better than current standard treatments. These standard options include either enzalutamide by itself or a chemotherapy drug called docetaxel. The study focuses on whether the new combination is safer and more effective in stopping the cancer from growing or spreading further.

The researchers will primarily be looking at something called 'radiographic progression-free survival'. This means they will regularly take scans (like X-rays, CTs, or MRIs) to see if the cancer has grown or spread. If the cancer doesn't grow for a longer time with the new treatment combination, it would suggest the treatment is working well. Your doctor can give you more details if you are interested in this study.

Key takeaways

  • Targets men with advanced prostate cancer (mCRPC) previously treated with abiraterone.
  • Compares a new combination (PF-06821497 + enzalutamide) to standard treatments.
  • Aims to see if the new combination can better slow down cancer growth.
  • Participation involves regular clinic visits, medication, and scans.
  • You have the right to leave the study at any time.

Who may be eligible?

To join this study, you would need to be a man with prostate cancer that has spread and is no longer responding to hormone treatment, and you must have previously received abiraterone acetate. Your cancer must have been confirmed by a doctor, and there should be clear signs that it has spread, either in your bones (seen on a bone scan) or in other parts of your body (seen on a CT or MRI scan). You also need to be generally well enough to take part, with doctors expecting you to live for at least another six months. Your ability to carry out daily activities will be assessed.

However, there are some reasons why you might not be able to join. For example, if you have other serious medical conditions like certain heart problems, active inflammatory stomach/gut issues, or if scans show that your cancer has spread to your brain. You also can't have received certain prostate cancer treatments recently, such as most forms of chemotherapy, specific hormone therapies (like enzalutamide, apalutamide, darolutamide), or other experimental treatments, within a certain period before the study starts. There are a few exceptions, like certain older hormone blockers or specific use of docetaxel long ago.

Your study doctor will carefully review your full medical history and all your current health details to determine if this study is suitable for you. They will explain all the criteria in detail.

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 diagnosed with prostate cancer that has spread?
  2. Has your prostate cancer become resistant to standard hormone treatment?
  3. Have you previously been treated with abiraterone acetate for your prostate cancer?
  4. Are you generally well enough to participate in a study, assessed by your doctor?
  5. Do you have any serious heart conditions or inflammatory bowel diseases?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of three treatment groups. This means neither you nor your doctor can choose which treatment you receive; it's decided by chance, like flipping a coin. You will receive either the new study medicine (PF-06821497) combined with enzalutamide, enzalutamide on its own, or docetaxel (chemotherapy).

Taking part will involve regular visits to the hospital or clinic for medical check-ups. During these visits, doctors will monitor your health, give you the study medication, perform blood tests, and conduct imaging scans (like CT scans or bone scans) to see how your cancer is responding. These follow-up visits will be important to track your progress and check for any side effects.

The total duration of your participation in the study will depend on how your cancer responds to the treatment and for how long you can safely receive the medication. Even after you stop the study treatment, there will likely be follow-up visits or phone calls to monitor your long-term health and any ongoing effects.

Potential risks and benefits

Participating in a clinical trial may offer some potential benefits. You would receive cutting-edge medical care and access to a new treatment that isn’t yet widely available, which might work better than current options for your type of cancer. However, there are also potential risks involved. The new medicine, like all medications, can have side effects, some of which might be serious or currently unknown. You will be closely monitored for any reactions, but it's important to understand that the treatment might not work for you, or it could even make your condition worse. You have the right to withdraw from the study at any time, for any reason, without this affecting your future medical care.

Locations (230)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Urology Centers of Alabama
    Verified postcode
    Homewood, United States
  • Ironwood Cancer & Research Centers
    Verified postcode
    Chandler, United States
  • Ironwood Cancer & Research Centers
    Verified postcode
    Gilbert, United States
  • Ironwood Cancer & Research Centers
    Verified postcode
    Glendale, United States
  • Ironwood Cancer & Research Centers
    Verified postcode
    Mesa, United States
  • Ironwood Cancer & Research Centers
    Verified postcode
    Mesa, United States
  • Ironwood Cancer & Research Centers
    Verified postcode
    Phoenix, United States
  • Ironwood Cancer & Research Centers
    Verified postcode
    Scottsdale, United States
  • Los Angeles Cancer Network
    Verified postcode
    Anaheim, United States
  • UCSF Cancer Center Berkeley
    Verified postcode
    Berkeley, United States
  • UCSF Cancer Center Burlingame
    Verified postcode
    Burlingame, United States
  • Los Angeles Cancer Network
    Verified postcode
    Fountain Valley, United States

Common questions

What is 'metastatic castration-resistant prostate cancer'?

It's prostate cancer that has spread to other parts of your body (metastatic) and is no longer being controlled by treatments that lower testosterone (castration-resistant).

What is a 'Phase 3' study?

Phase 3 is a larger study that compares a new treatment to existing ones to confirm if it's effective and safe before it can be considered for approval.

Why do I need to have taken abiraterone acetate before?

This study is specifically looking at how the new treatment works in men whose cancer has progressed after having received abiraterone acetate.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning you and your doctor will know which treatment you are receiving.

What does 'radiographic progression-free survival' mean?

It's how long you live without your cancer growing or spreading when measured by medical scans like X-rays, CT, or MRI.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.