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ISRCTN
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ISRCTN49127736
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ClinicalTrials.gov identifier
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Public title
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European Randomised study of Screening for Prostate Cancer
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Scientific title
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Acronym
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ERSPC
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Serial number at source
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NTR156
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Study hypothesis
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Screening causes a difference in prostate cancer mortality of 20% or more.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Local medical ethics committee gave approval
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Study design
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Multicentre randomised active controlled parallel group trial
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Countries of recruitment
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Belgium, Finland, France, Italy, Netherlands, Spain, Sweden, Switzerland
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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Males aged 55 - 74 years (including age 74)
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Participants - exclusion criteria
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Previous diagnosis of prostate cancer
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Anticipated start date
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01/10/1991
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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251133
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Interventions
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Prostate Specific Antigen (PSA) determination followed by Digital Rectal Examination (DRE) and prostate biopsy if PSA greater than or equal to 3.
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Primary outcome measure(s)
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Prostate cancer mortality compared between the screened and the non-screened group of men at risk.
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Secondary outcome measure(s)
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1. Progression-free (tumour free) survival
2. Survival free of metastatic disease
3. Quality of life in the screened and non-screened populations
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Sources of funding
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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)
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Trial website
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http://www.erspc.org
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Publications
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1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19297566
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21601352
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22264679
4. 2012 11-year follow up in http://www.ncbi.nlm.nih.gov/pubmed/22417251
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Contact name
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Mrs
M.
Roobol
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Address
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Erasmus Medical Center
Department of Urology
P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Tel
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+31 (0)10 4634548
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Fax
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+31 (0)10 4635315
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Email
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m.roobol@erasmusmc.nl
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Sponsor
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Erasmus Medical Centre (Netherlands)
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Address
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Dr Molewaterplein 40/50
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Sponsor website:
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http://www.erasmusmc.nl/
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Date applied
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20/12/2005
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Last edited
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22/03/2012
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Date ISRCTN assigned
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20/12/2005
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