# PROMIS

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

## TL;DR

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.

Multiparametric 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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: PROstate MRI Imaging Study; ISRCTN16082556
- Tags: uk; prostate; diagnostics
- Registry id: 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)
- Enrolled: 740
- 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.

## Sources

- Lancet 2017: https://europepmc.org/article/MED/28110982
- ISRCTN16082556: https://www.isrctn.com/ISRCTN16082556

## Connected records

- cancers: [Localised prostate cancer, intermediate risk](https://onco.cc/cancers/prostate-intermediate-risk/), [Localised prostate cancer, very low and low risk](https://onco.cc/cancers/prostate-low-risk/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [MRI](https://onco.cc/technologies/mri/)
- institutions: [Imperial College Healthcare NHS Trust / Imperial College London Cancer Research](https://onco.cc/institutions/imperial-cancer-centre/), [University College London Hospitals / UCL Cancer Institute](https://onco.cc/institutions/uclh/)
- terms: [Biopsy](https://onco.cc/terms/biopsy/), [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/)
- people: [Caroline Moore](https://onco.cc/people/caroline-moore/), [Hashim U. Ahmed](https://onco.cc/people/hashim-ahmed/), [Mark Emberton](https://onco.cc/people/mark-emberton/)

---
JSON: https://onco.cc/api/v1/entities/promis.json