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Original Article
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Volume 360:1320-1328 March 26, 2009 Number 13
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Screening and Prostate-Cancer Mortality in a Randomized European Study
Fritz H. Schröder, M.D., Jonas Hugosson, M.D., Monique J. Roobol, Ph.D., Teuvo L.J. Tammela, M.D., Stefano Ciatto, M.D., Vera Nelen, M.D., Maciej Kwiatkowski, M.D., Marcos Lujan, M.D., Hans Lilja, M.D., Marco Zappa, Ph.D., Louis J. Denis, M.D., Franz Recker, M.D., Antonio Berenguer, M.D., Liisa Määttänen, Ph.D., Chris H. Bangma, M.D., Gunnar Aus, M.D., Arnauld Villers, M.D., Xavier Rebillard, M.D., Theodorus van der Kwast, M.D., Bert G. Blijenberg, Ph.D., Sue M. Moss, Ph.D., Harry J. de Koning, M.D., Anssi Auvinen, M.D., for the ERSPC Investigators

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Editor's note: Do the benefits of PSA screening outweigh the risks? Watch video of a roundtable discussion, participate in a poll, and contribute your comments in our Clinical Directions feature — Screening for Prostate Cancer. Commenting closes April 1, 2009.

ABSTRACT

Background The European Randomized Study of Screening for Prostate Cancer was initiated in the early 1990s to evaluate the effect of screening with prostate-specific–antigen (PSA) testing on death rates from prostate cancer.

Methods We identified 182,000 men between the ages of 50 and 74 years through registries in seven European countries for inclusion in our study. The men were randomly assigned to a group that was offered PSA screening at an average of once every 4 years or to a control group that did not receive such screening. The predefined core age group for this study included 162,243 men between the ages of 55 and 69 years. The primary outcome was the rate of death from prostate cancer. Mortality follow-up was identical for the two study groups and ended on December 31, 2006.

Results In the screening group, 82% of men accepted at least one offer of screening. During a median follow-up of 9 years, the cumulative incidence of prostate cancer was 8.2% in the screening group and 4.8% in the control group. The rate ratio for death from prostate cancer in the screening group, as compared with the control group, was 0.80 (95% confidence interval [CI], 0.65 to 0.98; adjusted P=0.04). The absolute risk difference was 0.71 death per 1000 men. This means that 1410 men would need to be screened and 48 additional cases of prostate cancer would need to be treated to prevent one death from prostate cancer. The analysis of men who were actually screened during the first round (excluding subjects with noncompliance) provided a rate ratio for death from prostate cancer of 0.73 (95% CI, 0.56 to 0.90).

Conclusions PSA-based screening reduced the rate of death from prostate cancer by 20% but was associated with a high risk of overdiagnosis. (Current Controlled Trials number, ISRCTN49127736 [controlled-trials.com] .)


Source Information

The authors' affiliations are listed in the Appendix.

This article (10.1056/NEJMoa0810084) was published at NEJM.org on March 18, 2009.

Address reprint requests to Dr. Schröder at the Erasmus Medical Center, P.O. Box 2040, Rotterdam 3000 CA, the Netherlands, or at secr.schroder{at}erasmusmc.nl.

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Related Letters:

Prostate-Cancer Screening
Catalona W. J., Preston S. H., Cooperberg M. R., Carroll P. R., Ojha R. P., Thertulien R., Fischbach L. A., Izmirlian G., Dubben H.-H., Andriole G. L., Miller A. B., Berg C. D., the PLCO Project Team , Schröder F. H., Roobol M., Moss S., the ERSPC Investigators
Extract | Full Text | PDF  
N Engl J Med 2009; 361:202-206, Jul 9, 2009. Correspondence

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