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Evidence of Benefit


    The Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) is a multicenter, randomized two-armed trial designed to evaluate the effect of screening for prostate, lung, colorectal, and ovarian cancers on disease-specific mortality. From 1993 through 2001, 76,693 men at ten U.S. study centers were randomly assigned to receive 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 DRE 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.

    In the screening group, rates of compliance were 85% for PSA testing and 86% for DRE. Self-reported 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 DRE. Results from the first four rounds of screening are shown in the Summary of First Four Prostate, Lung, Colorectal, and Ovarian Screening Rounds table.[46]

    Summary of First Four Prostate, Lung, Colorectal, and Ovarian Screening Roundsa

    DRE = digital rectal exam; PSA = prostate-specific antigen; T = tumor.
    a Adapted from Grubb et al.[46]
     T0 (Baseline)T1T2T3
    Number Tested (PSA or DRE)34,26232,69631,69730,544
    PSA positive (>4 ng/mL) (%)
    DRE positive (%)
    Either test positive (%)14.013.514.415.1
    Biopsies and Cancers    
    PSA >4 ng/mL2,7182,5022,5932,676
    Cancers/1,000 screened14.
    DRE abnormal and PSA ≤4 ng/mL2,0831,9231,9731,943
    Cancers/1,000 screened1.
    PSA >4 ng/mL or DRE abnormal4,8014,4254,5664,619
    Cancers/1,000 screened16.011.510.811.1

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