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NCT06573736: S3M-MRI
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation
trial testing Stockholm3 in Prostate Cancer in 500 participants. Not yet recruiting.
1 December 2025
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 October 2024 |
| Primary completion | 1 December 2025 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- Stockholm3
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Karolinska Institutet
Who can join
Adults 40 to 80, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Men meeting local clinical standard of care to undergo a prostate MRI for suspicion of prostate cancer will be included. Blood sample will be drawn on the day of MRI or immediately prior to MRI for measurement of the prostate cancer biomarker Stockholm3. Specifically, the Stockholm3 test will be performed in a retrospective manner and no clinical decisions will be made based on the results. The patients will not receive the results of the Stockholm3 assay. A Stockholm3 score will be reported for each patient. The primary aim is to show superior specificity of Stockholm3 (at different thresholds) for MRI selection compared to PSA (at different thresholds) (I.e., the proportion of men with a negative Stockholm3 test or a negative PSA test among those with a normal MRI). Additional aims: 1. To show non-inferior relative sensitivity in detection of csPC of Stockholm3 compared to PSA (The proportion of men with a positive Stockholm3 test (at different thresholds) or a positive PSA test (at different thresholds) among those diagnosed with csPC will be calculated). 2. To evaluate Stockholm3 risk thresholds to determine if it can be used to further reduce MRI, biopsy and Gleason grade group 1 cancers without reducing sensitivity of csPC detection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06573736
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Stockholm3
Trials testing the same drug.
- NCT07478536 — Stockholm3 Test Validation in Men on Active Surveillance in Switzerland (CHAS3 Trial) · not yet recruiting
- NCT05294627 — Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss Population · completed
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
- NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06573736 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 27 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06573736.
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