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European Randomised study of Screening for Prostate Cancer
DOI 10.1186/ISRCTN49127736
ClinicalTrials.gov identifier
EudraCT number
Public title European Randomised study of Screening for Prostate Cancer
Scientific title
Acronym ERSPC
Serial number at source NTR156
Study hypothesis Screening causes a difference in prostate cancer mortality of 20% or more.
Lay summary Not provided at time of registration
Ethics approval Local medical ethics committee gave approval
Study design Multicentre randomised active controlled parallel group trial
Countries of recruitment Belgium, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland
Disease/condition/study domain Prostate cancer
Participants - inclusion criteria Males aged 55 - 74 years (including age 74)
Participants - exclusion criteria Previous diagnosis of prostate cancer
Anticipated start date 01/10/1991
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material
Target number of participants 251133
Interventions Prostate Specific Antigen (PSA) determination followed by Digital Rectal Examination (DRE) and prostate biopsy if PSA greater than or equal to 3.
Primary outcome measure(s) Prostate cancer mortality compared between the screened and the non-screened group of men at risk.
Secondary outcome measure(s) 1. Progression-free (tumour free) survival
2. Survival free of metastatic disease
3. Quality of life in the screened and non-screened populations
Sources of funding 1. The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
2. European Union (EU) (Belgium) - Fifth and Sixth Framework Programmes (FP5, FP6)
3. The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
Trial website http://www.erspc.org
Publications 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
Contact name Mrs  M.  Roobol
  Address Erasmus Medical Center
Department of Urology
P.O. Box 2040
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Tel +31 (0)10 4634548
  Fax +31 (0)10 4635315
  Email m.roobol@erasmusmc.nl
Sponsor Erasmus Medical Centre (Netherlands)
  Address Dr Molewaterplein 40/50
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Sponsor website: http://www.erasmusmc.nl/
Date applied 20/12/2005
Last edited 01/10/2014
Date ISRCTN assigned 20/12/2005
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