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Reevaluating Screening Trial Data: Important New Study Shows PSA Screening Saves Lives… “Contamination” in PLCO Trial In recent years, the PLCO trial has been criticized for its high “contamination” rate in the control arm. This means that the majority of men in the control arm actually underwent PSA testing. About 50% of men in the control group had PSA testing before enrolling in the study. In addition, an independent re-analysis of PLCO data by Shoag et al. in 2016 found that nearly 90% of men in the control arm had PSA tests before or during the trial. These high rates of PSA testing in the control group skewed the data against screening. The new analysis from the Cancer Intervention and Surveillance Modeling Network of the National Cancer Institute managed the PLCO contamination rate by comparing groups of men in both studies to an unscreened population to “capture the intensity of screening in each group.” (continued from page 2.) Effect of PLCO on USPSTF When writing its earlier recommendations against PSA testing, the U.S. Preventive Services Task Force (USPSTF) heavily weighed the negative PLCO trial, relying on the incorrectly reported 50% rate of PSA testing in the control arm in its initial report. In 2008, the USPSTF recommended against screening men older than 75 years. In 2009, following the first published results from ERSPC and PLCO, the USPSTF immediately began a new evidence review, one year ahead of schedule and, in 2012, issued a grade “D” recommendation against screening for all men, concluding “harms outweigh benefits.” The USPSTF panel included no urologists, radiation oncologists or medical oncologists. Following the grade “D” recommendation, PSA screening and prostate cancer interventions declined, rates of diagnoses of local/regional disease has decreased, but distant disease at diagnosis began to increase. Despite fewer prostate cancer cases overall, there is a higher absolute number of metastatic cases at diagnosis. Shoag et al. pointed out that before their re-analysis, guideline panels did The Impact of PSA Testing I n the U.S. during the PSA era, there has been an 80% decrease in the percentage of men with metastases at diagnosis and a more than 53% decrease in prostate cancer mortality. Statistical modeling studies estimate that stopping screening would result in twice as many metastatic cases, returning to pre-PSA era levels by 2025, and a 13-20% increase in preventable prostate cancer deaths. Not screening men older than 70 years would fail to prevent 36-39% of avoidable prostate cancer deaths. not realize the high extent of contamination in PLCO and speculated that millions of men have not been offered PSA screening because of a lack of knowledge of this shortcoming. The USPSTF has now backed away from its PSA screening ban and issued a new draft grade “C” recommendation for screening men ages 55 to 69. “This is a good start,” said Dr. William J. Catalona, “but more revision is needed. Baseline screening for risk should be performed in men ages 40 to 54, healthy men 70 years or older also should be screened, and more intensive screening is indicated for high-risk men—men with African heritage, family history, or carriers of genetic risk factors.” In an editorial accompanying the analysis, Andrew J. Vickers, PhD, said “The controversy about PSA-based screening should no longer be whether it can do good but whether we can change our behavior so that it does more good than harm.” Ann Intern Med. 2017 Oct 3;167(7):449-455. doi: 10.7326/M16-2586. Epub 2017 Sep 5. Ann Intern Med. 2017 Oct 3;167(7):509-510. doi: 10.7326/M17-2012. Epub 2017 Sep 5 Contact Information for Dr. Catalona Returning patients : New patients : (312) 695-8146 (312) 695-4471 If you are unable to schedule a timely appointment, contact Dr. Catalona by phone at 312-695-4471 or mobile text at 314-974-4457. Q uest The mission of the Urological Research Foundation is to support research and patient education in prostate cancer. Q UEST is a free newsletter, but we need and appreciate your voluntary contributions. Q UEST is published three times a year by the Urological Research Foundation. ©2017 Urological Research Foundation No material reproduced without permission. Circulation: 42,000 Medical Editor: William J. Catalona, M.D. Editor: Betsy Haberl Graphics: Amy L. Davis 2 To subscribe to Q UEST , send your name and address to: Q UEST , PO Box 855, Manchester, MO 63011 . To receive Q UEST by email, send your request to To unsubscribe, email your name and address to Find Q UEST online at: Q UEST Winter 2017

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