RecruitingMetastatic Castration Sensitive Prostate Cancer (mCSPC)Hormone Sensitive Prostate CancerProstate Cancer

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.

Eligible age

18+ yrs

Accepts

Men

Locations

21 states

Healthy volunteers

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About this study

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.

Sponsor: Pfizer

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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).