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
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.