Active — Not RecruitingPhase 3

A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

United States600 participantsStarted 2024-10-21

Plain-language summary

Pfizer MEVPRO-1 (C2321014) is a randomized, open-label, multi-center clinical trial evaluating whether combining the study medicine (PF-06821497) with enzalutamide is safe and effective compared to physician's choice of either second-line androgen receptor (AR) directed therapy with enzalutamide or docetaxel (chemotherapy) for treating metastatic castration-resistant prostate cancer (mCRPC) after progression on prior abiraterone acetate treatment. The primary objective of this clinical trial is to assess the radiographic progression free survival (rPFS) of the combination of PF-06821497 plus enzalutamide versus physician's choice of enzalutamide or docetaxel.

Who can participate

Age range18 Years

SexMALE

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Exclusion criteria

✕. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention.
✕. 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.
✕. Use of 5-alpha reductase inhibitors within 28 days of randomization.

What they're measuring

Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

Timeframe: Randomization up to approximately 2 years.

Trial details

NCT IDNCT06551324

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-13

View on ClinicalTrials.gov More Metastatic Castrate Resistant Prostate Cancer (mCRPC) trials