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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06136624 | Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) | PHASE3 | RECRUITING | 1,310 | — | — | Dec 31, 2023 | Feb 15, 2030 | May 5, 2026 | 282 | United States, Argentina +34 |
OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-positive participants will be reported for each study arm.
OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-negative participants will be reported for each study arm.
| Arm | Type | Description |
|---|---|---|
| Opevesostat | EXPERIMENTAL | Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) dose will also be provided to participants for use as rescue medication. |
| Abiraterone Acetate or Enzalutamide | ACTIVE_COMPARATOR | Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets. |
| Name | Type | Description |
|---|---|---|
| Opevesostat | DRUG | Administered orally |
| Abiraterone acetate | DRUG | Administered orally |
| Enzalutamide | DRUG | Administered orally |
| Hydrocortisone | DRUG | Administered orally or IM as a rescue medication |
| Fludrocortisone acetate | DRUG | Administered orally |
| Prednisone | DRUG | Administered orally |
| Dexamethasone | DRUG | Administered orally as rescue medication |
Inclusion Criteria: * Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology. * Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening * Has current evidence of distan...