Effect of Bicalutamide 150 Mg on PSA Progression in M0 Prostate Cancer: Results from the Early Prostate Cancer Program

4624 Background: Prostate-specific antigen (PSA) progression is the first sign of prostate cancer recurrence after primary therapy. In the Early Prostate Cancer (EPC) program, men with locally advanced disease who received bicalutamide 150 mg (CASODEX) in addition to standard care (radiotherapy [RT], radical prostatectomy [RP], or watchful waiting [WW]) had significantly improved objective progression-free survival (PFS) vs standard care alone. In the RT setting, this translated into improved overall survival (OS). Here, we compare PSA-PFS in the 3rd analysis of the EPC program with the results for objective PFS. METHODS The EPC program consists of 3 trials in which patients (all M0) with either localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N+) prostate cancer were randomized to receive standard care plus either bicalutamide 150 mg (n = 4052) or placebo (n = 4061). The primary end points were OS and objective PFS. PSA-PFS was a secondary end point. A PSA progression event was defined as PSA rising to ≥2× baseline or ≥0.4 ng/mL in men with non-quantifiable baseline PSA, death, or objective progression. PSA-PFS and objective PFS were analyzed for stage/therapy subgroups using a Cox proportional hazards model. RESULTS At 7.4 years' median follow-up, bicalutamide plus standard care was associated with significantly improved PSA-PFS vs placebo (p < 0.001), irrespective of primary therapy or disease stage. However, PSA-PFS benefit only translated into a significant objective PFS benefit in locally advanced disease ( table ). CONCLUSION Adding bicalutamide 150 mg to standard care significantly improves PSA-PFS for men with early, non-metastatic prostate cancer. The significant improvement in PSA-PFS was only accompanied by a significant improvement in objective PFS in locally advanced disease. Consequently, a significant PSA-PFS benefit cannot always be assumed to translate into a significant objective PFS benefit. [Table: see text] [Table: see text].