Goserelin acetate with or without antiandrogen or estrogen in the treatment of patients with advanced prostate cancer: a multicenter, randomized, controlled trial in Japan

Objective: The aims of this randomized, controlled study were to Investigat e the efficacy and safety of long-term monotherapy with the luteinizing hor mone-releasing hormone agonist goserelin acetate compared with bath short- and long-term combined androgen blockade. Methods: Patients with advanced prostate cancer (n = 371) were randomized t o treatment with goserelin acetate alone or a combination of goserelin acet ate plus either long-term or short-term antiandrogen (chlormadinone acetate ) or short-term estrogen (diethylstilbestrol diphosphate), Results: There were no significant differences between the treatment groups with respect to objective progression, overall survival or disease-specifi c survival. Nevertheless, subgroup analysis suggested that patients with mi nimal disease or a good prognosis might benefit more from combined androgen blockade than other patients. Combined androgen blockade significantly red uced the incidence of disease flare compared with goserelin acetate treatme nt alone. Conclusions: Neither short- nor long-term combined androgen blockade had a survival advantage over goserelin acetate alone.