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A Study of PF-06821497 (Mevrometostat) for Metastatic Prostate Cancer

This study is looking at a new combination treatment for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to standard hormone therapy. Researchers want to see if combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone. You might be able to join if you are a man aged 18 or older with mCRPC that has spread to your bones or soft tissues, and you haven't received certain other prostate cancer treatments. The main goal is to see how long people live without their cancer growing or spreading (radiographic progression-free survival), measured for up to about 3 years. This study plans to enroll 900 participants.

Study design
This is a global, multi-center study where participants will be randomly assigned to one of two groups: PF-06821497 plus enzalutamide, or a placebo plus enzalutamide. It plans to enroll 900 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and then for a longer period after treatment. The primary endpoint, radiographic progression-free survival, is measured for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06629779

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~900 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:PF-06821497PlaceboEnzalutamide

At a glance

Recruiting sites
235 of 236 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Progression Free Survival (rPFS)
Measured over Randomization up to approximately 3 years

Conditions

Metastatic Castration-Resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

236 sites across 130 states
Arizona9
California8
Washington8
Santiago Metropolitan6
Italy6
Illinois5
Ceará5
Taiwan5

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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.

What this trial measures

  • Radiographic Progression Free Survival (rPFS)Randomization up to approximately 3 years

    rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.