At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Mevrometostat (drug), Placebo (drug), Enzalutamide (drug)
- How long the study runs
- Study runs about 111 months (dates as stated)
- About the drug or intervention
- Mevrometostat — drug: Oral continuous · Placebo — drug: Oral continuous · Enzalutamide — drug: Oral continuous
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 1,000
- Started
- 2025-09-28
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic castration sensitive prostate cancer (mcspc)
- • Phase3 - 1,000 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic castration sensitive prostate cancer (mcspc)
- • Male only
Where?
- • Blackburn - Royal Blackburn Hospital
- • Cardiff - Velindre Cancer Centre
- • Plymouth - Derriford Hospital
- • Torquay - Torbay Hospital
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ to either baseline severity
- ✓ ECOG PS 0 or 1
What the study is looking for
- ✓Inclusion Criteria
- ✓Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
- ✓confirmed by testing a sample adenocarcinoma of the prostate without small cell features.
- ✓that has spread prostate cancer documented by positive bone scan (for bone disease) or that has spread lesion(s) on CT or MRI...
- ✓Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which...
See the full criteria
Where Is This Study? (8 UK sites)
Royal Blackburn Hospital
Blackburn BB2 3HH, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Derriford Hospital
Plymouth Pl6 8DH, United Kingdom
Torbay Hospital
Torquay TQ2 7AA, United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London W6 8RF, United Kingdom
Royal Marsden Hospital (Chelsea)
London SW3 6JJ, United Kingdom
Maidstone Hospital
Maidstone ME16 9QQ, United Kingdom
Denise Day / Julie Knowles
mtw-tr.researchgovernance@nhs.net01622 225627The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT
