Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT 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
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
Trial setting
Hospitals
Trial 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
Phase
Not Applicable
Drug names
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 trial start date
01/01/1995
Overall trial 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
Patient
Age group
Adult
Gender
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
Trial 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
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
foundation
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)
NCI
Funding Body Type
private sector organisation
Funding Body Subtype
Research institutes and centers
Location
United States of America
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. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15042673
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17643983
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20598634
Publication citations
-
Results
Hugosson J, Aus G, Lilja H, Lodding P, Pihl CG, Results of a randomized, population-based study of biennial screening using serum prostate-specific antigen measurement to detect prostate carcinoma., Cancer, 2004, 100, 7, 1397-1405, doi: 10.1002/cncr.20126.
-
Results
Carlsson S, Aus G, Wessman C, Hugosson J, Anxiety associated with prostate cancer screening with special reference to men with a positive screening test (elevated PSA) - Results from a prospective, population-based, randomised study., Eur. J. Cancer, 2007, 43, 14, 2109-2116, doi: 10.1016/j.ejca.2007.06.002.
-
Results
Hugosson J, Carlsson S, Aus G, Bergdahl S, Khatami A, Lodding P, Pihl CG, Stranne J, Holmberg E, Lilja H, Mortality results from the Göteborg randomised population-based prostate-cancer screening trial., Lancet Oncol., 2010, 11, 8, 725-732, doi: 10.1016/S1470-2045(10)70146-7.