Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Mar 26;360(13):1310-9.
doi: 10.1056/NEJMoa0810696. Epub 2009 Mar 18.

Mortality results from a randomized prostate-cancer screening trial

Gerald L Andriole  1 , E David Crawford, Robert L Grubb 3rd, Saundra S Buys, David Chia, Timothy R Church, Mona N Fouad, Edward P Gelmann, Paul A Kvale, Douglas J Reding, Joel L Weissfeld, Lance A Yokochi, Barbara O'Brien, Jonathan D Clapp, Joshua M Rathmell, Thomas L Riley, Richard B Hayes, Barnett S Kramer, Grant Izmirlian, Anthony B Miller, Paul F Pinsky, Philip C Prorok, John K Gohagan, Christine D Berg; PLCO Project Team
Collaborators, Affiliations
Randomized Controlled Trial

Mortality results from a randomized prostate-cancer screening trial

Gerald L Andriole et al. N Engl J Med. .

Erratum in

  • N Engl J Med. 2009 Apr 23;360(17):1797

Abstract

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

Methods: From 1993 through 2001, we randomly assigned 76,693 men 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 for 6 years and digital rectal examination for 4 years. The subjects and health care providers received the results and decided on the type of follow-up evaluation. Usual care sometimes included screening, as some organizations have recommended. The numbers of 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. Rates of screening in the control group increased from 40% in the first year to 52% in the sixth year for PSA testing and ranged from 41 to 46% for digital rectal examination. After 7 years of follow-up, the incidence of prostate cancer per 10,000 person-years was 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-years was 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 these overall findings.

Conclusions: After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups. (ClinicalTrials.gov number, NCT00002540.)

PubMed Disclaimer

Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1
Number of Diagnoses of All Prostate Cancers (Panel A) and Number of Prostate-Cancer Deaths (Panel B).
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Potosky AL, Miller BA, Albertsen PC, Kramer BS. The role of increasing detection in the rising incidence of prostate cancer. JAMA. 1995;273:548–552. - PubMed
    1. Lin K, Lipsitz R, Miller T, Janakiraman S. Benefits and harms of prostate-specific antigen screening for prostate cancer: an evidence update for the U.S. Preventive Services Task Force. Ann Intern Med. 2008;149:192–199. - PubMed
    1. American Urological Association (AUA) Prostate-specific antigen (PSA) best practice policy. Oncology (Williston Park) 2000;14:267–272. 277-8, 280 passim. - PubMed
    1. American Cancer Society guidelines for the early detection of cancer. [Accessed March 6, 2009]. at http://www.cancer.org/docroot/ped/content/ped_2_3x_acs_cancer_detection_....
    1. Kawachi MH, Bahnson RR, Barry M, et al. National Comprehensive Cancer Network clinical practice guidelines in oncology: prostate cancer early detection (v.2.2007) [Accessed March 6, 2009]. at http://www.nccn.org/professionals/physician_gls/PDF/prostate_detection.pdf. - PubMed

Publication types

Substances

Associated data