Study on How PF-06821497 (Mevrometostat) Works in Men with Advanced Prostate Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT06629779
This clinical trial is testing whether a new drug, PF-06821497, combined with enzalutamide, is more effective than enzalutamide alone in treating men with advanced prostate cancer that has spread and is resistant to standard hormone therapy.
Patient Parameters
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Program Overview
The study aims to find out if the combination of the investigational drug PF-06821497 and enzalutamide can better treat men with metastatic castration-resistant prostate cancer (mCRPC) compared to enzalutamide alone. Participants in this study have not received certain previous treatments for their cancer, except for hormone therapy and some first-generation anti-androgen drugs.
Description
This is a large, international study where participants are randomly assigned to one of two groups. One group will receive the new drug PF-06821497 along with enzalutamide, while the other group will receive a placebo with enzalutamide. The study includes several phases: screening, randomization, treatment, safety follow-up, and long-term follow-up. Participants must not have received certain previous treatments for their cancer, except for hormone therapy and some first-generation anti-androgen drugs. The study will help determine if the new combination treatment is more effective in managing advanced prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older.
- Diagnosed with prostate cancer that has spread to bones or soft tissue.
- Cancer must be resistant to standard hormone therapy.
- Must have low testosterone levels due to medical or surgical treatment.
- Must have a good overall health status and a life expectancy of at least 12 months.
Exclusion Criteria
- Any serious medical or mental health condition that could increase risks or interfere with the study.
- Significant heart disease.
- Cancer that has spread to the brain or spinal fluid.
- Previous treatment with certain cancer drugs, except for specific hormone therapies.
- Recent participation in another drug trial.
- Use of certain medications that could interfere with the study drugs.
- Recent major surgery or radiation therapy.
- Poor organ function.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Arizona Urology Specialists (East Side Location) | 85715 | Tucson | Arizona |
| Arizona Urology Specialists (AUS)-Orange Grove | 85741 | Tucson | Arizona |
| Highlands Oncology | 72703 | Fayetteville | Arkansas |
| Highlands Oncology | 72758 | Rogers | Arkansas |
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Duly Health and Care (Bone Scintigraphy) | 60532 | Lisle | Illinois |
| NextStage Clinical Research-Chicago-(04) | 60532 | Lisle | Illinois |
| Duly Health and Care (CT and MRI) | 60559 | Westmont | Illinois |
| Adult & Pediatric Urology, PC | 68114 | Omaha | Nebraska |
| AUC Urologists, LLC | 29572 | Myrtle Beach | South Carolina |
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