Abstract
The two-year pilot phase of the Prostate, Lung, Colorectal, and Ovarian (PLCO) trial concluded September 29, 1994. The goals, organization, operation, and recruitment status of the trial are discussed. The PLCO trial is a 16-year randomized controlled screening trial involving 148,000 male and female participants. Screening for prostate cancer is by prostate specific antigen and digital rectal examination. A coordinating center and 10 screening centers located across the United States, a laboratory for prostate specific antigen and CA125 assays, and a biore-pository are the primary components of the trial. Scientific direction is provided by National Cancer Institute scientific staff, a steering committee of study investigators, external expert consultants, and a data monitoring panel. Evaluation of the pilot phase is focused on recruitment; screening operations, including quality assurance ; compliance ; data management ; and blood processing. Pilot phase results are anticipated in 1995. Cancer 1995 ; 75 : 1869-73.
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