To examine prostate cancer incidence and mortality by arm in the randomized Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial.
Subjects aged 55-74 at 10 screening centers were randomized between 1993 and 2001 to an intervention or usual care arm. Intervention arm men received 6 annual prostate-specific antigen (PSA) tests and 4 annual digital rectal exams. Subjects were followed for prostate cancer (PCa) incidence and for mortality by active follow-up processes and by linkage to state cancer registries and the National Death Index. For cancers identified by active follow-up, trial abstractors recorded the mode of diagnosis (screen detected, symptomatic, other).
38340 men were randomized to the intervention arm and 38343 to usual care. Median follow-up for mortality was 16.9 (intervention) and 16.7 (usual care) years. There were 333 (intervention) and 352 (usual care) PCa cancer deaths, giving rates (per 10,000 PY) of 5.5 and 5.9, respectively, and an RR of 0.93 (95% CI: 0.81-1.08; p=0.38). The rate ratio (RR) for overall PCa incidence was 1.05 (95% CI: 1.01-1.09); by Gleason category, it was 1.17 (95% CI: 1.11-1.23), 1.00 (95% CI: 0.93-1.07) and 0.89 (95% CI; 0.80-0.99) for Gleason 2-6, 7 and 8-10, respectively. By mode of detection, during the trial's screening phase, 12% of intervention arm versus 27% of usual care arm cases were symptomatic; post-screening these percentages were 18% in each arm.
After almost 17 years median follow-up, there was no significant reduction in prostate cancer mortality in the intervention compared to usual care arm. There was a significant increase in Gleason 2-6 disease and a significant reduction in Gleason 8-10 disease in the intervention compared to usual care arm. This article is protected by copyright. All rights reserved.
BJU international. 2018 Oct 05 [Epub ahead of print]
P F Pinsky, E Miller, P Prorok, R Grubb, E D Crawford, G Andriole
Division of Cancer Prevention, National Cancer Institute, NIH, Bethesda, MD., Medical University of South Carolina, Charleston, SC., University of Colorado Health Sciences, Denver, CO., Washington University School of Medicine, St. Louis, MO.