Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07028853 | This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. | PHASE3 | RECRUITING | 1,000 | — | — | Sep 28, 2025 | Dec 8, 2034 | Jun 5, 2026 | 331 | United States, Argentina +24 |
rPFS is defined as the time from randomization until PD based on BICR assessment per RECIST v1.1 (soft tissue disease) and PCWG3 (bone disease), or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Participants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily) |
| Arm B | ACTIVE_COMPARATOR | Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily) |
| Name | Type | Description |
|---|---|---|
| Mevrometostat | DRUG | Oral continuous |
| Placebo | DRUG | Oral continuous |
| Enzalutamide | DRUG | Oral continuous |
Inclusion Criteria * 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 s...