Consider all of your options for metastatic prostate cancer

Enrolling adults with metastatic castration-sensitive prostate cancer

The MEVPRO-3 clinical trial is exploring a potential treatment for adults who have metastatic castration-sensitive prostate cancer (mCSPC). If you have started receiving any further treatments (such as chemotherapy or a different hormone therapy) for the metastatic setting, since your cancer was diagnosed as castration-sensitive, then this trial is not a good fit for you. If you have not received any treatment for mCSPC, with the exception of androgen-deprivation therapy, then this trial might be a good fit for you.
The purpose of MEVPRO-3 is to see if taking the study medicine alongside a standard treatment (enzalutamide) will work better than enzalutamide alone to slow down or stop the growth of metastatic castration-sensitive prostate cancer.
In this clinical trial, all participants will receive enzalutamide, which is the current standard treatment for this type of cancer. 50% of study participants will also receive the study medicine. The other 50% of study participants will receive a placebo medicine. Participants will receive attentive care and health assessments by the study team while in the clinical trial.

This is a phase 3‘Phase 3’ is the last phase of testing to be completed before the study drug is submitted for regulatory review and potential approval., placebo-controlled‘Placebo-controlled’ means that the clinical trial is comparing the study medicine to a placebo. A placebo does not have any active medicine but looks just like the medicine being studied., double-blind‘Double-blind’ means that neither you nor the study team will know whether you are receiving the study medicine or placebo. clinical trial, which means that the enrolled participants will not know their assigned study treatment. Participants will need to visit the study site about every 4-8 weeks during the study treatment period and every 8-12 weeks during long-term follow up. Total length of study participation varies based on how the cancer responds and how well you tolerate the study medicine.

For more information about the study medicine, please watch the short video below.
Thank you for considering the MEVPRO-3 clinical trial.

Who may participate

The MEVPRO-3 clinical trial may be an option for you if you:
  • Are at least 18 years of age or the minimum age of consent in your country
  • Have been diagnosed with metastatic castration-sensitive prostate cancer
  • Have not tried hormonal therapy apart from ADT and some types of hormone therapy such as oestrogens or first-generation anti-androgens, i.e. bicalutamide
  • Have not tried chemotherapy since becoming castration-sensitive

Other criteria may apply, which the study team will discuss with you.

People who take part in clinical trials are key to advancing medical research. By taking part in the MEVPRO-3 clinical trial, you will receive care from a skilled team of health care providers all working toward finding the next treatment for prostate cancer.

Condition


The disease, disorder, syndrome, illness or injury that is being studied.

Metastatic castration-sensitive prostate cancer

Age


The age a person must be to participate in a clinical trial.
Age
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18+ years*

*At least 18 years old or the minimum age of consent depending on local regulations.

Sex


The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.
Sex
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Male

What to expect

Approximately 1000 participants will be randomly (by chance) assigned to 1 of 2 treatment groups.
50% of participants will receive:
  • The study medicine taken as tablets by mouth with food, twice per day in combination with
  • Enzalutamide taken as capsules and/or tablets by mouth with or without food, once per day

50% of participants will receive:

  • A placebo taken as tablets by mouth with food, twice per day in combination with
  • Enzalutamide taken as capsules and/or tablets by mouth with or without food, once per day
Length of study treatment
Length of study treatment is the length of time the study participants will receive the treatments provided in the clinical trial.
Depends on how the cancer responds and how well you tolerate the study medicine
Number of study visits
Each clinical trial’s design specifies the number of study visits and the total length of the trial.
1 visit approximately every 4-8 weeks*

*The total number of study visits will vary depending on how long you are participating in the trial.

Extended follow up
Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the treatment part of the trial. This extended follow-up is to check in on your health status and see if you have started any new cancer treatments.
You will be contacted or asked to visit the study site every 8-12 weeks

Potential benefits and risks of taking part in the MEVPRO-3 clinical trial

People who take part in clinical trials are key to advancing medical research. By taking part in the MEVPRO-3 clinical trial, you will be advancing prostate cancer treatment research, which may help you and others with prostate cancer in the future.

Over the course of the clinical trial, a participant’s condition or health may improve, worsen or stay the same. People who are considering taking part in the clinical trial will be given a list of known risks and possible discomforts before agreeing to participate. As with taking any medicine, participants in clinical trials may experience side effects from the study treatment.

The potential side effects for the study treatment in this clinical trial may include vomiting, diarrhoea, weight loss, decreased appetite, altered sense of taste, hair loss, nausea (feeling like you're going to vomit), fatigue (feeling tired) and asthenia (low energy). The study team will discuss a full list of benefits and risks with you before you choose to enrol.

Frequently asked questions

The study medicine is thought to work by blocking the abnormal EZH2 activity of cells, which may help prevent or delay hormone therapy resistance and cancer growth and progression.

The informed consent document has a full list with descriptions of the tests, assessments and procedures that will be performed during the clinical trial. These may include blood draws, imaging scans, electrocardiograms, health and medication questions and more. The study team will discuss all of them with you.

The study team will perform tests and assessments throughout the clinical trial to monitor your health and safety as well as the effectiveness of the treatment you receive. 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. These visits will allow the study team to check in on your health and see if you have started any new cancer treatments. Some additional follow-up visits may be required, depending on how your disease changes over time.

Informed consent is one of the most important tools to help you understand how your rights, safety and well-being will be addressed throughout the trial.

During the informed consent discussion, you will be given all details about the clinical trial, including potential benefits and risks of taking part. You will also be given a document summarizing this information, which you will sign to confirm that you would like to take part in the clinical trial.

Yes, participation in clinical trials is completely voluntary; taking part in a trial is your choice. You are free to stop being in this trial at any time and for any reason, and it will not affect your future medical care in any way.

Clinical trials are important to understand more about potential treatment options for all sorts of conditions. Clinical trials also help us learn more about the effectiveness of a study medicine and the side effects of a potential treatment. These clinical trials help us understand whether the possible benefits outweigh the risks.

The study medicine and study-related care are provided at no cost. Please talk with the study team if you have any questions about potential financial costs associated with taking part in the MEVPRO-3 clinical trial.

Travel to the study site and other expenses (such as meals) may be covered.]Please discuss any potential travel support with your study team.

Find answers to other FAQs.

FAQs

Find a MEVPRO-3 study site near you

The MEVPRO-3 clinical trial is taking place in multiple countries worldwide.
To find your nearest study site, please enter your postal code and select the optimal distance to view on the map from the drop-down menu:

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