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ISRCTN
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ISRCTN54449243
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ClinicalTrials.gov identifier
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Public title
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The Göteborg randomised population based prostate cancer screening trial
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Prostate specific antigen (PSA) screening decreases prostate cancer mortality by 40% after 15 years.
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Lay summary
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Ethics approval
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Ethical Review Committee at the University of Göteborg approved in 1994
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Study design
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Population-based randomised controlled trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Prostate cancer
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Participants - inclusion criteria
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Men born during 1930 through 1944 living in the city of Göteborg, Sweden
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/1995
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Anticipated end date
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31/12/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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20,000 randomised
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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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.
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Sources of funding
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1. Swedish Cancer Society (Sweden) (ref: 090107, 080315 and 083455)
2. Swedish Medical Research Council (Sweden) (ref: 20095)
3. National Cancer Institute (USA) (ref: R21-CA127768-01A1)
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Trial website
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http://media.erspc-media.org/sweden/
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Publications
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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
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Contact name
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Prof
Jonas
Hugosson
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Address
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Bruna Stråket 11B
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City/town
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Göteborg
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Zip/Postcode
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SE-41345
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Country
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Sweden
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Sponsor
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Sahlgrenska University Hospital (Sweden)
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Address
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Östra
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City/town
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Göteborg
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Zip/Postcode
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SE-41345
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Country
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Sweden
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Sponsor website:
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http://www.sahlgrenska.se
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Date applied
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22/06/2010
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Last edited
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13/09/2010
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Date ISRCTN assigned
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29/06/2010
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