Norrköping Randomised Controlled Trial of Prostate Cancer Screening
| ISRCTN | ISRCTN06342431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06342431 |
| Secondary identifying numbers | 92044 (Linköping, Sweden, 1987) |
- 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
Scientific
Department of Urology
Linköpings Universitetssjukhus
581 91 Linköping
Linköping
581 91
Sweden
| Phone | +46 (0)11 18 33 32 |
|---|---|
| varenhorst.eberhard@telia.com |
Study information
| Study design | Randomised Controlled Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Please contact Gabriel Sandblom [gabriel.sandblom@ki.se] to request a patient 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 | 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 study start date | 01/01/1987 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 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
581 91
Sweden
Sponsor information
Research Council of Southeast Sweden (Forskningsrådet i Sydöstra Sverige) (Sweden)
Research council
Research council
Forskningsrådet i Sydöstra Sverige
581 91 Linköping
Sweden
Linköping
581 91
Sweden
| Phone | +46 (0)13 22 76 55 |
|---|---|
| yvonne.h.jonsson@lio.se | |
"ROR" |
https://ror.org/0326gsy75 |
Funders
Funder type
Research council
The Research Council in the SouthEast Region of Sweden (Sweden) - (number F97-318)
No information available
The Swedish Cancer Foundation (Sweden)
No information available
County Council of Östergötland (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
