Clinical trial · Interventional
Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
STHLM3 MR Phase 2: A New Diagnostic Chain for Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
NCT03377881CI-TRIAL-00072515STHLM3MR-2active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The STHLM3-MRI trial is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context. The study includes individualised repeat invitations for re-screening to participants not diagnosed with prostate cancer.
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 |
|---|---|---|---|
| MRI/Fusion biopsies | Procedure | — | UNRESOLVED |
| Systematic biopsies | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard arm (One testing with PSA and standard biopsy)
- description
- The traditional/control arm consists of PSA testing and if PSA\>3ng/ml a systematic biopsy of the prostate is performed. Only one screening is offered for participants.
- interventionNames
- Procedure: Systematic biopsies
- type
- EXPERIMENTAL
- label
- STHLM3+MRI/Fusion including repeat screening.
- description
- The experimental arm consists of a Stockholm3 bloodiest and if elevated, an MRI is recommended with targeted biopsies to prostate lesions. Participants with PSA\<1.5ng/ml are reinvented for prescreen after 6 years. Remaining participants with no prostate cancer detected are reinvited for re-screen at 2-3 years.
- interventionNames
- Procedure: MRI/Fusion biopsies
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Permanent postal address in Stockholm 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.
References
Publications (8)
- BACKGROUNDNordstrom T, Picker W, Aly M, Jaderling F, Adolfsson J, Strom P, Haug ES, Eklund M, Carlsson S, Gronberg H. Detection of Prostate Cancer Using a Multistep Approach with Prostate-specific Antigen, the Stockholm 3 Test, and Targeted Biopsies: The STHLM3 MRI Project. Eur Urol Focus. 2017 Dec;3(6):526-528. doi: 10.1016/j.euf.2017.01.014. Epub 2017 Mar 28. PMID 28753850
- RESULTNordstrom T, Discacciati A, Bergman M, Clements M, Aly M, Annerstedt M, Glaessgen A, Carlsson S, Jaderling F, Eklund M, Gronberg H; STHLM3 study group. Prostate cancer screening using a combination of risk-prediction, MRI, and targeted prostate biopsies (STHLM3-MRI): a prospective, population-based, randomised, open-label, non-inferiority trial. Lancet Oncol. 2021 Sep;22(9):1240-1249. doi: 10.1016/S1470-2045(21)00348-X. Epub 2021 Aug 13. PMID 34391509
- RESULTEklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9. PMID 34237810
- DERIVEDPalsdottir T, Micoli C, Eklund M, Gronberg H, Jaderling F, Tilki D, Lin DW, Cooperberg MR, Eggener SE, Oeffinger KC, Nordstrom T, Vigneswaran HT. Stockholm3-Magnetic Resonance Imaging Population-Based Prostate Cancer Screening Study: Two-Year Follow-up. Ann Intern Med. 2026 Jul;179(7):988-995. doi: 10.7326/ANNALS-25-04753. Epub 2026 Jun 23. PMID 42330502
- DERIVEDBjornebo L, Discacciati A, Falagario U, Vigneswaran HT, Jaderling F, Gronberg H, Eklund M, Nordstrom T, Lantz A. Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247131. doi: 10.1001/jamanetworkopen.2024.7131. PMID 38648061
- DERIVEDNordstrom T, Annerstedt M, Glaessgen A, Carlsson S, Clements M, Abbadi A, Gronberg H, Jaderling F, Eklund M, Discacciati A. Repeated Prostate Cancer Screening Using Prostate-Specific Antigen Testing and Magnetic Resonance Imaging: A Secondary Analysis of the STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2354577. doi: 10.1001/jamanetworkopen.2023.54577.