Is There a Role for Pelvic Irradiation in Localized Prostate Adenocarcinoma: Final Results of the European Groupe d'Etude des Tumeurs Uro-Génitales (GETUG-01) Randomized Study

Abstract

Purpose/Objective(s): To report the final results of the GETUG-01 study in terms of progression-free survival (PFS) and overall survival (OS). Materials/Methods: Between December 1998 and June 2004, 446 patients with T1beT3, N0 pNx, M0 prostate carcinoma were randomly assigned to either pelvic or prostate (pelvic) or prostate only (PO) radiation therapy. Patients were stratified according to the prognostic factor of lymph node involvement (LNI): low risk (LR) (T1-T2 T1-2 and GS = 6 and PSA <3x the upper normal limit of the laboratory) (92 patients) versus high risk (HR) (T3 or GS>6 or PSA >3x the upper normal limit of the laboratory). Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for HR patients. Radiation therapy was delivered with a 3-dimensional conformal technique, using a 4-field technique for the pelvic volume (46 Gy). The total dose recommended to the prostate moved from 66 Gy to 70 Gy during the course of the study. Criteria for PFS included biologic prostate-specific antigen recurrences or a local or metastatic evolution. Results: Update of survival data was done in 2014. With a median follow-up of 11.4 years, the 10-year OS and PFS did not differ between the two treatment arms: 74.9% versus 73.6% and 55% versus 51% for the pelvic and PO arms, respectively. PFS results depending on prognostic factor did not show any significant difference between arms in HR patients (10-year PFS: 48.5% vs. 49.5%), but even if not significant, a trend was observed in the LR subgroup in favor of the pelvic arm (76.6% vs 59.8%; P = .15). On multivariate analysis, LNI risk and hormonal therapy were significantly associated with increased PFS. Conclusion: Pelvic node irradiation did not statistically improve PFS or OS.