Mortality Results From A Randomized Prostate-Cancer Screening Trial

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials
Article Date: 25 Apr 2009 - 5:00 PDT

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UroToday.com - The use of PSA screening for the detection and treatment of prostate cancer (CaP) has been controversial. Two articles on this topic appear in the March 18, 2009 online edition of the New England Journal of Medicine. This article by Dr. Gerald Andriole and associates and the other by Professor Fritz Schöder and colleagues are both reviewed in Urotoday.

This report is from the Prostate, Lung, Colorectal and Ovarian (PLOC) cancer screening trial, which was designed to assess the effect of annual PSA testing and DRE on mortality from CaP. From 1993 to 2001, 76,693 men at 10 US study centers were randomized to either annual PSA testing for 6 years with DRE for 4 years or usual care. Demographic data was collected and a biorepository established. All PSA tests were performed at a single laboratory. The primary study endpoint was cause-specific survival. The data safety monitoring board recommended this report be issued, due to a lack of a significant difference in the death rate between the two study groups at 10 years (and including complete follow-up at 7 years).

Compliance with the screening protocol was 85% for PSA testing and 86% for DRE. The usual care control group had PSA testing in 40% in the first year that increased to 52% in the sixth year. At year 7, 2,820 cases of CaP were diagnosed in the screened group compared to 2,322 in the control group. This increased at year 10 (with 67% of participants having complete follow-up) to 3,452 and 2,974, respectively. Overall the number of men with advanced CaP was similar between groups, although the number with Gleason score 8-10 was higher in the control group. Treatment choice among participants diagnosed with CaP in both groups was similar. Regarding mortality, 50 deaths were due to CaP in the screened group compared to 44 in the control group at year 7 which increased to 92 and 82 deaths at 10 years, respectively. The screening status at baseline showed no indication of any reduction in CaP mortality in the screening group, compared to the control group.

The authors also discuss risks associated with screening to include the screening itself and diagnostic and therapeutic interventions. Although not common, medical complications occurred at a rate of 26.2 and 68 per 10,000 screenings for the PSA test and biopsy, respectively.

Andriole GL, Grubb RL 3rd, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, Crawford ED, O'Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD; PLCO Project Team.
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N Engl J Med. 2009 Mar 26;360(13):1310-9

Written by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

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