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ABSTRACT

Background In 2002, we reported the initial results of a trial comparing radical prostatectomy with watchful waiting in the management of early prostate cancer. After three more years of follow-up, we report estimated 10-year results.

Methods From October 1989 through February 1999, 695 men with early prostate cancer (mean age, 64.7 years) were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men). The follow-up was complete through 2003, with blinded evaluation of the causes of death. The primary end point was death due to prostate cancer; the secondary end points were death from any cause, metastasis, and local progression.

Results During a median of 8.2 years of follow-up, 83 men in the surgery group and 106 men in the watchful-waiting group died (P=0.04). In 30 of the 347 men assigned to surgery (8.6 percent) and 50 of the 348 men assigned to watchful waiting (14.4 percent), death was due to prostate cancer. The difference in the cumulative incidence of death due to prostate cancer increased from 2.0 percentage points after 5 years to 5.3 percentage points after 10 years, for a relative risk of 0.56 (95 percent confidence interval, 0.36 to 0.88; P=0.01 by Gray's test). For distant metastasis, the corresponding increase was from 1.7 to 10.2 percentage points, for a relative risk in the surgery group of 0.60 (95 percent confidence interval, 0.42 to 0.86; P=0.004 by Gray's test), and for local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk of 0.33 (95 percent confidence interval, 0.25 to 0.44; P<0.001 by Gray's test).

Conclusions Radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastasis and local progression. The absolute reduction in the risk of death after 10 years is small, but the reductions in the risks of metastasis and local tumor progression are substantial.

Source Information

From the Department of Urology (A.B.-A., M.H., B.J.N.), the Regional Oncologic Center (L.H., H.G.), and the Department of Pathology (C.B.), University Hospital, Uppsala, Sweden; the Departments of Urology (M.R.) and Pathology (S.N.), University of Helsinki and University Hospital of Helsinki, Helsinki; the Department of Urology (S.-O.A., J.-E.J.) and the Center for Assessment of Medical Technology (J.-E.J.), Örebro University Hospital, Örebro, Sweden; the Department of Urology, Borås Hospital, Borås, Sweden (S.B.); the Department of Urology, Linköping University Hospital, Linköping, Sweden (A.S.); the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm (J.P., H.-O.A.); and the Department of Epidemiology, Harvard School of Public Health, Boston (H.-O.A.).

Drs. Bill-Axelson and Holmberg 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}akademiska.se.

Full Text of this Article

Related Letters:

Radical Prostatectomy versus Watchful Waiting
Stuart M. E., Strite S. A., Marantz P. R., Hall C. B., Derby C. A., Liss H. K., Elmore J. G., Sonpavde G., Bill-Axelson A., Holmberg L., Johansson J.-E.
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N Engl J Med 2005; 353:1298-1300, Sep 22, 2005. Correspondence

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