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.

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate

In brief

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.

Key facts

Study ID

NCT07028853

Run by

Pfizer

People needed

1000

Starts

2025-09-28

Expected to finish

2034-12-08

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Chandler, Arizona, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Gilbert, Arizona, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Glendale, Arizona, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Goodyear, Arizona, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Mesa, Arizona, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Mesa, Arizona, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Phoenix, Arizona, United States (enrolling)
• Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Scottsdale, Arizona, United States (enrolling)
• Highlands Oncology Group, PA — Fayetteville, Arkansas, United States (enrolling)
• Highlands Oncology Group, PA — Rogers, Arkansas, United States (enrolling)
• Highlands Oncology Group, PA — Springdale, Arkansas, United States (enrolling)
• UCLA Hematology/Oncology - Alhambra — Alhambra, California, United States (enrolling)
• UCLA Hematology/Oncology - Atascadero — Atascadero, California, United States (enrolling)
• Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location) — Beverly Hills, California, United States (enrolling)
• Cedars-Sinai Cancer Beverly Hills — Beverly Hills, California, United States (enrolling)
• UCLA Hematology/Oncology - Beverly Hills — Beverly Hills, California, United States (enrolling)
• UCLA Hematology/Oncology - Burbank — Burbank, California, United States (enrolling)
• UCLA Hematology/Oncology - Encino — Encino, California, United States (enrolling)
• UCLA Hematology/Oncology - Irvine — Irvine, California, United States (enrolling)
• UCLA Hematology/Oncology - Laguna Hills — Laguna Hills, California, United States (enrolling)
• Cedars-Sinai Cancer at Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Ronald Reagan UCLA Medical Center - Drug Information Center — Los Angeles, California, United States (enrolling)
• UCLA Department of Medicine - Hematology/Oncology — Los Angeles, California, United States (enrolling)
• Clearview Cancer Institute (Crestwood) — Huntsville, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.