ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with
enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior
abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3
criteria prior to study entry.
The patient population will be separated into two cohorts:
Cohort A: Patients with poor response to prior abiraterone defined as:
- Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: < 12
months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking
abiraterone, or;
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6
months duration on abiraterone or failure to achieve PSA50 response while on abiraterone
Cohort B: Patients with response to prior abiraterone, defined as:
- Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12
months duration on abiraterone and nadir PSA < 0.2 ng/mL, or;
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6
months duration on abiraterone and confirmed PSA50 response