{"entity":{"id":"sthlm3-mri","kind":"trial","name":"STHLM3-MRI (Stockholm3 and MRI-targeted biopsy in prostate cancer screening)","aka":["STHLM3MR-2","STHLM3 MR Phase 2","Stockholm3-MRI"],"tldr":"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.","status":"positive","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT03377881","url":"https://clinicaltrials.gov/study/NCT03377881"},{"label":"Eklund et al., NEJM 2021","url":"https://doi.org/10.1056/NEJMoa2100852"},{"label":"Palsdottir et al., two-year follow-up, Annals of Internal Medicine 2026","url":"https://doi.org/10.7326/ANNALS-25-04753"}],"tags":[],"related":[],"cancers":["prostate"],"sections":["early-detection"],"technologies":["prostate-screening-psa-mri","mp-mri"],"targets":[],"drugs":[],"companies":[],"institutions":["karolinska","capio-st-goran"],"pathways":[],"terms":["psa","overdiagnosis"],"trials":[],"people":["martin-eklund","henrik-gronberg"],"bottlenecks":["b-early-detection"],"keyPapers":["paper-eklund-sthlm3-mri-nejm-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03377881","phase":"not-applicable","design":"non-inferiority","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","result":"Clinically significant cancer 21% (MRI-guided) vs 18% (standard biopsy), non-inferior; clinically insignificant cancer 4% vs 12%.","started":"2018-04-04","startedType":"actual","yearReported":2021,"enrolled":12750,"enrolledBasis":"registry","outcomes":[{"endpoint":"Clinically significant prostate cancer (Gleason 7 or more) detected","primary":true,"unit":"%","arms":[{"name":"MRI with targeted and standard biopsy","n":929,"value":21},{"name":"Standard biopsy","n":603,"value":18}],"source":"https://doi.org/10.1056/NEJMoa2100852"},{"endpoint":"Clinically insignificant prostate cancer (Gleason 6) detected","unit":"%","arms":[{"name":"MRI with targeted and standard biopsy","n":929,"value":4},{"name":"Standard biopsy","n":603,"value":12}],"source":"https://doi.org/10.1056/NEJMoa2100852"}]},"route":"/trials/sthlm3-mri/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"mp-mri","kind":"technology","name":"Multiparametric prostate MRI (PI-RADS)","route":"/technologies/mp-mri/"},{"id":"prostate-screening-psa-mri","kind":"technology","name":"PSA and MRI-first prostate cancer screening","route":"/technologies/prostate-screening-psa-mri/"}],"institution":[{"id":"capio-st-goran","kind":"institution","name":"Capio S:t Göran's Hospital","route":"/institutions/capio-st-goran/"},{"id":"karolinska","kind":"institution","name":"Karolinska University Hospital","route":"/institutions/karolinska/"}],"term":[{"id":"overdiagnosis","kind":"term","name":"Overdiagnosis","route":"/terms/overdiagnosis/"},{"id":"psa","kind":"term","name":"PSA (prostate-specific antigen)","route":"/terms/psa/"}],"person":[{"id":"henrik-gronberg","kind":"person","name":"Henrik Grönberg","route":"/people/henrik-gronberg/"},{"id":"martin-eklund","kind":"person","name":"Martin Eklund","route":"/people/martin-eklund/"}],"bottleneck":[{"id":"b-early-detection","kind":"bottleneck","name":"The hardest cancers are found late","route":"/bottlenecks/b-early-detection/"}],"paper":[{"id":"paper-eklund-sthlm3-mri-nejm-2021","kind":"paper","name":"MRI-targeted or standard biopsy in prostate cancer screening (STHLM3-MRI)","route":"/key-papers/paper-eklund-sthlm3-mri-nejm-2021/"},{"id":"paper-gronberg-sthlm3-lancet-oncol-2015","kind":"paper","name":"Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study","route":"/key-papers/paper-gronberg-sthlm3-lancet-oncol-2015/"}]}}