Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer

Background: Because the optimal timing of the institution of antiandrogen t herapy for prostate cancer is controversial, we compared immediate and dela yed treatment in patients who had minimal residual disease after radical pr ostatectomy. Methods: Ninety-eight men who underwent radical prostatectomy and pelvic ly mphadenectomy and who were found to have nodal metastases were randomly ass igned to receive immediate antiandrogen therapy, with either goserelin, a s ynthetic agonist of gonadotropin-releasing hormone, or bilateral orchiectom y, or to be followed until disease progression. The patients were assessed quarterly during the first year and then semiannually. Results: After a median of 7.1 years of follow-up, 7 of 47 men who received immediate antiandrogen treatment had died, as compared with 18 of 51 men i n the observation group (P = 0.02). The cause of death was prostate cancer in 3 men in the immediate-treatment group and in 16 men in the observation group (P<0.01). At the time of the last follow-up, 36 men in the immediate- treatment group (77 percent) and 9 men in the observation group (18 percent ) were alive and had no evidence of recurrent disease, including undetectab le serum prostate-specific antigen levels (P<0.001). In the observation gro up, the disease recurred in 42 men; 13 of the 36 who were treated had a com plete response to local treatment or hormonal therapy (or both), 16 died of prostate cancer, and 1 died of another disease. The remaining men in this group were alive with progressive disease at the time of the last follow-up or had had a recent relapse. Except for the treatment group (immediate the rapy or observation), no clinical or histologic characteristic significantl y influenced the outcome. Conclusions: Immediate antiandrogen therapy after radical prostatectomy and pelvic lymphadenectomy improves survival and reduces the risk of recurrenc e in patients with node-positive prostate cancer. (N Engl J Med 1999;341:17 81-8.) (C)1999, Massachusetts Medical Society.