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Norrköping Randomised Controlled Trial of Prostate Cancer Screening
ISRCTN ISRCTN06342431
DOI 10.1186/ISRCTN06342431
ClinicalTrials.gov identifier
EudraCT number
Public title Norrköping Randomised Controlled Trial of Prostate Cancer Screening
Scientific title Prostate screening for men aged 50-69 in Norrköping, Sweden: A twelve-year randomised controlled trial with twenty-year follow up
Acronym N/A
Serial number at source 92044 (Linköping, Sweden, 1987)
Study hypothesis Screening for prostate cancer is cost effective, well accepted and reduces prostate cancer mortality
Lay summary
Ethics approval Research Ethics Committee, Faculty of Health Sciences in Linkoping (forskningsetikkommittén, Hälsouniversitetet i Linköping) approved on the 8th of April 1992 (ref: 92044)
Study design Randomised Controlled Trial
Countries of recruitment Sweden
Disease/condition/study domain Prostate Cancer
Participants - inclusion criteria Men aged 50–69 years in 1987 residing in Norrköping, Sweden.
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/01/1987
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material Please contact Gabriel Sandblom [gabriel.sandblom@ki.se] to request a patient information sheet
Target number of participants 9000
Interventions 1494 men were randomly selected from a population of 9026 men aged 50-69 (the total male population of that age in the area).
Information was issued through local media and an invitation to screening sent to selected individuals.
Screening was conducted every third year from 1987-1996. Digital rectal examination only was performed in 1987 and 1990. PSA testing (cut-off level 4 ng/ml) was added in 1993 and 1996.
The total duration of follow up was 15-20 years.
Primary outcome measure(s) Prostate Cancer mortality, determined by obtaining data from the Swedish Central Death Register on date and cause of death. Cause of death was also checked in the South-East
Region Prostate Cancer Register.
Secondary outcome measure(s) 1. Cost effectiveness, determined when twelve year survival data were accessible
2. Acceptance, assessed by questionnaires immediately after the screening examinations
3. Diagnostic accuracy
Further information on the outcomes and methods of assessment may be found in the publications below.
Sources of funding 1. The Research Council in the South–East Region of Sweden (Sweden) - (number F97-318)
2. The Swedish Cancer Foundation (Sweden)
3. County Council of Östergötland (Sweden)
Trial website
Publications 1. 1990 results in http://www.ncbi.nlm.nih.gov/pubmed/2344514
2. 1990 results on cost effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/10113546
3. 1992 results in http://www.ncbi.nlm.nih.gov/pubmed/1290631
4. 1993 results in http://www.ncbi.nlm.nih.gov/pubmed/8402021
5. 2011 20 year follow up results in http://www.ncbi.nlm.nih.gov/pubmed/21454449
5. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15548438
Contact name Prof  Eberhard  Varenhorst
  Address Department of Urology
Linköpings Universitetssjukhus
581 91 Linköping
  City/town Linköping
  Zip/Postcode 581 91
  Country Sweden
  Tel +46 (0)11 18 33 32
  Email varenhorst.eberhard@telia.com
Sponsor Research Council of Southeast Sweden (Forskningsrådet i Sydöstra Sverige) (Sweden)
  Address Forskningsrådet i Sydöstra Sverige
581 91 Linköping
Sweden
  City/town Linköping
  Zip/Postcode 581 91
  Country Sweden
  Tel +46 (0)13 22 76 55
  Email yvonne.h.jonsson@lio.se
Date applied 26/04/2010
Last edited 26/05/2011
Date ISRCTN assigned 15/06/2010
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