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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06312670 | Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer | PHASE2 | COMPLETED | 13 | — | — | May 16, 2024 | Jan 9, 2025 | May 29, 2025 | 2 | United States |
Defined as prostate-specific antigen (PSA) undetectable (\<0.2 ng/mL) at 6 months after treatment. The true BRR for the study population will be estimated based on the number of biochemical responses using a binomial distribution, and its confidence interval (CI) will be estimated using Wilson's method.
Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed
Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed
Objective response rate (ORR)
| Arm | Type | Description |
|---|---|---|
| EPI-7386 + Enzalutamide | EXPERIMENTAL | EPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles). |
| Name | Type | Description |
|---|---|---|
| EPI-7386 | DRUG | 600 mg orally administered twice daily |
| Enzalutamide | DRUG | 160 mg administered orally once daily, with or without food |
| Androgen Deprivation Therapy (ADT) | DRUG | LHRH agonist/antagonist or orchiectomy |
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed prostate adenocarcinoma without small cell or neuroendocrine features (please note: \>10% small cell or neuroendocrine differentiation will be excluded). * Subjects must have received no prior second-generation antia...