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Previous Volume 347:781-789 September 12, 2002 Number 11 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Walsh, P. C. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

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.

Source Information

From the Regional Oncologic Center (L.H.) and the Department of Urology (A.B.-A., M.H., B.J.N.), University Hospital, Uppsala, Sweden; the Center for Assessment of Medical Technology (F.H., J.-E.J.) and the Department of Urology (S.-O.A., J.-E.J.), Örebro University Hospital, Örebro, Sweden; the Department of Urology, Helsinki University Hospital, Helsinki, Finland (J.O.S.); the Department of Urology, Borås Hospital, Borås, Sweden (P.F.); the Department of Urology, University Hospital, Linköping, Sweden (A.S.); the Department of Pathology, University Hospital, Tromsö, Norway (C.B.); the Department of Pathology, Haartman Institute, University of Helsinki, Helsinki, Finland (S.N.); the Department of Medical Epidemiology, Karolinska Institute, Stockholm, Sweden (J.P., H.-O.A.); and the Department of Epidemiology and the Harvard Center for Cancer Prevention, Harvard School of Public Health, Boston (H.-O.A.).

Drs. Johansson and Norlén contributed equally to the article.

Address reprint requests to Dr. Bill-Axelson at the Department of Urology, University Hospital, SE-751 85 Uppsala, Sweden, or at anna.bill-axelson{at}urologi.uas.lul.se.

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