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Randomized Controlled Trial
. 2012 Mar 15;366(11):981-90.
doi: 10.1056/NEJMoa1113135.

Prostate-cancer mortality at 11 years of follow-up

Fritz H Schröder  1 , Jonas Hugosson, Monique J Roobol, Teuvo L J Tammela, Stefano Ciatto, Vera Nelen, Maciej Kwiatkowski, Marcos Lujan, Hans Lilja, Marco Zappa, Louis J Denis, Franz Recker, Alvaro Páez, Liisa Määttänen, Chris H Bangma, Gunnar Aus, Sigrid Carlsson, Arnauld Villers, Xavier Rebillard, Theodorus van der Kwast, Paula M Kujala, Bert G Blijenberg, Ulf-Hakan Stenman, Andreas Huber, Kimmo Taari, Matti Hakama, Sue M Moss, Harry J de Koning, Anssi Auvinen; ERSPC Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Prostate-cancer mortality at 11 years of follow-up

Fritz H Schröder et al. N Engl J Med. .

Erratum in

  • N Engl J Med. 2012 May 31;366(22):2137

Abstract

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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Figures

Figure 1
Figure 1. Flow diagram of the ERSPC trial
* Low risk= T1,T2 with Gleason score (GS) <= 6; Intermediate risk = T1,T2 with GS 7 and T3 with GS <=7; High risk = T1,T2,T3 with GS 8-10 and T4 with any GS; M1 and/or PSA > 100 = any T stage or GS with M1 and/or PSA > 100. § More detailed data on prognostic factors are provided in tables 5A, 5B and 5C of the supplementary appendix
Figure 2
Figure 2
Cumulative mortality from prostate cancer in the core age group, excluding France
See this image and copyright information in PMC

Comment in

References

    1. Schröder FH, Hugosson J, Roobol MJ, Tammela TLJ, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Berenguer A, Määttänen L, Bangma CH, Aus G, Villers A, Rebillard X, van der Kwast TH, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A for the ERSPC Investigators. Screening and prostate-cancer mortality in a randomized European Study. N Engl J Med. 2009 Mar 26;360(13):1320–8. - PubMed
    1. Roobol MJ, Schröder FH. The European Randomized study of Screening for Prostate Cancer (ERSPC): rationale, structure and preliminary results 1994-2003. BJU Int. 2003 Dec;92(Suppl 2) - PubMed
    1. [1.12.2011]; http://www.erspc.org/publist.php / study protocol 1994, admission criteria and minimal data set. Section 4.0 definitions, 4.1 age groups.
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    1. De Koning HJ, Blom J, Merkelbach JW, Raaijmakers R, Verhaegen H, Van Vliet P, Nelen V, Coebergh JWW, Hermans A, Ciatto S, Mäkinen T. Determining the cause of death in randomized screening trial(s) for prostate cancer. BJU Int. 2003 Dec;92(Suppl 2):71–8. - PubMed

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