Hermosillo

Researchers are studying a treatment approach for men with prostate cancer who need hormonal intensification. This Phase 2, open-label, multicenter trial focuses on using Abiraterone 250 mg taken with food plus prednisone, without the usual LHRH analogs or blockers (ADT), to see if it can lower testosterone to castration levels within 30 days in 80-90% of patients. The study includes patients at high or very high risk of recurrence or those with metastatic hormone-sensitive prostate cancer who are candidates for intensified hormonal therapy but have not yet started ADT. Participants receive Abiraterone 250 mg daily with food along with prednisone (5-10 mg/day). The treatment begins on Day 0, and patients are educated on how to take the medication correctly. No ADT is given during the first 30 days. The study includes a screening period up to 7 days before starting treatment, a primary endpoint evaluation around Day 30, and a safety follow-up until Day 60. This design allows assessment of testosterone suppression without ADT during the first month. During the study, researchers monitor patients through blood tests for testosterone, PSA, potassium, liver function, and other labs at screening and Day 30. Blood pressure, adverse events, and safety are also closely tracked. The main outcome measured is the proportion of patients achieving castration-level testosterone at Day 30. Additional assessments include PSA response and side effects. The study uses validated testosterone testing methods and encourages home monitoring of blood pressure and symptoms to ensure safety throughout participation.