This report presents interim results from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial on prostate-cancer mortality. From 1993 through 2001, 76,693 men were randomised to either 6 rounds of annual screening with prostate-specific antigen (PSA) plus 4 annual digital rectal exams (DREs; n=38,343) or to usual care as the control (n=38,350). Usual care sometimes included screening, as some organisations have recommended. 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. At 7 years’ follow-up, screening was associated with a relative increase of 22% in the rate of prostate cancer diagnosis, compared with the control group. However, over an 11-year median follow-up, combined screening with PSA testing and a DRE did not reduce mortality; the rate of death from prostate cancer was very low and did not differ significantly between the two study groups.
