Tests mevrometostat with enzalutamide in men with early spreading prostate cancer
Tests mevrometostat plus enzalutamide, compared with enzalutamide alone, in adult men with prostate cancer.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Bologna, Meldola, Milan, Novara, Orbassano, Padova, Ravenna, Rome, Rozzano, Trento, and Verona, ItalySee the 11 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and still responds to hormone treatment. They must not have had an ARPI or chemotherapy for this stage yet.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma without small cell features that has spread (metastatic), shown on a bone scan, CT or MRI. Must be castration-sensitive (mCSPC).
- Earlier treatment
- No chemotherapy and no ARPI for metastatic castration-sensitive prostate cancer. First-generation antiandrogen treatment is allowed. Effects of earlier treatment must have settled to Grade 1 or milder.
Main reasons for not taking part
- Known or suspected brain metastasis or active leptomeningeal disease
- Clinically significant cardiovascular disease
- Use of 5-alpha reductase inhibitors within 28 days of randomization
- Current or expected use of strong CYP3A4/5 inhibitor or inducer drugs
- Allergy to mevrometostat or enzalutamide or their ingredients
Read by machine on 12 November 2026.
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNo longer taking part
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyNo longer taking part
- Istituto Oncologico VenetoPadova, ItalyNo longer taking part
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyNo longer taking part
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyNo longer taking part
- Humanitas Mirasole S.p.A.Rozzano, ItalyNo longer taking part
- Azienda Provinciale Per I Servizi SanitariTrento, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Pfizer
- Trial code
- NCT07028853EU 2024-519369-24-00
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-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 and have not yet received chemotherapy in the mCSPC setting.
Inclusion: 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: 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); Clinically significant cardiovascular disease; Known or suspected brain metastasis or active leptomeningeal disease; Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients; 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; Inadequate organ function.