Contact information
Type
Scientific
Primary contact
Mrs M. Roobol
ORCID ID
Contact details
Erasmus Medical Center
Department of Urology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4634548
m.roobol@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR156
Study information
Scientific title
European Randomised study of Screening for Prostate Cancer
Acronym
ERSPC
Study hypothesis
Screening causes a difference in prostate cancer mortality of 20% or more.
Ethics approval
Local medical ethics committee gave approval
Study design
Multicentre randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Prostate cancer
Intervention
Prostate Specific Antigen (PSA) determination followed by Digital Rectal Examination (DRE) and prostate biopsy if PSA greater than or equal to 3.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Prostate cancer mortality compared between the screened and the non-screened group of men at risk.
Secondary outcome measures
1. Progression-free (tumour free) survival
2. Survival free of metastatic disease
3. Quality of life in the screened and non-screened populations
Overall trial start date
01/10/1991
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Males aged 55 - 74 years (including age 74)
Participant type
Patient
Age group
Senior
Gender
Male
Target number of participants
251133
Participant exclusion criteria
Previous diagnosis of prostate cancer
Recruitment start date
01/10/1991
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Belgium, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
European Union (EU) (Belgium) - Fifth and Sixth Framework Programmes (FP5, FP6)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19297566
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21601352
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22264679
2012 11-year follow-up in: http://www.ncbi.nlm.nih.gov/pubmed/22417251
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22704366
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23954085
2014 13-year follow-up in: http://www.ncbi.nlm.nih.gov/pubmed/25108889
Publication citations
-
Results
Schröder FH, Hugosson J, Roobol MJ, Tammela TL, 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 T, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A, , Screening and prostate-cancer mortality in a randomized European study., N. Engl. J. Med., 2009, 360, 13, 1320-1328, doi: 10.1056/NEJMoa0810084.
-
Results
Zhu X, van Leeuwen PJ, Bul M, Otto SJ, de Koning HJ, Bangma CH, Schröder FH, Roobol MJ, Disease-specific survival of men with prostate cancer detected during the screening interval: results of the European randomized study of screening for prostate cancer-Rotterdam after 11 years of follow-up., Eur. Urol., 2011, 60, 2, 330-336, doi: 10.1016/j.eururo.2011.05.013.
-
Results
Wu GH, Auvinen A, Yen AM, Hakama M, Tammela TL, Stenman UH, Kujala P, Ruutu M, Chen HH, The impact of interscreening interval and age on prostate cancer screening with prostate-specific antigen., Eur. Urol., 2012, 61, 5, 1011-1018, doi: 10.1016/j.eururo.2012.01.008.
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Results
Schröder FH, Hugosson J, Carlsson S, Tammela T, Määttänen L, Auvinen A, Kwiatkowski M, Recker F, Roobol MJ, Screening for prostate cancer decreases the risk of developing metastatic disease: findings from the European Randomized Study of Screening for Prostate Cancer (ERSPC)., Eur. Urol., 2012, 62, 5, 745-752, doi: 10.1016/j.eururo.2012.05.068.
-
Results
Bokhorst LP, Bangma CH, van Leenders GJ, Lous JJ, Moss SM, Schröder FH, Roobol MJ, Prostate-specific antigen-based prostate cancer screening: reduction of prostate cancer mortality after correction for nonattendance and contamination in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer., Eur. Urol., 2014, 65, 2, 329-336, doi: 10.1016/j.eururo.2013.08.005.
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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, , Prostate-cancer mortality at 11 years of follow-up., N. Engl. J. Med., 2012, 366, 11, 981-990, doi: 10.1056/NEJMoa1113135.
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Results
Schröder FH, Hugosson J, Roobol MJ, Tammela TL, Zappa M, Nelen V, Kwiatkowski M, Lujan M, Määttänen L, Lilja H, Denis LJ, Recker F, Paez A, Bangma CH, Carlsson S, Puliti D, Villers A, Rebillard X, Hakama M, Stenman UH, Kujala P, Taari K, Aus G, Huber A, van der Kwast TH, van Schaik RH, de Koning HJ, Moss SM, Auvinen A; ERSPC Investigators, 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, 9959, 2027-2035, doi: 10.1016/S0140-6736(14)60525-0.