The MEVPRO-3 clinical trial is exploring a new potential treatment for adults who have metastatic castration-sensitive prostate cancer (mCSPC).
The purpose of MEVPRO-3 is to see if taking the study medicine (mevrometostat) alongside a standard treatment (enzalutamide) will work better than enzalutamide alone to stop the growth of metastatic castration-sensitive prostate cancer.
Watch a short video about the study medicine
About mevrometostat
The study medicine is called mevrometostat and is taken as tablets by mouth twice-a-day.
Prostate cancer cells need hormones (such as testosterone) to grow and divide and can often become resistant to hormone therapy and continue to progress and spread to other parts of the body.
EZH2 is a gene that produces proteins which control the growth of cells. In people with prostate cancer this gene often produces too much EZH2 protein, which can cause the prostate cancer to progress.
Mevrometostat, the study medicine, is thought to work by blocking the abnormal EZH2 activity in cells, which may help prevent or delay hormone therapy resistance and cancer growth and progression.
Who may participate
The MEVPRO-3 clinical trial may be an option for adults with metastatic castration-sensitive prostate cancer.
If you have started receiving any further treatments (such as chemotherapy or a different hormone therapy) since your cancer was diagnosed as metastatic castration-sensitive, then this trial is not a good fit for you.
Condition
Metastatic Prostate Cancer
Age
18+ years
Sex
Male
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Get started — See if you may be eligible
Answer a 2-minute questionnaire.
A first step as you consider this study is to answer a 2-minute online questionnaire about your health and medical history. You will also be asked to provide your zip code, which may be used by Pfizer, and our partners working on this study to help improve the study recruitment process. If your answers show the study might be a good fit for you, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.
Speak with a study representative.
If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your medical history to see if you may be able to participate and be referred to a study clinic that you select.
Confirm your eligibility.
Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
What to expect
All participants will receive enzalutamide, which is the current standard treatment for this type of cancer. You will also be assigned to receive either mevrometostat or a placebo in addition to enzalutamide. A placebo looks like the study medicine but has no active ingredients in it, and is used in this clinical trial to see how the study medicine works by comparing any effects in the participants taking both study medicine and enzalutamide compared to those only taking enzalutamide.
You will have a 50% (1/2) chance of receiving the study medicine, a 50% (1/2) chance of receiving the placebo, and a 100% chance of receiving enzalutamide. Participants will be assigned to their treatment group by chance (like flipping a coin) rather than by choice. This is called randomization, and it is one way to help avoid bias in a study.
The study medicine (mevrometostat) and placebo are each taken as tablets by mouth twice-a-day. Enzalutamide is taken as capsules by mouth once-a-day.
You will attend clinic visits every 4 to 8 weeks during treatment, a follow-up 4 to 5 weeks after, then long-term follow-up every 8 to 12 weeks.
Length of study treatment
Depends on how the cancer responds and how well the study medicine is tolerated
Number of study visits
One visit every 4 to 8 weeks during treatment
Long-term follow up
Every 8 to 12 weeks
Frequently asked questions
Study visits may last about 2 to 3 hours. Participants will need to visit the study site about once every 4 to 8 weeks until the end of treatment. Participants taking enzalutamide with or without mevrometostat will continue until their cancer worsens, they have any side effects that become too severe, they or their doctor decide they should stop, or the trial ends.
There are no guaranteed benefits to joining a clinical trial. You will have regular visits to the study site and your health and cancer will be closely monitored for the duration of the clinical trial. Participating in clinical trials helps researchers learn more about the disease and advance potential treatment options.
Participant safety is the top priority of this clinical trial. It is possible your condition or health may improve, worsen, or stay the same. Your study doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll.
Your participation in this clinical trial is completely voluntary. You can choose to stop participating at any time, for any reason. Choosing not to participate in this clinical trial will not affect your future medical care or prostate cancer treatment.
What happens at each study visit will vary, but may include questions about your medical history, medications, physical exams, blood draws, biopsies (optional), electrocardiograms (ECGs), and CT/MRI/bone scans.
After you have finished taking the study medicine, you will enter the follow-up period, during which the researchers will continue to monitor the effects of the study medicine and potential side effects.
It is necessary for researchers to understand if there is a change in the risks or benefits of a study medicine over time. That is why it is important for you to stay in contact with the study team. The more information they have, the better they can determine how safe and how well a study medicine works. Thank you for your ongoing participation.
