The Göteborg randomised population based prostate cancer screening trial

ISRCTN ISRCTN54449243
DOI https://doi.org/10.1186/ISRCTN54449243
Secondary identifying numbers N/A
Submission date
22/06/2010
Registration date
29/06/2010
Last edited
13/09/2010
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

Not provided at time of registration

Study website

Contact information

Prof Jonas Hugosson
Scientific

Bruna Stråket 11B
Göteborg
SE-41345
Sweden

Study information

Study designPopulation-based randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe Göteborg prostate cancer screening trial: a population-based randomised controlled trial of a screening group invited for biennial prostate specific antigen (PSA) testing versus a control group not invited
Study hypothesisProstate specific antigen (PSA) screening decreases prostate cancer mortality by 40% after 15 years.
Ethics approval(s)Ethical Review Committee at the University of Göteborg approved in 1994
ConditionProstate cancer
InterventionMen allocated to the screening arm are invited every second year for PSA testing, until they reach the upper age limit (70 years). Only men with PSA at or above the threshold (greater than or equal to 3 ng/mL) are invited for further urological work-up including digital rectal examination (DRE), transrectal ultrasound (TRUS) examination, and laterally directed sextant biopsies.

Men allocated to the control group will not be part of any planned intervention; the incidence of prostate cancer, stage, grade and primary treatment as well as cause of death will be registered in the control group.

Last invitaion to the study will be in 2014 but follow-up will continue for many more years. Last follow-up is not stated in the protocol as things may change during a 20-year study.
Intervention typeOther
Primary outcome measureProstate cancer specific mortality (absolute and relative risk reduction in cumulative prostate cancer mortality) analysed according to the intention-to-screen principle (comparing the screening group with the control group). Analysed at study completion (after 15 years).
Secondary outcome measures1. Cumulative prostate cancer incidence and the proportion of screening attendees
2. Comparisons of stage and age distribution
3. Lead and length time bias
4. Quality of life between screened men and controls

Analysed at study completion.
Overall study start date01/01/1995
Overall study end date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants20,000 randomised
Participant inclusion criteriaMen born during 1930 through 1944 living in the city of Göteborg, Sweden
Participant exclusion criteria1. Men with a prior diagnosis of prostate cancer
2. Men who had died or emigrated but had not been removed from the Population Register at time of randomisation
Recruitment start date01/01/1995
Recruitment end date31/12/2014

Locations

Countries of recruitment

  • Sweden

Study participating centre

Bruna Stråket 11B
Göteborg
SE-41345
Sweden

Sponsor information

Sahlgrenska University Hospital (Sweden)
Hospital/treatment centre

Östra
Göteborg
SE-41345
Sweden

Website http://www.sahlgrenska.se
ROR logo "ROR" https://ror.org/04vgqjj36

Funders

Funder type

Research organisation

Swedish Cancer Society (Sweden) (ref: 090107, 080315 and 083455)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Swedish Cancer Society
Location
Sweden
Swedish Medical Research Council (Sweden) (ref: 20095)

No information available

National Cancer Institute (USA) (ref: R21-CA127768-01A1)
Government organisation / National government
Alternative name(s)
Instituto Nacional del Cáncer, National Cancer Institute at the National Institutes of Health, Instituto Nacional del Cáncer de los Institutos Nacionales de la Salud, NCI
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2004 Yes No
Results article results 01/09/2007 Yes No
Results article results 01/08/2010 Yes No