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
- PF-06821497 (drug), Placebo (drug), Enzalutamide (drug)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- PF-06821497 — 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
- 900
- Started
- 2024-10-22
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic castration-resistant prostate cancer
- • Phase3 - 900 participants
- • This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic castration-resistant prostate cancer
- • Male only
Where?
- • Blackburn - Royal Blackburn Hospital
- • Chelmsford - Mid and South Essex NHS Foundation Trust
- • Derby - Royal Derby Hospital
- • Glasgow - The Beatson West of Scotland Cancer Centre
- • +1 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 PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
More detail
This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting. 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) 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
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓confirmed by testing a sample adenocarcinoma of the prostate without small cell features.
- ✓that has spread 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 expected to live at least 12 $2 as assessed by the investigator.
Who cannot take part
- ✗Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or...
- ✗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 cancer with a few exceptions.
- ✗Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
See the full criteria
Where Is This Study? (5 UK sites)
Royal Blackburn Hospital
Blackburn BB2 3HH, United Kingdom
Mid and South Essex NHS Foundation Trust
Chelmsford CM1 7ET, United Kingdom
Royal Derby Hospital
Derby DE22 3NE, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
Sponsor contactCONTACT
