Every man with a raised PSA used to get a needle biopsy through the rectum, which misses half the serious cancers and can cause sepsis. This trial gave 576 men a scan, a standard biopsy and an exhaustive mapping biopsy, and showed the scan could safely spare a quarter of them the needle.
Hashim Ahmed, Mark Emberton and the PROMIS study group ran a paired-cohort confirmatory study in which men with prostate-specific antigen up to 15 nanograms per millilitre and no previous biopsy had 1.5 Tesla multiparametric magnetic resonance imaging, then both transrectal ultrasound-guided biopsy and template prostate mapping biopsy as the reference standard, each read blind to the others.
The design is the point. Comparing a scan against the biopsy it is meant to replace tells you nothing, because the biopsy is itself inaccurate; PROMIS compared both against an exhaustive mapping biopsy. The result, that the scan is far more sensitive and far less specific than the standard biopsy, is what made magnetic resonance imaging a triage test rather than a confirmatory one, and PRECISION the following year showed the pathway works in practice.
The evidence that put a scan in front of the biopsy. It reduces the number of men who are biopsied at all, reduces the number of harmless cancers found, and increases the number of dangerous ones, which is the only combination that improves a screening pathway on both sides at once.
This is the paper Europe PMC returns for registry id ISRCTN94604465 with the most citations, so it is the natural first reading for anyone following the trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
The limit of what a prostate scan can be asked to do. It is a good triage test for whether to biopsy and a poor map of where every tumour is, which matters for anyone being offered treatment to part of the gland or follow-up by imaging alone.
Pre-biopsy MRI with targeted sampling is now the standard diagnostic pathway for suspected prostate cancer, reducing overdiagnosis of low-risk disease.
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