Study on the Investigational Medicine PF-06821497 (Mevrometostat) for Men with Advanced Prostate Cancer Previously Treated with Abiraterone Acetate

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT06551324

This clinical trial is testing a new medicine, PF-06821497, combined with enzalutamide, to see if it is safe and effective for men with advanced prostate cancer that has spread and not responded to previous treatment with abiraterone acetate.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new medicine, PF-06821497, when used with enzalutamide, is safe and works well for treating men with advanced prostate cancer that has spread and is resistant to standard hormone therapy. The study will compare this combination to the usual treatment options, which include either enzalutamide alone or chemotherapy with docetaxel. The main goal is to see how long the cancer can be controlled without getting worse, as shown by imaging tests.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer that is not of the small cell type.
  • Cancer has spread to bones or soft tissues, as shown by scans.
  • Cancer is getting worse despite hormone therapy or surgery to lower testosterone levels.
  • Good overall health with an ECOG performance status of 0 to 2 and expected to live at least 6 more months.

Exclusion Criteria

  • Any serious medical or mental health condition, including recent or current thoughts of self-harm, that could make participation unsafe.
  • Significant heart disease.
  • Known or suspected cancer spread to the brain or spinal fluid, or a history of seizures.
  • Previous treatment for prostate cancer with certain chemotherapy drugs, hormone therapies, or other cancer treatments, except:
    • First-generation hormone treatments, if stopped before joining the study.
    • Docetaxel for prostate cancer that has not spread, as long as it was effective and the cancer did not worsen during or shortly after treatment.
  • Participation in another clinical trial within 30 days before starting this study.
  • Poor organ function.

Locations

FACILITYZIPCITYSTATE
Arizona Urology Specialists- Provide ICF for Review Only85715TucsonArizona
Arizona Urology Specialists (AUS)-Orange Grove85741TucsonArizona
Colorado Clinical Research80228LakewoodColorado
Duly Health and Care60521HinsdaleIllinois
Duly Health And Care60532LisleIllinois
NextStage Clinical Research-Chicago-(04)60532LisleIllinois
Duly Health and Care60559WestmontIllinois
AtlantiCare08234Egg Harbor TownshipNew Jersey
Salisbury VA Medical Center28144SalisburyNorth Carolina
Keystone Urology Specialists17604LancasterPennsylvania

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