Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
7500 participants
INTERVENTIONAL
2024-11-01
2035-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Organized screening including repeat testing (MRI+biomarkers)
participants are offered prostate cancer screening. Interventions are (i) a paired PSA and Stockholm3 bloodtest; (ii) if elevated (PSA\>=3 \| Stockholm3\>=0.11), an MRI is offered. If MRI shows PI-RADS≥3, prostate biopsies are offered. Screenings are offered at year 0, year 2-3 (if original PSA≥1.5) and year 6
PSA/Stockholm3/MRI
Stockholm3+PSA followed by MRI of the prostate
One-time invitation to testing arm (traditional biopsies)
participants are offered prostate cancer screening. interventions are a PSA bloodtest. If PSA≥3 ng/ml, a standard prostate biopsy is offered. No repeat screenings are offered.
PSA
PSA followed by standard biopsies
Population controls
Population controls are identified through registers and followed in national outcome registers (Swedish Board of Health and Welfare)
No interventions assigned to this group
Interventions
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PSA/Stockholm3/MRI
Stockholm3+PSA followed by MRI of the prostate
PSA
PSA followed by standard biopsies
Eligibility Criteria
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Inclusion Criteria
* Men age 50-74 years without prior diagnosis of prostate cancer (ICD-9 C61).
* Permanent postal address in Stockholm
* Not a previous participant in the Stockholm3 study (2012-2014)
Exclusion Criteria
* Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
* Men with a previous prostate biopsy the preceding 60 days before invitation.
50 Years
74 Years
MALE
Yes
Sponsors
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Swedish Cancer Foundation
OTHER
The Swedish Research Council
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Tobias Nordström
Associate Professor, Consultant Urologist
Principal Investigators
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Tobias Nordström, Ass Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institutet
Stockholm, , Sweden
Countries
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Other Identifiers
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STHLM3MRI_3
Identifier Type: -
Identifier Source: org_study_id
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