Is There a Standard of Care for Pathologic Stage T3 Prostate Cancer?

As many as one third of patients undergoing radical prostatec-tomy will be found to have pathologic stage T3 (pT3) prostate cancer (PCA) with positive margins, extraprostatic extension, or involve-ment of the seminal vesicles.1 A debate has raged for decades over the utility of adjuvant radiotherapy in treating these men. Case studies have argued for and against this treatment without the establishment of a clear standard of care. Three randomized clinical trials have provided initial data from more than 1,800 patients with similar outcomes. The first of these studies, S8794,2 was initiated in 1987 and conducted by the Southwest OncologyGroup(SWOG). In this study, 425menwithpT3PCAwere randomly assigned toobservationor adjuvant radiotherapywith 60 to 64Gywithin4monthsof surgery. In2006,with amedian follow-upof 10.6 years, the first report of results of this study described a highly significant reduction in biochemical failure rate (median prostate-specific antigen [PSA] relapse-free interval, 10.3 years for radiother-apy v 3.1 years for observation; hazard ratio [HR], 0.43; 95%CI, 0.31 to 0.58;P .001), but the study fell just short of achieving significance for the primary end point of metastasis-free survival (median metastasis-free estimate, 14.7 years for radiotherapy v 13.2 years for observation; HR, 0.75; 95%CI, 0.55 to 1.02; P .06). Notable as well was a significant reduction in requirement for hormonal therapy in those receiving radiation. The second study,3 initiated in 1992 by the European Organisation for Research and Treatment of Cancer (EORTC), included 1,005 patients with a design similar to that of the SWOG study.2 Its first report with 5-yearmedian follow-up indicated significant improvement in biochemical failure (74.0 % [95 % CI, 68.7 % to 79.3%] v 52.6 % [95%CI, 46.6 % to 58.5%]; P .0001). In this issue of Journal of Clinical Oncology (JCO),Wiegel et al4 report the results of a third randomized trial of adjuvant radiother-apy for pT3 PCA by the Working Group on Radiation Oncology