Background: The European Randomised study of Screening for Prostate Cancer (ERSPC) has shown significant reductions in prostate cancer mortality after 9 years and 11 years of follow-up, but screening is controversial because of adverse events such as overdiagnosis. We provide updated results of mortality from prostate cancer with follow-up to 2010, with analyses truncated at 9, 11, and 13 years.
Methods: ERSPC is a multicentre, randomised trial with a predefined centralised database, analysis plan, and core age group (55—69 years), which assesses prostate-specific antigen (PSA) testing in eight European countries. Eligible men aged 50—74 years were identified from population registries and randomly assigned by computer generated random numbers to screening or no intervention (control). Investigators were masked to group allocation. The primary outcome was prostate cancer mortality in the core age group. Analysis was by intention to treat. We did a secondary analysis that corrected for selection bias due to non-participation. Only incidence and no mortality data at 9 years’ follow-up are reported for the French centres. This study is registered with Current Controlled Trials, number ISRCTN49127736.
Findings: With data truncated at 13 years of follow-up, 7408 prostate cancer cases were diagnosed in the intervention group and 6107 cases in the control group. The rate ratio of prostate cancer incidence between the intervention and control groups was 1·91 (95% CI 1·83—1·99) after 9 years (1·64 [1·58—1·69] including France), 1·66 (1·60—1·73) after 11 years, and 1·57 (1·51—1·62) after 13 years. The rate ratio of prostate cancer mortality was 0·85 (0·70—1·03) after 9 years, 0·78 (0·66—0·91) after 11 years, and 0·79 (0·69—0·91) at 13 years. The absolute risk reduction of death from prostate cancer at 13 years was 0·11 per 1000 person-years or 1·28 per 1000 men randomised, which is equivalent to one prostate cancer death averted per 781 (95% CI 490—1929) men invited for screening or one per 27 (17—66) additional prostate cancer detected. After adjustment for non-participation, the rate ratio of prostate cancer mortality in men screened was 0·73 (95% CI 0·61—0·88).
Interpretation: In this update the ERSPC confirms a substantial reduction in prostate cancer mortality attributable to testing of PSA, with a substantially increased absolute effect at 13 years compared with findings after 9 and 11 years. Despite our findings, further quantification of harms and their reduction are still considered a prerequisite for the introduction of populated-based screening.
Funding: Each centre had its own funding responsibility.
Click HERE to listen to one of the authors, Fritz H. Schröder MD, discuss this review
Click HERE to listen to a commentary by the editor-in-chief, Thomas Keane, MD
Prof Fritz H Schröder MD,a Prof Jonas Hugosson PhD,b Monique J Roobol PhD,a Prof Teuvo L J Tammela MD,c, d Marco Zappa MD,e Vera Nelen MD,f Maciej Kwiatkowski MD,g, h Marcos Lujan MD,i, j, k Liisa Määttänen PhD,l Prof Hans Lilja PhD MD,m, n, o, p, q Prof Louis J Denis MD,r Prof Franz Recker MD,g Alvaro Paez MD,s, t, u Prof Chris H Bangma MD,a Sigrid Carlsson MD,b, m Donella Puliti MS,c, e Arnauld Villers MD,v Xavier Rebillard MD,w Prof Matti Hakama PhD,l, x Prof Ulf-Hakan Stenman PhD,y Paula Kujala MD,z Kimmo Taari MD,aa Gunnar Aus MD,ab Prof Andreas Huber MD,ac Prof Theo H van der Kwast PhD MD,ad Prof Ron H N van Schaik PhD,ae Prof Harry J de Koning MD,af Prof Sue M Moss PhD,ag Prof Anssi Auvinen MD,x for the ERSPC Investigators† Are you the author?
aDepartment of Urology, Erasmus University Medical Center, Rotterdam, Netherlands
bDepartment of Urology, Sahlgrenska Academy at Goteborg University, Goteborg, Sweden
cDepartment of Urology, Tampere University Hospital, Tampere, Finland
dSchool of Medicine, University of Tampere, Tampere, Finland
eUnit of Clinical and Descriptive Epidemiology, ISPO, Florence, Italy
fProvinciaal Instituut voor Hygiene, Antwerp, Belgium
gDepartment of Urology, Kantonsspital Aarau, Aarau, Switzerland
hDepartment of Urology, Academic Hospital Braunschweig, Braunschweig, Germany
iDepartment of Urology, Hospital Infanta Cristina, Parla, Madrid, Spain
jDepartment of Urology, Hospital Universitario de Getafe, Getafe, Madrid, Spain
kUniversidad Complutense de Madrid, Madrid, Spain
lFinnish Cancer Registry, Helsinki, Finland
mDepartment of Surgery (Urology), Memorial Sloan-Kettering Cancer Center, New York, NY, USA
nDepartments of Laboratory Medicine and Medicine (GU-Oncology), Memorial Sloan-Kettering Cancer Center, New York, NY, USA
oNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK
pDepartment of Laboratory Medicine, Lund University, Malmö, Sweden
qInstitute of Biomedical Technology, University of Tampere, Tampere, Finland
rOncology Centre Antwerp, Antwerp, Belgium
sDepartment of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain
tDepartment of Urology, Hospital Universitario de Getafe, Getafe, Madrid, Spain
uUniversidad Rey Juan Carlos, Madrid, Spain
vDepartment of Urology, CHU Lille, Univ Lille Nord de France, Lille, France
wService d'Urologie, Clinique BeauSoleil, Montpellier, France
xSchool of Health Sciences, University of Tampere, Tampere, Finland
yDepartment of Clinical Chemistry, Helsinki University Central Hospital Laboratory Division (HUSLAB), Helsinki, Finland zFIMLAB, Department of Pathology, Tampere, Finland
aaDepartment of Urology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland
abDepartment of Urology, Carlanderska Sjukhuset Göteborg, Sweden
acCentre of Laboratory Medicine, Kantonsspital Aarau, Aarau, Switzerland
adDepartment of Pathology, Erasmus University Medical Center, Rotterdam, Netherlands
aeDepartment of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, Netherlands
afDepartment of Public Health, Erasmus University Medical Center, Rotterdam, Netherlands
agCentre for Cancer Prevention, Queen Mary University of London, London, UK
Reference: The Lancet, Early Online Publication, 7 August 2014