Randomized Controlled Trial

. 2019 Jul;76(1):43-51.

doi: 10.1016/j.eururo.2019.02.009. Epub 2019 Feb 26.

A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer

Jonas Hugosson¹, Monique J Roobol², Marianne Månsson³, Teuvo L J Tammela⁴, Marco Zappa⁵, Vera Nelen⁶, Maciej Kwiatkowski⁷, Marcos Lujan⁸, Sigrid V Carlsson⁹, Kirsi M Talala¹⁰, Hans Lilja¹¹, Louis J Denis¹², Franz Recker¹³, Alvaro Paez¹⁴, Donella Puliti⁵, Arnauld Villers¹⁵, Xavier Rebillard¹⁶, Tuomas P Kilpeläinen¹⁷, Ulf H Stenman¹⁸, Rebecka Arnsrud Godtman³, Karin Stinesen Kollberg³, Sue M Moss¹⁹, Paula Kujala¹⁸, Kimmo Taari¹⁷, Andreas Huber²⁰, Theodorus van der Kwast²¹, Eveline A Heijnsdijk²², Chris Bangma², Harry J De Koning²², Fritz H Schröder², Anssi Auvinen²³; ERSPC investigators

Affiliations

¹ Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.
² Erasmus Medical Centre, Rotterdam, The Netherlands.
³ Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.
⁴ University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.
⁵ ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.
⁶ Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.
⁷ Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.
⁸ Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.
⁹ Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
¹⁰ Finnish Cancer Registry, Helsinki, Finland.
¹¹ Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.
¹² Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.
¹³ Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.
¹⁴ Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.
¹⁵ Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.
¹⁶ Urology Department, Clinique Beau Soleil, Montpellier, France.
¹⁷ Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
¹⁸ Department of Pathology, Fimlab Laboratories, Tampere, Finland.
¹⁹ Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.
²⁰ Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.
²¹ Laboratory Medicine Program, University Health Network, Toronto, Canada.
²² Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.
²³ Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.

PMID: 30824296
PMCID: PMC7513694
DOI: 10.1016/j.eururo.2019.02.009

Randomized Controlled Trial

A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer

Jonas Hugosson et al. Eur Urol. 2019 Jul.

. 2019 Jul;76(1):43-51.

doi: 10.1016/j.eururo.2019.02.009. Epub 2019 Feb 26.

Authors

Affiliations

¹ Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.
² Erasmus Medical Centre, Rotterdam, The Netherlands.
³ Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.
⁴ University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.
⁵ ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.
⁶ Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.
⁷ Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.
⁸ Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.
⁹ Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
¹⁰ Finnish Cancer Registry, Helsinki, Finland.
¹¹ Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.
¹² Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.
¹³ Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.
¹⁴ Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.
¹⁵ Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.
¹⁶ Urology Department, Clinique Beau Soleil, Montpellier, France.
¹⁷ Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
¹⁸ Department of Pathology, Fimlab Laboratories, Tampere, Finland.
¹⁹ Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.
²⁰ Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.
²¹ Laboratory Medicine Program, University Health Network, Toronto, Canada.
²² Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.
²³ Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.

PMID: 30824296
PMCID: PMC7513694
DOI: 10.1016/j.eururo.2019.02.009

Abstract

Background: The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality.

Objective: To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended.

Design, setting, and participants: This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry.

Outcome measurements and statistical analysis: The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended.

Results and limitations: The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently.

Conclusions: Findings corroborate earlier results that PSA screening significantly reduces PCa mortality, showing larger absolute benefit with longer follow-up and a reduction in excess incidence. Repeated screening may be important to reduce PCa mortality on a population level.

Patient summary: In this report, we looked at the outcomes from prostate cancer in a large European population. We found that repeated screening reduces the risk of dying from prostate cancer.

Keywords: Mortality; Prostate cancer; Prostate-specific antigen; Screening.

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Figures

**Figure 1:. Trial profile (core age group).**
GS=Gleason score. M1=evidence of metastases on imaging or PSA >100 ng/mL. PSA=prostate-specific antigen. *Missing=missing T stage or GS, not M1 or PSA <100. †Low risk= T1, and T1 with GS ≤6. ‡=Intermediate risk= T1, and T2 with GS 7 and T3 with GS ≤7. §High risk= T1, and T2, and T3 with GS 8-10 and T4 with any GS. ¶ M1 or PSA >100 might occur, any T stage, or GS.

**Figure 2:**
Prostate cancer incidence estimated by the Nelson-Aalen and competing risk approach respectively (a and c), and prostate cancer specific mortality estimated by the Nelson-Aalen and competing risk approach respectively (b and d).

**Figure 3:**
Prostate cancer specific survival in those detected during screening round 1 and those detected during repeated screening.

See this image and copyright information in PMC

Comment in

Solid Science for the Upside but Lack of Solid Science for the Downside-Towards Cutting-edge Prostate-cancer Screening.
Steineck G, Akre O, Bill-Axelson A. Steineck G, et al. Eur Urol. 2019 Jul;76(1):52-53. doi: 10.1016/j.eururo.2019.03.043. Epub 2019 Apr 8. Eur Urol. 2019. PMID: 30975451 No abstract available.
Re: Jonas Hugosson, Monique J. Roobol, Marianne Månsson, et al. A 16-yr Follow-up of the European Randomized Study of Screening for Prostate Cancer. Eur Urol 2019;76:43-51: Mortality in the Age Group ≥70 yr and the Case of Italy.
Donzelli A, Castelluzzo G, Giudicatti G. Donzelli A, et al. Eur Urol. 2020 Mar;77(3):e70-e71. doi: 10.1016/j.eururo.2019.07.045. Epub 2019 Aug 20. Eur Urol. 2020. PMID: 31443958 No abstract available.
Editorial Comment: A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.
Lott F. Lott F. Int Braz J Urol. 2020 May-Jun;46(3):465-466. doi: 10.1590/S1677-5538.IBJU.2020.03.06. Int Braz J Urol. 2020. PMID: 32167717 Free PMC article. No abstract available.

References

1. Schroder FH, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009;360:1320–8. - PubMed
1. Schroder FH, et al. Prostate-cancer mortality at 11 years of follow-up. N Engl J Med 2012;366:981–90. - PMC - PubMed
1. Schroder FH, et al. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet 2014;384:2027–35. - PMC - PubMed
1. Martin RM, et al. Effect of a low-intensity PSA-based screening intervention on prostate cancer mortality: the CAP randomized clinical trial. JAMA 2018;319:883–95. - PMC - PubMed
1. ERSPC webpage. 2017. http://www.erspc.org/

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A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer

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A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer

Authors

Affiliations

Abstract

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Comment in

References

Publication types

MeSH terms

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Grants and funding

LinkOut - more resources

Full Text Sources

Medical

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Miscellaneous