IMPROVED SURVIVAL IN PATIENTS WITH LOCALLY ADVANCED PROSTATE-CANCER TREATED WITH RADIOTHERAPY AND GOSERELIN

Background We conducted a randomized, prospective trial comparing exte rnal irradiation with external irradiation plus goserelin (an agonist analogue of gonadotropin-releasing hormone that reduces testosterone s ecretion) in patients with locally advanced prostate cancer. Methods F rom 1987 to 1995, 415 patients with locally advanced prostate cancer w ere randomly assigned to receive radiotherapy alone or radiotherapy pl us immediate treatment with goserelin. The patients had a median age o f 71 years (range, 51 to 80). Patients in both groups received 50 Gy o f radiation to the pelvis over a period of five weeks and an additiona l 20 Gy over an additional two weeks as a prostatic boost. Patients in the combined-treatment group received 3.6 mg of goserelin (Zoladex) s ubcutaneously every four weeks starting on the first day of irradiatio n and continuing for three years; those patients also received cyprote rone acetate (150 mg orally per day) during the first month of treatme nt to inhibit the transient rise in testosterone associated with the a dministration of goserelin. Results Data were available for analysis o n 401 patients. The median follow-up was 45 months. Kaplan-Meier estim ates of overall survival at five years were 79 percent (95 percent con fidence interval, 72 to 86 percent) in the combined-treatment group an d 62 percent (95 percent confidence interval, 52 to 72 percent) in the radiotherapy group (P=0.001). The proportion of surviving patients wh o were free of disease at five years was 85 percent (95 percent confid ence interval, 78 to 92 percent) in the combined-treatment group and 4 8 percent (95 percent confidence interval, 38 to 58 percent) in the ra diotherapy group (P<0.001). Conclusions Adjuvant treatment with gosere lin, when started simultaneously with external irradiation, improves l ocal control and survival in patients with locally advanced prostate c ancer. (C) 1997, Massachusetts Medical Society.