Background: Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multiparametric\nMRI (MP-MRI) may improve the diagnostic pathway.\nMethods: PROMIS is a prospective validating paired-cohort study that meets criteria for level 1\nevidence in diagnostic test evaluation. PROMIS will investigate whether multi-parametric (MP)-\nMRI can discriminate between men with and without clinically-significant prostate cancer who\nare at risk prior to first biopsy. Up to 714men will have MP-MRI (index), 10ââ?¬â??12 core TRUS-biopsy\n(standard) and 5 mm transperineal template mapping (TPM) biopsies (reference). The conduct\nand reporting of each test will be blinded to the others.\nResults: PROMIS will measure and compare sensitivity, specificity, and positive and negative\npredictive values of bothMP-MRI and TRUS-biopsy against TPMbiopsies. The MP-MRI resultswill\nbe used to determine the proportion ofmenwho could safely avoid biopsywithout compromising\ndetection of clinically-significant cancers. For the primary outcome, significant cancer on TPM is\ndefined as Gleason grade N/= 4 + 3 and/or maximum cancer core length of ?6 mm. PROMIS\nwill also assess inter-observer variability among radiologists among other secondary outcomes.\nCost-effectiveness of MP-MRI prior to biopsy will also be evaluated.\nConclusions: PROMIS will determine whether MP-MRI of the prostate prior to first biopsy\nimproves the detection accuracy of clinically-significant cancer.
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