MAXIMAL ANDROGEN BLOCKADE - FINAL ANALYSIS OF EORTC PHASE-III TRIAL-30853

Objectives: This prospective, randomized phase III study was initiated to compare the efficacy and side effects of bilateral orchiectomy ver sus a combination of a luteinizing hormone-releasing hormone agonist d epot formulation, goserelin acetate (3.6 mg s.c., once every 4 weeks) and flutamide (250 mg 3 x daily) in patients with metastatic prostate cancer. Methods: Relative treatment efficacy was assessed by comparing the two treatment groups with respect to response, time to first prog ression, progression-free survival, duration of survival and time to d eath due to malignant disease. Results: There was a difference in resp onse only with respect to a more frequent decrease to normal of the se rum prostate acid phosphatase in patients assigned to maximal androgen blockade treatment. Additionally, maximal androgen blockade treatment showed significantly better results for duration of survival (p = 0.0 4), time to death due to malignant disease (p = 0.008), time to first progression (p = 0.009) and progression-free survival (p = 0.02), The most frequent side effects for both treatments included hot flushes an d gynaecomastia, Conclusions: Increased time to progression and durati on of survival is achieved by the combination of flutamide and goserel in when compared to bilateral orchiectomy.