Phase 2 Study of Abiraterone 250 mg With Food Plus Prednisone Without LHRH Blockers For Hormonal Intensification in Men With Prostate Cancer

What this Trial Is About

This research aims to evaluate whether taking Abiraterone 250 mg with food plus prednisone, without using LHRH analogs or blockers ADT, can reduce testosterone levels to castration levels within 30 days in men with prostate cancer who require hormonal intensification. The study is a phase 2, open-label, multicenter trial focusing on patients with high-risk localized or metastatic hormone-sensitive prostate cancer, who have not yet started ADT. Participants will take Abiraterone 250 mg with food daily along with prednisone 5 to 10 mg per day starting on day 0. No LHRH analogs or blockers are given during the first 30 days. The study includes a screening period up to 7 days, followed by the 30-day treatment and evaluation period, with safety follow-up through day 60. Researchers will closely monitor participants for side effects and adjust treatment as needed. During the study, participants will undergo assessments including blood tests for testosterone, PSA, potassium, liver function, and safety evaluations at baseline and day 30. Blood pressure and adverse events will be monitored throughout. The main outcome is the proportion of patients achieving castration-level testosterone 50 ngdL at day 30 without ADT. Additional outcomes include changes in PSA levels and safety measures. Participants are followed for safety until day 60, with adherence supported by education and home blood pressure and symptom tracking.

Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)