A randomized trial comparing radical prostatectomy with watchful
waiting in early prostate cancer.
Holmberg
L, Bill-Axelson A, Helgesen
F, Salo JO, Folmerz P, Haggman M, Andersson SO, Spangberg A, Busch C, Nordling S,
Palmgren J, Adami HO,
Johansson JE, Norlen BJ; Scandinavian Prostatic
Cancer Group Study Number 4.
Regional Oncologic Center,
BACKGROUND: Radical prostatectomy is
widely used in the treatment of early prostate cancer. The possible survival
benefit of this treatment, however, is unclear. We conducted a randomized trial
to address this question.
METHODS: From October 1989 through
February 1999, 695 men with newly diagnosed prostate cancer in International
Union against Cancer clinical stage T1b, T1c, or T2 were randomly assigned to
watchful waiting or radical prostatectomy. We achieved complete follow-up through the year 2000 with blinded evaluation of causes
of death. The primary end point was death due to prostate cancer, and the
secondary end points were overall mortality, metastasis-free survival, and
local progression.
RESULTS: During a median of 6.2
years of follow-up, 62 men in the watchful-waiting group and 53 in the
radical-prostatectomy group died (P=0.31). Death due to prostate cancer
occurred in 31 of 348 of those assigned to watchful waiting (8.9 percent) and
in 16 of 347 of those assigned to radical prostatectomy (4.6 percent) (relative
hazard, 0.50; 95 percent confidence interval, 0.27 to 0.91; P=0.02). Death due
to other causes occurred in 31 of 348 men in the watchful-waiting group (8.9
percent) and in 37 of 347 men in the radical-prostatectomy group (10.6
percent). The men assigned to surgery had a lower relative risk of distant
metastases than the men assigned to watchful waiting (relative hazard, 0.63; 95
percent confidence interval, 0.41 to 0.96).
CONCLUSIONS: In this randomized trial,
radical prostatectomy significantly reduced disease-specific mortality, but
there was no significant difference between surgery and watchful waiting in
terms of overall survival.
Copyright
2002 Massachusetts Medical Society
Publication
Types:
Clinical
Trial
Multicenter Study
Randomized
Controlled Trial
PMID:
12226148 [PubMed - indexed for MEDLINE]