RightFit
RecruitingPhase 3

This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the study drug mevrometostat plus enzalutamide works better than enzalutamide alone. It is for men with prostate cancer that has spread and still responds to hormone-lowering treatment (mCSPC). They must not have taken newer hormone-blocking drugs called ARPIs or had chemotherapy for mCSPC.

This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older, or the minimum age to consent under local rules.
  • Prostate cancer called adenocarcinoma, confirmed by a tissue or cell test, with no small cell features.
  • Cancer that has spread, shown on a bone scan, CT scan, or MRI.
  • Side effects from past treatment have returned to their earlier level or are mild, unless the study doctor says they pose no safety risk.
  • Able to do all usual activities, or limited only in hard physical activity.

Who can't join

  • A health condition, mental health condition, or abnormal lab result that makes joining unsafe or unsuitable. This includes current suicidal thoughts or actions, or any within the past year.
  • Serious heart or blood vessel disease, or organs that do not work well enough.
  • Known or suspected cancer spread to the brain, or active cancer in the tissues covering the brain and spinal cord.
  • Past treatment for mCSPC, including chemotherapy. Older hormone-blocking drugs are allowed.
  • Use of an experimental drug or vaccine within the past 30 days.
  • Use of drugs called 5-alpha reductase inhibitors within 28 days before study group assignment, or current or expected need for drugs that strongly affect liver enzymes called CYP3A4/5. Study enzalutamide is allowed.
  • Not fully recovered from surgery at least 28 days before study group assignment.
  • Known allergy to mevrometostat, enzalutamide, or any of their ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease). * Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement). * Participants must have ECOG PS 0 or 1. Exclusion Criteria * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Clinically significant cardiovascular disease. * Known or suspected brain metastasis or active leptomeningeal disease. * Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC. * Previous administration with an investigational product (drug or vaccine) within 30 days. * Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization. * Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization * Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study). * Inadequate organ function. * Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.

Study sites (127)

AL

AR

AZ

CA

CO

FL

GA

IL

MI

NC

NJ

NY

OH

OK

PA

SC

TN

TX

  • University of Texas Southwestern Medical Center - Simmons Cancer Center · Dallas, TX 75235More trials in Dallas
  • University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital · Dallas, TX 75235More trials in Dallas
  • University of Texas Southwestern Simmons Cancer Center - Redbird · Dallas, TX 75237More trials in Dallas
  • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital · Dallas, TX 75390More trials in Dallas
  • University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
  • University of Texas Southwestern Simmons Cancer Center - Fort Worth · Fort Worth, TX 76104More trials in Fort Worth
  • US Oncology Investigational Product Center (IPC) · Irving, TX 75063More trials in Irving
  • University of Texas Southwestern Simmons Cancer Center - Richardson/Plano · Richardson, TX 75080More trials in Richardson

UT

VA

WA

WI

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center · Madison, WI 53718More trials in Madison
  • University of Wisconsin Carbone Cancer Center - University Hospital · Madison, WI 53792More trials in Madison