Pfizer | MEVPRO-3 | NCT07028853

About

Prostate cancer is one of the most common types of cancer in men. In metastatic castration-sensitive prostate cancer (mCSPC), the cancer has spread beyond the prostate, typically to bone, but still responds to hormone-lowering therapy. Treatment can slow the disease, but it eventually stops working in most men, and the cancer becomes harder to control. Spread to bone can cause pain, fractures, and fatigue, reducing quality of life. New combination treatments are needed to keep the cancer controlled for longer.

Purpose

This Phase 3 study tests whether adding mevrometostat, an investigational pill that blocks a protein called EZH2 that helps cancer cells grow, to enzalutamide works better than enzalutamide alone. About 1,000 participants will be randomly assigned (1:1) to receive mevrometostat or a matching placebo, and everyone takes enzalutamide. Neither participants nor doctors will know who receives mevrometostat. The primary goal is to see whether the combination lengthens the time before the cancer worsens as detected by imaging. Safety and overall survival are also measured.

Eligibility

• Men with prostate adenocarcinoma that has spread (metastatic), confirmed by bone scan, CT, or MRI
• No prior treatment for metastatic disease other than up to 3 months of hormone therapy (ADT) or first-generation antiandrogens
• No known brain metastases and no clinically significant cardiovascular disease
• No current need for strong CYP3A4/5 drugs, and no allergy to mevrometostat or enzalutamide

Benefits

If you qualify for the study, all study-related medical care and treatment will be provided to you at no cost. You may receive a stipend for your participation in the study.

Send us a message if you are interested in participating in a study.