# STHLM3-MRI (Stockholm3 and MRI-targeted biopsy in prostate cancer screening)

Source: https://onco.cc/trials/sthlm3-mri/  
OnCo record `sthlm3-mri` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Stockholm trial that invited men from the general population for prostate testing and asked whether using an MRI scan to decide who needs a biopsy finds as many important cancers as biopsying everyone with a raised PSA. It did, and it found about a third as many harmless cancers.

## Summary

STHLM3-MRI enrolled 12,750 men aged 50 to 74 invited by post from the general population. The 1,532 with a PSA of 3 ng/mL or higher were randomised 2:3 to a standard biopsy (603) or to MRI followed by targeted and standard biopsy only if the scan suggested cancer (929). In the intention-to-treat analysis clinically significant cancer (Gleason score 7 or more) was found in 21 per cent of the MRI group and 18 per cent of the standard group, meeting the non-inferiority margin, while clinically insignificant cancer fell from 12 to 4 per cent. The trial also tested the Stockholm3 blood-based risk score, developed in the earlier STHLM3 study, and a two-year follow-up of the baseline round was published in 2026. It was funded by the Swedish Research Council and others.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-11-03
- Also known as: STHLM3MR-2; STHLM3 MR Phase 2; Stockholm3-MRI
- Registry id: NCT03377881
- Phase: not-applicable
- Setting: Population-based prostate cancer screening by invitation of men aged 50 to 74 in Stockholm: men with PSA of 3 ng/mL or more randomised 2:3 to standard biopsy or MRI with targeted and standard biopsy
- Sponsor: Karolinska Institutet
- Enrolled: 12750
- Result: Clinically significant cancer 21% (MRI-guided) vs 18% (standard biopsy), non-inferior; clinically insignificant cancer 4% vs 12%.
- Outcomes: Clinically significant prostate cancer (Gleason 7 or more) detected: MRI with targeted and standard biopsy 21% vs Standard biopsy 18%; Clinically insignificant prostate cancer (Gleason 6) detected: MRI with targeted and standard biopsy 4% vs Standard biopsy 12%

## Sources

- ClinicalTrials.gov NCT03377881: https://clinicaltrials.gov/study/NCT03377881
- Eklund et al., NEJM 2021: https://doi.org/10.1056/NEJMoa2100852
- Palsdottir et al., two-year follow-up, Annals of Internal Medicine 2026: https://doi.org/10.7326/ANNALS-25-04753

## Connected records

- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [Multiparametric prostate MRI (PI-RADS)](https://onco.cc/technologies/mp-mri/), [PSA and MRI-first prostate cancer screening](https://onco.cc/technologies/prostate-screening-psa-mri/)
- institutions: [Capio S:t Göran's Hospital](https://onco.cc/institutions/capio-st-goran/), [Karolinska University Hospital](https://onco.cc/institutions/karolinska/)
- terms: [Overdiagnosis](https://onco.cc/terms/overdiagnosis/), [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/)
- people: [Henrik Grönberg](https://onco.cc/people/henrik-gronberg/), [Martin Eklund](https://onco.cc/people/martin-eklund/)
- bottlenecks: [The hardest cancers are found late](https://onco.cc/bottlenecks/b-early-detection/)
- key papers: [MRI-targeted or standard biopsy in prostate cancer screening (STHLM3-MRI)](https://onco.cc/key-papers/paper-eklund-sthlm3-mri-nejm-2021/), [Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study](https://onco.cc/key-papers/paper-gronberg-sthlm3-lancet-oncol-2015/)

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