Plain English Summary
Not provided at time of registration
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The 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
Acronym
Study hypothesis
Prostate 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
Study design
Population-based randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prostate cancer
Intervention
Men 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 type
Other
Primary outcome measure
Prostate 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 measures
1. 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 date
01/01/1995
Overall study end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Men born during 1930 through 1944 living in the city of Göteborg, Sweden
Participant type(s)
Patient
Age group
Adult
Sex
Male
Target number of participants
20,000 randomised
Participant exclusion criteria
1. 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 date
01/01/1995
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Sweden
Study participating centre
Bruna Stråket 11B
Göteborg
SE-41345
Sweden
Sponsor information
Organisation
Sahlgrenska University Hospital (Sweden)
Sponsor details
Östra
Göteborg
SE-41345
Sweden
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
Swedish Cancer Society (Sweden) (ref: 090107, 080315 and 083455)
Alternative name(s)
Swedish Cancer Society
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Sweden
Funder name
Swedish Medical Research Council (Sweden) (ref: 20095)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Cancer Institute (USA) (ref: R21-CA127768-01A1)
Alternative name(s)
Instituto Nacional del Cáncer, NCI
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |