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Looking for participantsPhase3

A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

Sponsor: Pfizer

NCT ID: NCT06629779

View on ClinicalTrials.gov ↗

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.

Metastatic Castration-Resistant Prostate Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic 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 life expectancy of ≥12 months as assessed by the investigator. Exclusion Criteria: * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study. * Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery. * 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 malignancy with a few exceptions. * Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions: 1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate; 2. 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. * Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer). * Inadequate organ function.

Where Is This Study? (5 UK sites)

Royal Blackburn Hospital

Blackburn BB2 3HH, United Kingdom

Recruiting

Mid and South Essex NHS Foundation Trust

Chelmsford CM1 7ET, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Sam Hayton

mse.researchenquiries@nhs.net---

Royal Derby Hospital

Derby DE22 3NE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Teresa Grieve

uhdb.researchgov@nhs.net01332 724639 / 01332 724638

The Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08