Adjuvant radiotherapy versus observation alone, after radical prostatectomy in high risk prostate cancer.

OBJECTIVES the authors compared biochemical and clinical outcomes of patients with resected high-risk prostate cancer, managed with adjuvant radiotherapy or observation alone. METHODS patients treated with radical prostatectomy (RP) between January 1995 and December 2005 at the authors' department were evaluated. Patients with pT3, with or without positive surgical margins (PSM), were included for analysis. Demographic, clinical, pathologic and follow-up data were recorded. Comparison was made between adjuvant radiotherapy group (AR) and observation alone group (OA). Primary end-point was biochemical progression-free survival. RESULTS out of 739 patients treated with RP, 49 presented with pT3 with or without PSM. 39 received adjuvant radiotherapy and 10 were observed. Median follow- up was 6.2 years for AR and 7.3 years for OA. Biochemical progression occurred in 12.8%, in AR, and 70%, in OA (p=0.0008). Five-year biochemical progression-free survival was 87.1% in AR and 30% in OA (HR 0.12, 95% CI 0.03- 0.48 - p<0.0001). Rescue androgen deprivation therapy was needed in 2.6%, in AR, and 30%, in OA (p=0.023). CONCLUSIONS adjuvant radiotherapy after radical prostatectomy in high-risk prostate cancer provided better biochemical outcomes. Whether this translates into better clinical progression, it is still unknown.