You are not out of options

Enrolling people with metastatic castrate-resistant prostate cancer

The MEVPRO-1 clinical trial is exploring a potential treatment for men who have metastatic prostate cancer which is not responding to hormone therapy.  
The purpose of MEVPRO-1 is to see if taking the study medicine (mevrometostat) alongside a standard treatment (enzalutamide) is safe and works to slow down or stop the growth of metastatic prostate cancer compared with standard treatment alone (either enzalutamide or docetaxel).
The MEVPRO-1 clinical trial may be an option for men with metastatic castrate-resistant prostate cancer that has become resistant to hormone therapy. Participants must have previously been treated with abiraterone acetate, also known as Zytiga®, for at least 12 weeks and the Zytiga® has stopped working.

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., open-label‘Open-label’ means that both you and the study doctor will know which treatment you are receiving. clinical trial, which means that all enrolled participants will know their assigned study treatment. Participants will need to visit the study site about every 2-4 weeks during the study treatment period and every 12 weeks during follow up. Total length of study participation varies based on how your cancer responds and how well you tolerate the study medicine.

For information about the MEVPRO study medicine, please watch the short video below.

Thank you for considering the MEVPRO-1 clinical trial.

Who may participate

The MEVPRO-1 clinical trial may be an option for adults with metastatic castrate-resistant prostate cancer if you:
  • Have metastatic prostate cancer that has become resistant to hormone therapy.
  • Have previously been treated with abiraterone acetate (Zytiga ®) for at least 12 weeks and the Zytiga® has stopped working.
  • Have not received chemotherapy since the cancer became resistant to hormone therapy.
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-1 clinical trial, you will receive care from a skilled team of healthcare providers all working toward finding the next treatment for prostate cancer.
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.

Condition


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Metastatic castrate resistant prostate cancer

Age
The age a person must be to participate in a clinical trial.

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 the studies in this program. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Male

What to expect

Approximately 600 participants will be randomly (by chance) assigned to 1 of 2 treatment groups.

50% of participants will receive:

  • The study medicine (mevrometostat) taken as tablets by mouth with food, twice-per-day in combination with
  • Enzalutamide taken as capsules by mouth, once-per-day

50% of participants will receive:

  • Enzalutamide taken as capsules by mouth, once-per-day or
  • Docetaxel given as an IV (infusion into the vein) once every 3 weeks

A résztvevők 50%-a kapja a következőket:

  • Enzalutamid kapszula szájon át, naponta egyszer vagy
  • Docetaxel iv. (vénába adott infúzió) 3 hetente egyszer
The decision between enzalutamide or docetaxel will be made by the study doctor, who will then inform the participant of the chosen treatment.
There is no placebo (inactive medicine) given in this clinical trial.
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 your 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 2-4 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 12 weeks

Potential benefits and risks of taking part in the MEVPRO-1 clinical trial

People who take part in clinical trials are key to advancing medical research. By taking part in the MEVPRO-1 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 program may include vomiting, diarrhoea, weight loss, decreased appetite, altered sense of taste, hair loss, nausea (feeling sick to your stomach), 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 (mevrometostat) 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 have a visit approximately every 2-4 weeks, depending on how long you are participating in the trial.

Within a month after your last dose of the study treatment you receive, you will have an end-of-treatment visit. After this visit, you will enter the follow-up phase and will have a visit in approximately 28 to 35 days to check in on your health. You will then be contacted approximately every 12 weeks so the study team can 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-1 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-1 study site near you

The MEVPRO-1 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:
How clinical trials work
Steps to join a clinical trial
Protecting your safety & privacy
FAQs