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Clinical Trials in the UK / NCT07028853
Recruiting Phase 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.

NCT07028853 · tracked via the Priya Life Science UK tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2025-09-28
Last updated
2026-08-14

Condition(s) studied

Metastatic Castration Sensitive Prostate Cancer (mCSPC)Hormone Sensitive Prostate CancerProstate CancerCancer of the Prostate

Investigational drug(s) / intervention(s)

MevrometostatPlaceboEnzalutamide

Mevrometostat: Oral continuous

Placebo: Oral continuous

Enzalutamide: Oral continuous

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (337)

FacilityCityRegionStatus
Clearview Cancer Institute (Crestwood) Huntsville Alabama Recruiting
Clearview Cancer Institute Huntsville Alabama Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Chandler Arizona Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Gilbert Arizona Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Glendale Arizona Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Goodyear Arizona Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Mesa Arizona Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Mesa Arizona Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Phoenix Arizona Recruiting
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Scottsdale Arizona Recruiting
Highlands Oncology Group, PA Fayetteville Arkansas Recruiting
Highlands Oncology Group, PA Rogers Arkansas Recruiting
Highlands Oncology Group, PA Springdale Arkansas Recruiting
UCLA Hematology/Oncology - Alhambra Alhambra California Recruiting
UCLA Hematology/Oncology - Atascadero Atascadero California Recruiting
Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location) Beverly Hills California Recruiting
Cedars-Sinai Cancer Beverly Hills Beverly Hills California Recruiting
UCLA Hematology/Oncology - Beverly Hills Beverly Hills California Recruiting
UCLA Hematology/Oncology - Burbank Burbank California Recruiting
UCLA Hematology/Oncology - Encino Encino California Recruiting
UCLA Hematology/Oncology - Irvine Irvine California Recruiting
UCLA Hematology/Oncology - Laguna Hills Laguna Hills California Recruiting
Cedars-Sinai Cancer at Cedars-Sinai Medical Center Los Angeles California Recruiting
Ronald Reagan UCLA Medical Center - Drug Information Center Los Angeles California Recruiting
UCLA Department of Medicine - Hematology/Oncology Los Angeles California Recruiting
UCLA Hematology/Oncology Los Angeles California Recruiting
UCLA Hematology/Oncology - Marina del Rey Marina del Rey California Recruiting
UCLA Hematology/Oncology - Pasadena Pasadena California Recruiting
UCLA Hematology/Oncology - Porter Ranch Porter Ranch California Recruiting
UCLA Hematology/Oncology - San Luis Obispo San Luis Obispo California Recruiting
UCLA Hematology/Oncology - Santa Barbara Santa Barbara California Recruiting
UCLA Hematology/Oncology- Santa Monica Santa Monica California Recruiting
UCLA Hematology/Oncology - Torrance Torrance California Recruiting
UCLA Hematology/Oncology - Santa Clarita Valencia California Recruiting
UCLA Hematology/Oncology - Ventura Ventura California Recruiting
UCLA Hematology/Oncology - Westlake Westlake Village California Recruiting
AdventHealth Medical Group Urology of Denver Denver Colorado Recruiting
Advanced Urology Institute, LLC Largo Florida Recruiting
Tennessee Oncology, PLLC - Dalton Dalton Georgia Recruiting
Tennessee Oncology, PLLC - Ringgold Ringgold Georgia Recruiting

+ 297 more sites — see the full list on the official registry below.

On this site

📄 Xtandi (enzalutamide) drug profile →

More Pfizer trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07028853 on ClinicalTrials.gov ↗ ← All trials in the UK