{"entity":{"id":"promis","kind":"trial","name":"PROMIS","aka":["PROstate MRI Imaging Study","ISRCTN16082556"],"tldr":"The British study that measured how bad the standard prostate biopsy really was, and how good a scan could be instead: the evidence that put MRI before the needle in the NHS.","summary":"PROMIS gave 576 men all three tests and compared each against a 5 mm template mapping biopsy taken through the perineum, which is as close to ground truth as a living prostate allows. Defining clinically significant cancer as Gleason 4+3 or worse, or a maximum cancer core length of 6 mm or more, 408 of 576 men (71 percent) had cancer and 230 (40 percent) had clinically significant cancer.\n\nMultiparametric MRI had a sensitivity of 93 percent (95 percent confidence interval 88 to 96) against 48 percent (42 to 55) for transrectal biopsy; the trade was specificity, 41 percent (36 to 46) against 96 percent (94 to 98). Used as a triage test, MRI would let 27 percent of men avoid a primary biopsy altogether, diagnose 5 percent fewer clinically insignificant cancers, and detect up to 18 percent more clinically significant cancers if the biopsies that followed were MRI-directed. Forty-four of 740 men (5.9 percent) had a serious adverse event, including eight cases of sepsis: the harm the scan is there to avoid. NICE NG131 recommendation 1.2.2 now makes multiparametric MRI the first-line investigation for suspected clinically localised prostate cancer, reported on a five-point Likert scale, and box 1 of the guideline quotes PROMIS by name for the numbers a man needs when deciding whether to have a biopsy after a Likert 1 or 2 scan.","status":"positive","asOf":"2026-09-25","links":[{"label":"Lancet 2017","url":"https://europepmc.org/article/MED/28110982"},{"label":"ISRCTN16082556","url":"https://www.isrctn.com/ISRCTN16082556"}],"tags":["uk","prostate","diagnostics"],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":["diagnostics","early-detection"],"technologies":["mri"],"targets":[],"drugs":[],"companies":[],"institutions":["uclh","imperial-cancer-centre"],"pathways":[],"terms":["psa","biopsy"],"trials":[],"people":["hashim-ahmed","mark-emberton","caroline-moore"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN16082556","phase":"observational","setting":"Men with a raised PSA who had never had a biopsy, at eleven UK centres: a paired-cohort validating confirmatory study in which every man had a 1.5-tesla multiparametric MRI, a standard transrectal biopsy and a 5 mm transperineal template mapping biopsy as the reference standard, each read blind to the others; recruiting May 2012 to November 2015","sponsor":"University College London, funded by the NIHR Health Technology Assessment Programme (project 09/22/67)","result":"Multiparametric MRI sensitivity 93 percent against 48 percent for transrectal biopsy, at the cost of specificity (41 against 96 percent); as a triage test it would spare 27 percent of men a biopsy and find up to 18 percent more clinically significant cancers.","yearReported":2017,"enrolled":740,"enrolledBasis":"registered","enrolledNote":"740 men were enrolled and 576 completed all three tests: multiparametric MRI, transrectal ultrasound-guided biopsy and template prostate mapping biopsy.","outcomes":[]},"route":"/trials/promis/","neighbours":{"cancer":[{"id":"prostate-intermediate-risk","kind":"cancer","name":"Localised prostate cancer, intermediate risk","route":"/cancers/prostate-intermediate-risk/"},{"id":"prostate-low-risk","kind":"cancer","name":"Localised prostate cancer, very low and low risk","route":"/cancers/prostate-low-risk/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"mri","kind":"technology","name":"MRI","route":"/technologies/mri/"}],"institution":[{"id":"imperial-cancer-centre","kind":"institution","name":"Imperial College Healthcare NHS Trust / Imperial College London Cancer Research","route":"/institutions/imperial-cancer-centre/"},{"id":"uclh","kind":"institution","name":"University College London Hospitals / UCL Cancer Institute","route":"/institutions/uclh/"}],"term":[{"id":"biopsy","kind":"term","name":"Biopsy","route":"/terms/biopsy/"},{"id":"psa","kind":"term","name":"PSA (prostate-specific antigen)","route":"/terms/psa/"}],"person":[{"id":"caroline-moore","kind":"person","name":"Caroline Moore","route":"/people/caroline-moore/"},{"id":"hashim-ahmed","kind":"person","name":"Hashim U. Ahmed","route":"/people/hashim-ahmed/"},{"id":"mark-emberton","kind":"person","name":"Mark Emberton","route":"/people/mark-emberton/"}]}}