Background Because the optimal timing of the institution ofantiandrogen therapy for prostate cancer is controversial, wecompared immediate and delayed treatment in patients who hadminimal residual disease after radical prostatectomy.
Methods Ninety-eight men who underwent radical prostatectomyand pelvic lymphadenectomy and who were found to have nodalmetastases were randomly assigned to receive immediate antiandrogentherapy, with either goserelin, a synthetic agonist of gonadotropin-releasinghormone, or bilateral orchiectomy, or to be followed until diseaseprogression. The patients were assessed quarterly during thefirst year and then semiannually.
Results After a median of 7.1 years of follow-up, 7 of 47 menwho received immediate antiandrogen treatment had died, as comparedwith 18 of 51 men in the observation group (P=0.02). The causeof death was prostate cancer in 3 men in the immediate-treatmentgroup and in 16 men in the observation group (P<0.01). Atthe time of the last follow-up, 36 men in the immediate-treatmentgroup (77 percent) and 9 men in the observation group (18 percent)were alive and had no evidence of recurrent disease, includingundetectable serum prostate-specific antigen levels (P<0.001).In the observation group, the disease recurred in 42 men; 13of the 36 who were treated had a complete response to localtreatment or hormonal therapy (or both), 16 died of prostatecancer, and 1 died of another disease. The remaining men inthis group were alive with progressive disease at the time ofthe last follow-up or had had a recent relapse. Except for thetreatment group (immediate therapy or observation), no clinicalor histologic characteristic significantly influenced the outcome.
Conclusions Immediate antiandrogen therapy after radical prostatectomyand pelvic lymphadenectomy improves survival and reduces therisk of recurrence in patients with node-positive prostate cancer.
Source Information
From the University of Rochester Medical Center, Rochester, N.Y. (E.M.M.); the Dana–Farber Cancer Institute, Boston (J.M.); the University of Texas, San Antonio (M.S.); the University of Wisconsin Comprehensive Cancer Center, Madison (G.W.); the University of Colorado Health Science Center, Denver (E.D.C.); and the University of Pittsburgh Cancer Institute, Pittsburgh (D.T.).
Address reprint requests to Dr. Messing at the University of Rochester, Department of Urology, 601 Elmwood Ave., Box 656, Rochester, NY 14642, or at edward_messing{at}urmc.rochester.edu.
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