UNASSIGNED: 62 Background: Over 1 million US men undergo prostate biopsy each year. About two thirds will test negative. This negative status is uncertain as up to a quarter will have @entity263 on repeat biopsy. Further, a positive result often fails to discriminate clinically significant from insignificant disease. PROMIS will investigate whether multi-parametric MRI (mpMRI) can discriminate between men with no @entity5 or clinically insignificant @entity5 versus those with clinically significant @entity5 , using template prostate mapping (TPM) biopsies as the most accurate and appropriate reference test in men referred for biopsy. METHODS: PROMIS is a multicenter, validating paired cohort study designed to include up to 714 men who will have an mpMRI (index test) and, under general anaesthetic, undergo 10-12 core TRUS biopsy (standard test) and TPM with sampling every 5mm throughout the prostate (reference test). All tests will be assessed independently. Clinically significant @entity5 on TPM is defined as dominant Gleason pattern >= 4 and/or @entity5 core length of >= 6mm. PROMIS is powered to measure an absolute increase in sensitivity from 48%, on TRUS biopsy, to at least 70%, by mpMRI. RESULTS: The study will report the proportion of men (i) who could safely avoid biopsy and (ii) correctly identified by mpMRI to have clinically significant @entity263 . mpMRI will be assessed using an ordinal score of 1 to 5 (highly likely benign - highly likely malignant), with a score >= 3 indicating a positive mpMRI for presence of clinically significant @entity5 . Secondary objectives will include outcomes based on another definition of clinically significant @entity5 (non-dominant Gleason pattern >= 4 and/or @entity5 core length >= 4mm), and cost-effectiveness of using mpMRI prior to biopsy. CONCLUSIONS: PROMIS will provide level 1 evidence by comparing mpMRI with the current standard, TRUS biopsy, using an accurate reference test that can be applied to all men advised to have a biopsy. If successful, mpMRI could in the future allow between a quarter and a half of US men referred to safely avoid a biopsy and/or improve the detection of clinically significant @entity5 by 20%.

Multiparametric magnetic resonance imaging in the diagnosis and characterisation of XXXX : The PROMIS study.

@entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity263 :: ('MESH:D011471', 'Disease') :: ['prostate cancer']
@entity263 :: (MESH:D011471,Disease) :: ['prostate cancer']
