Mortality Results from a Randomized Prostate-Cancer Screening Trial

doi:10.1056/NEJMoa0810696

A correction has been published: N Engl J Med 2009;360(17):1797.

Volume 360:1310-1319		March 26, 2009		Number 13

Mortality Results from a Randomized Prostate-Cancer Screening Trial

Gerald L. Andriole, M.D., E. David Crawford, M.D., Robert L. Grubb, III, M.D., Saundra S. Buys, M.D., David Chia, Ph.D., Timothy R. Church, Ph.D., Mona N. Fouad, M.D., Edward P. Gelmann, M.D., Paul A. Kvale, M.D., Douglas J. Reding, M.D., Joel L. Weissfeld, M.D., Lance A. Yokochi, M.D., Barbara O'Brien, M.P.H., Jonathan D. Clapp, B.S., Joshua M. Rathmell, M.S., Thomas L. Riley, B.S., Richard B. Hayes, Ph.D., Barnett S. Kramer, M.D., Grant Izmirlian, Ph.D., Anthony B. Miller, M.B., Paul F. Pinsky, Ph.D., Philip C. Prorok, Ph.D., John K. Gohagan, Ph.D., Christine D. Berg, M.D., for the PLCO Project Team

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by Lee, T. H.

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by Barry, M. J.

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

ABSTRACT

Background The effect of screening with prostate-specific–antigen(PSA) testing and digital rectal examination on the rate ofdeath from prostate cancer is unknown. This is the first reportfrom the Prostate, Lung, Colorectal, and Ovarian (PLCO) CancerScreening Trial on prostate-cancer mortality.

Methods From 1993 through 2001, we randomly assigned 76,693men at 10 U.S. study centers to receive either annual screening(38,343 subjects) or usual care as the control (38,350 subjects).Men in the screening group were offered annual PSA testing for6 years and digital rectal examination for 4 years. The subjectsand health care providers received the results and decided onthe type of follow-up evaluation. Usual care sometimes includedscreening, as some organizations have recommended. The numbersof all cancers and deaths and causes of death were ascertained.

Results In the screening group, rates of compliance were 85%for PSA testing and 86% for digital rectal examination. Ratesof screening in the control group increased from 40% in thefirst year to 52% in the sixth year for PSA testing and rangedfrom 41 to 46% for digital rectal examination. After 7 yearsof follow-up, the incidence of prostate cancer per 10,000 person-yearswas 116 (2820 cancers) in the screening group and 95 (2322 cancers)in the control group (rate ratio, 1.22; 95% confidence interval[CI], 1.16 to 1.29). The incidence of death per 10,000 person-yearswas 2.0 (50 deaths) in the screening group and 1.7 (44 deaths)in the control group (rate ratio, 1.13; 95% CI, 0.75 to 1.70).The data at 10 years were 67% complete and consistent with theseoverall findings.

Conclusions After 7 to 10 years of follow-up, the rate of deathfrom prostate cancer was very low and did not differ significantlybetween the two study groups. (ClinicalTrials.gov number, NCT00002540 [ClinicalTrials.gov] .)

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The authors' affiliations are listed in the Appendix.

This article (10.1056/NEJMoa0810696) was published at NEJM.org on March 18, 2009.

Address reprint requests to Dr. Berg at the Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, 6130 Executive Blvd., Rm. 3112, Bethesda, MD 20892-7346, or at bergc{at}mail.nih.gov.

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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
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N Engl J Med 2009; 361:202-206, Jul 9, 2009. Correspondence

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