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Clinical Trials in China / NCT06629779
Recruiting Phase 3

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

NCT06629779 · tracked via the Priya Life Science China tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2024-10-22
Last updated
2026-08-24

Condition(s) studied

Metastatic Castration-Resistant Prostate Cancer

Investigational drug(s) / intervention(s)

PF-06821497PlaceboEnzalutamide

PF-06821497: Oral continuous

Placebo: Oral continuous

Enzalutamide: Oral continuous

Study summary

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan. * Progressive disease in the setting of medical or surgical castration. * ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator. Exclusion Criteria: * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study. * Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery. * Clinically significant cardiovascular disease. * Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure. * Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions. * Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions: 1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate; 2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion. * Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer). * Inadequate organ function.

Primary outcome measure(s)

Trial sites (236)

FacilityCityRegionStatus
Ironwood Cancer & Research Centers Chandler Arizona Recruiting
Ironwood Cancer & Research Centers Gilbert Arizona Recruiting
Palo Verde Hematology Oncology Glendale Arizona Recruiting
Ironwood Cancer & Research Centers Glendale Arizona Recruiting
Ironwood Cancer & Research Centers Goodyear Arizona Recruiting
Ironwood Cancer & Research Centers Mesa Arizona Recruiting
Ironwood Cancer & Research Centers Mesa Arizona Recruiting
Ironwood Cancer & Research Centers Phoenix Arizona Recruiting
Ironwood Cancer & Research Centers Scottsdale Arizona Recruiting
Highlands Oncology Fayetteville Arkansas Recruiting
Arkansas Urology - Little Rock Little Rock Arkansas Recruiting
Highlands Oncology Rogers Arkansas Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
Los Angeles Cancer Network (LACN) Anaheim California Recruiting
Los Angeles Cancer Network (LACN) Fountain Valley California Recruiting
Los Angeles Cancer Network (LACN) Glendale California Recruiting
Los Angeles Cancer Network (LACN) Glendale California Recruiting
Los Angeles Cancer Network (LACN) Laguna Hills California Recruiting
Los Angeles Cancer Network (LACN) Los Angeles California Recruiting
Los Angeles Cancer Network (LACN) Los Angeles California Recruiting
Medical Oncology Associates of San Diego San Diego California Recruiting
Accellacare of Duly Lisle Illinois Recruiting
Duly Health and Care (Bone Scintigraphy) Lisle Illinois Recruiting
Blessing Hospital Quincy Illinois Recruiting
Blessing Physician Services Quincy Illinois Recruiting
Duly Health and Care (CT and MRI) Westmont Illinois Recruiting
Adult & Pediatric Urology, PC Omaha Nebraska Recruiting
CHRISTUS St. Vincent Regional Cancer Center Santa Fe New Mexico Recruiting
Montefiore Medical Center - Medical Park The Bronx New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
AUC Urologists, LLC Myrtle Beach South Carolina Recruiting
Carolina Urologic Research Center, LLC Myrtle Beach South Carolina Recruiting
Grand Strand Medical Center Myrtle Beach South Carolina Recruiting
Parkway Surgery Center Myrtle Beach South Carolina Recruiting
USA Clinical Trials San Antonio Texas Recruiting
Northwest Medical Specialties, PLLC Bonney Lake Washington Recruiting
Northwest Medical Specialties, PLLC Federal Way Washington Recruiting
Northwest Medical Specialties, PLLC Gig Harbor Washington Recruiting
Northwest Medical Specialties, PLLC Puyallup Washington Recruiting
Harborview Medical Center Seattle Washington Recruiting

+ 196 more sites — see the full list on the official registry below.

On this site

📄 Xtandi (enzalutamide) drug profile →

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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 NCT06629779 on ClinicalTrials.gov ↗ ← All trials in China