Clinical trial · Interventional
Long-term Outcomes of Prostate Cancer Screening
Long-term Outcomes of Prostate Cancer Screening Using PSA, Biomarkers and MRI: The STHLM3MRI Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and randomized to a single PSA test with prostate biopsies followed by opportunistic testing and (iii) population controls. Mortality is verified through register data, disease verification is made through in-study biopsy results and registry data.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSA | Diagnostic Test | — | UNRESOLVED |
| PSA/Stockholm3/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Organized screening including repeat testing (MRI+biomarkers)
- description
- 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
- interventionNames
- Diagnostic Test: PSA/Stockholm3/MRI
- type
- ACTIVE_COMPARATOR
- label
- One-time invitation to testing arm (traditional biopsies)
- description
- 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.
- interventionNames
- Diagnostic Test: PSA
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Eligible participants: -Men eligible for the longterm f/u-study arms (experimental and control) are participants in the STHLM3MRI trial. 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: * Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia * 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.
References
Publications (0)
Data not yet available