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ISRCTN
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ISRCTN84445406
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DOI
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10.1186/ISRCTN84445406
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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STHLM3 - Prostate cancer diagnostic trial
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Scientific title
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STHLM3 - Prostate cancer diagnostic randomized trial
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Acronym
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STHLM3
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Serial number at source
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N/A
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Study hypothesis
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STHLM3 [STHLM relates to the city of Stockholm, Number 3 relates to that this is the third study within the same setting] is a randomized controlled trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for high risk prostate cancer.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Stockholm Ethical Review Board, 09 May 2012, ref: r DNR 2012/572-31/1
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Study design
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Two-armed randomized 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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All men between 50 and 69 years of age who have a permanent postal address in Stockholm County Council or Region Gotland (N=260,000) will be asked whether they would like to take part in STHLM3.
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Participants - exclusion criteria
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Diagnosed with prostate cancer
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Anticipated start date
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01/01/2013
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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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Patient information in Swedish can be found at http://sthlm3.se/dokument/
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Target number of participants
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140,000
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Interventions
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The two study arms will be:
Control/PSA arm, where referral to biopsy will be based on Prostate-specific antigen (PSA) only with PSA ≥ 3 as the level of referral to prostate biopsy
Intervention/Best biomarker panel (BBP) arm, where referral to biopsy will be determined by a risk prediction model based on age, an array of single-nucleotide polymorphism (SNPs), family history and protein-based biomarkers.
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Primary outcome measure(s)
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To increase the specificity of a combined prostate cancer test compared to the PSA test without decreasing the sensitivity of high risk of prostate cancers (defined as Gleason 7 or higher). The primary endpoint is number of prostate biopsies.
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Secondary outcome measure(s)
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1. To decrease the number of low risk prostate cancers diagnosed
2. To increase the health related quality of life and knowledge of prostate cancer testing
3. To assess the health economic consequences of implementing prostate cancer screening
4. To improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm
5. To assess the overall long-term mortality of prostate cancer in the Stockholm/Gotland area over a 10-15 year period
6. To assess the combination of a blood based “best biomarker panel” and urine biomarkers in men with initial negative prostate biopsy (separate study protocol STHLM3-Rebiopsy) and
7. To facilitate inclusion in active surveillance protocol in men diagnosed with low risk prostate cancers
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Sources of funding
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Stockholm County Council (Sweden)
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Trial website
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http://sthlm3.se
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Publications
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Contact name
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Prof
Henrik
Grönberg
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Address
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Nobels väg 12
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City/town
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Stockholm
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Zip/Postcode
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17177
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Country
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Sweden
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Sponsor
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Karolinska Institutet (Sweden)
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Address
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Department of Medical Epidemiology and Biostatistics
PO Box 281
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City/town
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Stockholm
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Zip/Postcode
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17177
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Country
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Sweden
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Sponsor website:
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http://ki.se/ki/jsp/polopoly.jsp?l=en&d=9600
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Date applied
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14/11/2012
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Last edited
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03/01/2013
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Date ISRCTN assigned
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03/01/2013
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