BACKGROUND: Several trials evaluating the effect of prostate-specific antigen (PSA) testing on prostate-cancer mortality have shown conflicting results. We updated prostate-cancer mortality in the European Randomized Study of Screening for Prostate Cancer with 2 additional years of follow-up.
METHODS: The study involved 182,160 men between the ages of 50 and 74 years at entry, with a predefined core age group of 162,388 men 55 to 69 years of age. The trial was conducted in eight European countries. Men who were randomly assigned to the screening group were offered PSA-based screening, whereas those in the control group were not offered such screening. The primary outcome was mortality from prostate cancer.
RESULTS : After a median follow-up of 11 years in the core age group, the relative reduction in the risk of death from prostate cancer in the screening group was 21% (rate ratio, 0.79; 95% confidence interval [CI], 0.68 to 0.91; P=0.001), and 29% after adjustment for noncompliance. The absolute reduction in mortality in the screening group was 0.10 deaths per 1000 person-years or 1.07 deaths per 1000 men who underwent randomization. The rate ratio for death from prostate cancer during follow-up years 10 and 11 was 0.62 (95% CI, 0.45 to 0.85; P=0.003). To prevent one death from prostate cancer at 11 years of follow-up, 1055 men would need to be invited for screening and 37 cancers would need to be detected. There was no significant between-group difference in all-cause mortality.
CONCLUSIONS: Analyses after 2 additional years of follow-up consolidated our previous finding that PSA-based screening significantly reduced mortality from prostate cancer but did not affect all-cause mortality. (Current Controlled Trials number, ISRCTN49127736.).
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Schröder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Páez A, Määttänen L, Bangma CH, Aus G, Carlsson S, Villers A, Rebillard X, van der Kwast T, Kujala PM, Blijenberg BG, Stenman UH, Huber A, Taari K, Hakama M, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators.Kirkels WJ, Rietbergen JB, van der Cruijsen IW, Raaijmakers R, de Vries SH, Roemeling S, Gosselaar C, Wolters T, van den Bergh RC, van Leeuwen PJ, Bul M, Zhu X, van Vugt HA, Yurdakul G, Boeken-Kruger A, Wijburg C, Forouzanfor M, de Boer M, Postma R, Vis AN, Hoedemaeker R, van Leenders A, van Schaik R, van der Maas PJ, Otto S, Draisma G, Beemsterboer P, Essink-Bot M, Korfage I, Boer R, Wildhagen M, Heijnsdijk E, Merkelbach W, Hoekstra W, Blom J, Damhuis RA, Reedijk A, Kranse R, Roobol DW, Roobol W, van den Berg E, de Zwart GJ, Franken-Raab CG, van Slooten-Midderig M, Smit A, van der Drift V, de Bilde E, Mani L, Visser-van Dongen M, Versteeg-Leenheer H, Zoutendijk B, Vink N, van Meurs H, de Bruijn AE, Venderbos LD, Devriendt H, Thijs G, Hermans A, D'Hooge K, Neels H, Wauters A, Neetens I, Kockx M, Keuppens F, Braeckman J, Govaerts F, Spinnewijn B, Van Hoey M, Putzeys T, De Coninck M, Dourcy-Belle-Rose B, Vancauwenbergh A, Coebergh JW, Verhaegen H, Van Vliet, Standaert B, Van Herck L, Nyberg M, Bergdahl S, Lodding P, Khatami A, Stranne J, Ahlgren H, Eriksson GB, Becker C, Carlsson S, Grenabo A, Pettersson S, Varenhorst E, Norlén BJ, Zackrisson B, Holmberg E, Frösing R, Pileblad E, Pihl CG, Laurila M, Ruutu M, Aro J, Juusela H, Mildh M, Lahtela J, Karhunen PJ, Mäkinen T, Rannikko A, Malila N, Kilpeläinen T, Murtola T, Kuivalainen S, Karhunen T, Cappellini M, Bianchi S, Lombardi C, Bussotti A, Bastiani P, Bonardi R, Mazzotta A, Bartoli D, Bonfrisco L, Crocetti E, Martinelli F, Zendron P, Frullini P, Di Lollo S, Rubeca T, Berenguer A, Rodriguez JA, Aybar B, Seiler D, Baumgartner M, Tscholl R, Woodtli E, Schärer L, Herklotz R, Stamm B, Wernli M, Bodis S, Grobholz R, Bubendorf L, Lehmann K, Schmid HR, Iselin HU, Steurer J, Kurrer M, Malavaud B, Iborra F, Malavaud S, Grosclaude P, Tretarre B, Bataille V, Bessaoud F, Hemming J, Coulson P, Coleman D, Van der Kwast T, van Leenders GJ, Hoedemaeker RF, Pihl CG, Martikainen PM, Laurila M, Bubendorf L, Santonja C, Neetens I, DiLollo S, Mazerolles C, Lopes C.
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Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Reference: N Engl J Med. 2012 Mar 15;366(11):981-90.
doi: 10.1056/NEJMoa1113135
PubMed Abstract
PMID: 22417251