ANDROGEN SUPPRESSION PLUS RADIATION VERSUS RADIATION ALONE FOR PATIENTS WITH D1 (PN-85-31)() ADENOCARCINOMA OF THE PROSTATE (RESULTS BASED ON A NATIONAL PROSPECTIVE RANDOMIZED TRIAL, RTOG)

Purpose: To evaluate the effect of immediate androgen suppression in c onjunction with standard external beam irradiation vs, radiation alone on a group of pathologically staged lymph node-positive patients with adenocarcinoma of the prostate, Methods and Materials: A national pro spective randomized trial (RTOG 85-31) of standard external beam irrad iation plus immediate androgen suppression vs, external beam irradiati on alone was initiated in 1985 for patients with locally advanced aden ocarcinoma of the prostate, One hundred seventy-three of the patients in this trial had biopsy-proven pathologically involved lymph nodes, N inety-eight of these patients received radiation plus the immediate an drogen suppression (LHRH agonist), while 75 received radiation alone w ith hormonal manipulation instituted at the time of relapse, Results: With a median followup of 4.9 years, estimated progression-free surviv al with PSA < 1.5 ng/ml at 5 years was 55% for the patients who receiv ed radiation plus immediate LHRH agonist vs, 11% of the patients who r eceived radiation alone with hormonal manipulation at relapse (p = 0.0 001), Because all of these patients had locally advanced disease (i.e. , pathologically positive lymph nodes), stage does not explain this di fference in outcome, and Gleason grade was not statistically different between the two groups, Estimated absolute survival at 5 years for th e radiation and LHRH group was 73 vs, 65% for the radiation alone grou p who received androgen suppression at relapse, Estimated disease-spec ific survival at 5 years was 82% for the radiation and immediate LHRH agonist group and 77% for the radiation-alone group, Conclusion: Patie nts with adenocarcinoma of the prostate and pathologically involved pe lvic lymph nodes (pN+ or clinical stage D1) should be seriously consid ered for external beam irradiation plus immediate hormonal manipulatio n over radiation alone with hormonal manipulation at the time of relap se. (C) 1997 Elsevier Science Inc.