A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer
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.
About the Study Medicine & Design
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.
This study is intended for patients 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.
Screening Phase
Initial medical scans, blood work, and health history evaluations to confirm candidate alignment with safety specifications.
1:1 Randomization
Participants are assigned to receive either Arm A (PF-06821497 + enzalutamide) or Arm B (placebo + enzalutamide).
Treatment & Follow-up
Regular clinical visits, safety monitoring, and long-term follow-up assessments with the principal investigator team.
Understanding Your Participation
Watch this short overview to learn how clinical trials work, what to expect during clinic visits, and the science behind the investigational study medicine.
A Study to Learn How PF-06821497 Works in Men With Metastatic Castration-resistant Prostate Cancer
This multinational clinical trial evaluates the efficacy of the investigational combination of PF-06821497 and enzalutamide compared to standard enzalutamide therapy in participants with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received systemic hormone therapies for advanced disease.
Who May Participate
Review our primary criteria guidelines below to understand the clinical requirements for this research program.
Inclusion Criteria
Primary requirements to be met:- Histologically or cytologically confirmed adenocarcinoma of the prostate (without small cell features).
- Documented metastatic disease present in the bone (via bone scan) or soft tissue (via CT/MRI scan).
- Evidence of progressive disease in the setting of ongoing medical or surgical castration.
- ECOG performance status of 0 or 1, with an estimated life expectancy of 12 months or longer.
Exclusion Criteria
Conditions that prevent participation:- Active inflammatory gastrointestinal disease, chronic diarrhea, gastric resection, or history of lap-band surgery.
- Clinically significant cardiovascular disease, active seizure history, or known/suspected brain metastasis.
- History of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or other major active malignancies.
- Prior systemic anti-cancer treatments at the mCRPC stage (participants must be treatment naïve at this stage, with minor exceptions).
- Administration of any other investigational drug or vaccine within 30 days prior to randomization.
Not sure if you qualify?
Take our secure, 2-minute screening assessment to check your potential eligibility for this study.
Clinical trial details are registered under Identifier NCT06821497. The clinical criteria outlined above represent a subset of the comprehensive medical evaluation required for trial entry. Eligibility determinations are made solely by qualified clinical trial physicians at official research institutions. Consultation with your personal physician is recommended prior to enrollment.
Trial Benefits & Participant Support
Understanding your resources, care provisions, and safety safeguards during the PF-06821497 Phase 3 clinical study for metastatic castration-resistant prostate cancer (mCRPC).
Investigational Treatment
All study-related medications, including the investigational drug PF-06821497 (mevrometostat) and enzalutamide, are provided at no cost to participants.
Comprehensive Monitoring
Receive regular clinical health assessments, PSA monitoring, imaging scans, and laboratory tests to closely manage your health status.
Specialist Care Access
Direct, ongoing access to leading prostate cancer oncologists and a dedicated clinical research team throughout your participation.
Travel & Expense Support
Reimbursement is provided for reasonable study-related travel expenses, parking, lodging, and meals associated with scheduled clinical site visits.
Advance Cancer Science
Your participation contributes vital clinical data to help advance next-generation therapeutic options for men facing advanced prostate cancer.
Rigorous Safety Protection
The study is fully overseen by Institutional Review Boards (IRB) and independent data monitoring committees to guarantee patient rights and safety.
Frequently Asked Questions
Find clear, transparent information about participating in our Phase 3 clinical study for metastatic castration-resistant prostate cancer (mCRPC).
What is a clinical trial and is it safe?
A clinical trial is a carefully controlled scientific study designed to evaluate the safety and effectiveness of an investigational medical treatment. Patient safety is our highest priority. This Phase 3 trial is strictly regulated by the US Food and Drug Administration (FDA) and is monitored closely by an independent Institutional Review Board (IRB) and Data Safety Monitoring Board (DSMB) to ensure all ethical and safety standards are maintained.
How long will I be in the study?
Your participation timeline depends on how your body responds to the treatment. The study consists of a Screening Phase (up to 30 days), a Treatment Phase, a Safety Follow-up Phase (approximately 30 days after your last dose), and a Long-Term Follow-up Phase. The study doctor will discuss the exact anticipated duration based on your medical profile.
What are the possible risks and side effects?
As with any investigational drug, there may be side effects. The combination of PF-06821497 (mevrometostat) and enzalutamide is being studied to understand both its benefits and potential risks. Before you decide to participate, the study team will provide you with an Informed Consent Form (ICF) that details all known potential side effects, risks, and safety measures in comprehensive medical and plain language.
Will my information be kept confidential?
Yes, absolutely. Your personal health information is protected under strict federal regulations, including HIPAA in the United States. All data collected during the study is de-identified, meaning your name and personal details are replaced with a unique participant code. Only authorized clinical staff will have access to your records.
Can I leave the study if I change my mind?
Yes. Your participation in this clinical trial is entirely voluntary. You have the legal right to withdraw from the study at any time, for any reason, without explanation, and without any penalty or loss of benefits to which you are otherwise entitled. Your standard medical care will not be affected.
Will I receive the actual medication or a placebo?
This is a randomized, double-blind study. Participants are assigned on a 1:1 basis to one of two groups: Arm A receives the investigational drug PF-06821497 combined with enzalutamide, while Arm B receives a placebo combined with enzalutamide. Neither you nor your study doctor will know which arm you are assigned to during the trial, though this information can be quickly unblinded in an emergency.
What happens after the study ends?
Once the study treatment period is complete, you will undergo a comprehensive health assessment. You will transition back to your primary oncologist for standard-of-care treatments. Pfizer will analyze the study findings to help advance prostate cancer research, and the aggregated results will be published on clinicaltrials.gov.