Condition category
Cancer
Date applied
26/04/2010
Date assigned
15/06/2010
Last edited
26/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eberhard Varenhorst

ORCID ID

Contact details

Department of Urology
Linköpings Universitetssjukhus
581 91 Linköping
Linköping
581 91
Sweden
+46 (0)11 18 33 32
varenhorst.eberhard@telia.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

92044 (Linköping, Sweden, 1987)

Study information

Scientific title

Prostate screening for men aged 50-69 in Norrköping, Sweden: A twelve-year randomised controlled trial with twenty-year follow up

Acronym

Study hypothesis

Screening for prostate cancer is cost effective, well accepted and reduces prostate cancer mortality

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Please contact Gabriel Sandblom [gabriel.sandblom@ki.se] to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measure

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 measures

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.

Overall trial start date

01/01/1987

Overall trial end date

31/12/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Men aged 50–69 years in 1987 residing in Norrköping, Sweden.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

9000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/1987

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Urology
Linköping
581 91
Sweden

Sponsor information

Organisation

Research Council of Southeast Sweden (Forskningsrådet i Sydöstra Sverige) (Sweden)

Sponsor details

Forskningsrådet i Sydöstra Sverige
581 91 Linköping
Sweden
Linköping
581 91
Sweden
+46 (0)13 22 76 55
yvonne.h.jonsson@lio.se

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

The Research Council in the South–East Region of Sweden (Sweden) - (number F97-318)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Cancer Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

County Council of Östergötland (Sweden)

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

Basic results (scientific)

Publication list

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

Publication citations

  1. Results

    Pedersen KV, Carlsson P, Varenhorst E, Löfman O, Berglund K, Screening for carcinoma of the prostate by digital rectal examination in a randomly selected population., BMJ, 1990, 300, 6731, 1041-1044.

  2. Results

    Sandblom G, Varenhorst E, Löfman O, Rosell J, Carlsson P, Clinical consequences of screening for prostate cancer: 15 years follow-up of a randomised controlled trial in Sweden., Eur. Urol., 2004, 46, 6, 717-23; discussion 724, doi: 10.1016/j.eururo.2004.08.011.

  3. Carlsson P, Pedersen KV, Varenhorst E, Costs and benefits of early detection of prostatic cancer., Health Policy, 1990, 16, 3, 241-253.

  4. Varenhorst E, Carlsson P, Capik E, Löfman O, Pedersen KV, Repeated screening for carcinoma of the prostate by digital rectal examination in a randomly selected population., Acta Oncol, 1992, 31, 8, 815-821.

  5. Varenhorst E, Berglund K, Löfman O, Pedersen K, Inter-observer variation in assessment of the prostate by digital rectal examination., Br J Urol, 1993, 72, 2, 173-176.

  6. Sandblom G, Varenhorst E, Rosell J, Löfman O, Carlsson P, Randomised prostate cancer screening trial: 20 year follow-up., BMJ, 2011, 342, d1539.

Additional files

Editorial Notes