Norrköping Randomised Controlled Trial of Prostate Cancer Screening

ISRCTN	ISRCTN06342431
DOI	https://doi.org/10.1186/ISRCTN06342431
Protocol serial number	92044 (Linköping, Sweden, 1987)
Sponsor	Research Council of Southeast Sweden (Forskningsrådet i Sydöstra Sverige) (Sweden)
Funders	The Research Council in the SouthEast Region of Sweden (Sweden) - (number F97-318), The Swedish Cancer Foundation (Sweden), County Council of Östergötland (Sweden)

Submission date: 26/04/2010
Registration date: 15/06/2010
Last edited: 26/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eberhard Varenhorst
Scientific

Department of Urology
Linköpings Universitetssjukhus
581 91 Linköping
Linköping
581 91
Sweden

Phone	+46 (0)11 18 33 32
Email	varenhorst.eberhard@telia.com

Study information

Primary study design	Interventional
Study design	Randomised Controlled Trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Prostate screening for men aged 50-69 in Norrköping, Sweden: A twelve-year randomised controlled trial with twenty-year follow up
Study objectives	Screening for prostate cancer is cost effective, well accepted and reduces prostate cancer mortality
Ethics approval(s)	Research Ethics Committee, Faculty of Health Sciences in Linkoping (forskningsetikkommittén, Hälsouniversitetet i Linköping) approved on the 8th of April 1992 (ref: 92044)
Health condition(s) or problem(s) studied	Prostate Cancer
Intervention	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.
Intervention type	Other
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.
Key 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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	9000
Key inclusion criteria	Men aged 5069 years in 1987 residing in Norrköping, Sweden.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/1987
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Urology

Linköping
581 91
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/04/1990		Yes	No
Results article	results on cost effectiveness	01/12/1990		Yes	No
Results article	results	01/12/1992		Yes	No
Results article	results	01/08/1993		Yes	No
Results article	results	01/12/2004		Yes	No
Results article	20 year follow up results	31/03/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes