Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated (by chance) to one of two treatment arms.
In the Experimental Arm, participants will receive PF-06821497 twice daily plus enzalutamide hormone therapy daily.
In the Active Comparator Arm, participants will receive Physician's choice of either enzalutamide hormone therapy daily or docetaxel chemotherapy intravenously every 3 weeks.
Conditions
This trial is treating people with metastatic castration resistant prostate cancer without small cell features who have been previously treated with abiraterone acetate
Eligibility
Inclusion
- 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 surgical or medical castration.
- Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
Exclusion
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant. inappropriate for the study.
- Clinically significant cardiovascular disease.
- Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
-
Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy, 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:
- Treatment with first-generation antiandrogen agents, if discontinued prior to randomization
- 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 within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is shorter).
- Inadequate organ function.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You are currently being treated on a clinical trial.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
Pfizer
Scientific Title
A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)
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