Immediate Hormonal Therapy vs Observation in Node-Positive Prostate Cancer

Immediate antiandrogen therapy after radical prostatectomy and pelvic lymphadenectomy improves survival and reduces the risk of recurrence in patients with node-positive prostate cancer, according to a study published in the December 9, 1999, issue of The New England Journal of Medicine. The optimal time to initiate treatment remains unresolved in advanced prostate cancer; however, current clinical practice often involves waiting for recurrence before further treatment is initiated. This trial, conducted by the Eastern Cooperative Oncology Group, compared immediate vs delayed treatment in patients with minimal residual disease.

The trial enrolled 98 men who were found to have nodal metastases after radical prostatectomy and pelvic lymphadenectomy. The men were randomized to receive immediate antiandrogen therapy with either goserelin (Zoladex) or bilateral orchiectomy or to be followed until disease progressed.

Study Results

After a median of 7.1 years of follow-up, 7 of 47 men in the immediate antiandrogen group had died, as compared with 18 of 51 in the observation group (P = .02). At last follow-up, 36 men in the immediate-therapy group (77%) and 9 men in the observation group (18%) were alive and had no evidence of recurrent disease.

Investigators concluded that immediate antiandrogen therapy after radical prostatectomy and pelvic lymphadenectomy improves survival and reduces the risk of recurrence in patients with node-positive prostate cancer. However, although these results suggest an advantage for early androgen deprivation therapy, further trials are needed to confirm these findings.

This trial was supported, in part, by Public Health Service grants from the National Cancer Society, the National Institutes of Health, and the Department of Health and Human Services. Investigators included Edward M. Messing, MD, the University of Rochester Medical Center (lead investigator); Judith Manola, MS, Dana-Farber Cancer Institute; Michael Sarosdy, MD, the University of Texas; George Wilding, MD, University of Wisconsin Comprehensive Cancer Center; E. David Crawford, MD, University of Colorado Health Sciences Center; and Donald Trump, MD, University of Pittsburgh Cancer Institute.