EAU 2011 - Results from the Gothenburg randomized prostate cancer screening trial - Session Highlights

VIENNA, AUSTRIA (UroToday.com) - In 1994, 20,000 men born in Sweden between 1930 and 1944, randomly sampled from the population register, were randomized by computer in a 1:1 ratio to either a screening group invited for PSA testing every 2 years (n=10,000) or to a control group not invited (n=10,000).

Men in the screening group were invited up to the upper age limit (median 69, range 67–71 years) and only men with an elevated PSA level were offered additional tests such as digital rectal examination and prostate biopsies. The primary endpoint was prostate-cancer (CaP) specific mortality, analyzed according to the intention-to-screen principle. The study is ongoing, with men who have not reached the upper age limit invited for PSA testing. This was the first report from this database on cumulative CaP incidence and mortality calculated up to Dec 31, 2008.

In each group, 48 men were excluded from the analysis because of death or emigration before the randomization date, or prevalent CaP. In men randomized to screening, 7,578 (76%) of 9,952 attended at least once. During a median follow-up of 14 years, 1,138 men in the screening group and 718 in the control group were diagnosed with CaP, resulting in a cumulative CaP incidence of 12.7% in the screening group and 8.2% in the control group (hazard ratio 1.64; p<0·0001). The absolute cumulative risk reduction of death from CaP at 14 years was 0.40%, from 0.90% in the control group to 0.50% in the screening group. The rate ratio for death from CaP was 0.56 (p=0·002) in the screening compared with the control group. The rate ratio of death from CaP for attendees compared with the control group was 0.44 (p=0·0002). Overall, 293 men needed a screening invitation and 12 needed to be diagnosed in order to prevent one CaP death. The presenters concluded that in their study, CaP mortality was reduced almost by half over 14 years. This data suggests that the benefit of CaP screening compared favorably to other cancer screening programs. However, they cautioned that the risk of over-diagnosis is substantial and the number needed to treat is at least as high as in breast-cancer screening programs.


Presented by Jonas Hugosson, MD, et al. at the 26th Annual European Association of Urology (EAU) Congress - March 18 - 21, 2011 - Austria Centre Vienna, Vienna, Austria


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