A RANDOMIZED TRIAL (IRISH CLINICAL ONCOLOGY RESEARCH GROUP 97-01) COMPARING SHORT VERSUS PROTRACTED NEOADJUVANT HORMONAL THERAPY BEFORE RADIOTHERAPY FOR LOCALIZED PROSTATE CANCER

Purpose: To examine the long-term outcomes of a randomized trial comparing short (4 months; Arm 1) and long (8 months: Arm 2) neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. Methods and Materials: Between 1997 and 2001. 276 patients were enrolled and the data from 261 were analyzed. The stratification risk factors were prostate-specific antigen level >20 ng/ml. Gleason score >= 7, and Stage T3 or more. The intermediate-risk stratum had one factor and the high-risk stratum had two or more. Staging was done from the bone scan and computed tomography findings. The primary endpoint was biochemical failure-free survival. Results: The median follow-up was 102 months. The overall survival, biochemical failure-free survival, and prostate cancer-specific survival did not differ significantly between the two treatment arms, overall or at 5 years. The cumulative probability of overall survival at 5 years was 90% (range, 87-92%) in Arm 1 and 83% (range, 80-86%) in Arm 2. The biochemical failure-free survival rate at 5 years was 66% (range, 62-71%) in Arm 1 and 63% (range, 58-67%) in Arm 2. Conclusion: No statistically significant difference was found in biochemical failure-free survival between 4 months and 8 months or neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. (C) 2011 Elsevier Inc.