Serum prostate-specific antigen (PSA) testing is controversial due to its low specificity and high false positives. Further, when PSA testing accurately identifies prostate cancer, it cannot distinguish between harmful and indolent prostate cancers. The PLCO trial was a large randomized control trial of nearly 155,000 men and women. Eligible participants were between 55 and 74, conducted from 1993-2001, funded by the National Cancer Institute that assessed the utility of screening programs for prostate and lung colorectal and ovarian cancer.
Participants enrolled in the trial had no history of these cancers. The primary endpoint of the PLCO Trial was to determine if screening for these cancers improved cancer-related mortality. Men and women randomly assigned to the screening group of the PLCO trial underwent colorectal screening with flexible sigmoidoscopy and lung cancer screening with a chest x-ray. Men randomly assigned to the screening group also received prostate screening with digital rectal exam and PSA tests. Women randomly assigned to the screening group were also screened for ovarian cancer with serum CA-125 and transvaginal ultrasound testing. All participants randomly assigned to the control group received no screening for prostate, lung, colorectal, or ovarian cancers.
Prostate cancer screening results were: 7.5% of men had a DRE suspicious for cancer, 7.9% had a PSA above 4 ng/mL, and 1.4% were diagnosed with prostate cancer, mainly localized prostate cancer. Of those with positive prostate cancer screening, 74% received additional evaluation (31% underwent prostate biopsy). Findings concerning prostate screening with digital rectal exam and PSA testing were not too bad. Still only a USPSTF Grade C recommendation, though, today.
References:
Andriole GL, Levin DL, Crawford ED, et al. Prostate Cancer Screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: Findings From the Initial Screening Round of a Randomized Trial, JNCI: Journal of the National Cancer Institute, Volume 97, Issue 6, 16 March 2005, Pages 433–438, https://doi.org/10.1093/jnci/dji065
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