What is the Purpose of this Study?
This study focuses on people who have metastatic castration-sensitive prostate cancer (mCSPC) and have not received treatment with novel hormonal therapy or chemotherapy in the mCSPC setting. The purpose of the study is to learn more about the safety and effects of an experimental drug called mevrometostat (PF-06821497) when given with another drug called enzalutamide. Mevrometostat is designed to inhibit a specific protein; enzalutamide is a standard-of-care treatment that is approved by the U.S. Food and Drug Administration (FDA) to treat mCSPC. This study will explore whether a combination of mevrometostat and enzalutamide will work better than taking enzalutamide alone. Participants will be randomly assigned to receive either mevrometostat and enzalutamide, or a placebo (inactive substance) and enzalutamide. Study procedures also include health questionnaires, imaging, electrocardiogram, and biopsy.
Eligibility
- * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
- * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
- * Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
- * Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
Where can I participate?
- CS Cancer at Beverly Hills : Maria Tarallo
- CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo
More about this Clinical Trial
What is the full name of this clinical trial?
C2321008: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat with Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer