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.

Official record

Identifier

NCT07028853

Recruiting locations

countries

United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaChinaCzechiaFinlandFranceGermanyGreeceIsraelItalyJapanNetherlandsNew ZealandPolandSlovakiaSouth KoreaSpainSwitzerlandTaiwanTurkey (Türkiye)United Kingdom

Interventions studied

MevrometostatPlaceboEnzalutamide

Lead sponsor

Pfizer

Target enrolment

1000 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Jun 19, 2025

Last updated on the registry

Jul 30, 2026

Age

18 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.