The PROMIS study: A paired-cohort, blinded confirmatory study evaluating the accuracy of multi-parametric MRI and TRUS biopsy in men with an elevated PSA.

5000Background: Multi-parametric magnetic resonance imaging (MP-MRI) as a triage test might allow men to avoid unnecessary transrectal ultrasound-guided (TRUS) prostate biopsy since many men with an elevated PSA do not have clinically significant prostate cancer. Methods: PROMIS (ClinicalTrials.gov/NCT01292291) is a prospective, paired-cohort confirmatory study representing level Ib evidence. PROMIS tested MP-MRI and TRUS-biopsy with respect to an accurate reference test, 5mm sampling of the prostate with template prostate mapping biopsy (TPM-biopsy). In 11 UK centres, men with an elevated PSA up to 15ng/ml with no prior biopsy underwent MP-MRI followed by both TRUS-biopsy and TPM-biopsy. The conduct and reporting of each test was performed blind to the other test results. Clinically significant cancer was defined as Gleason ≥4+3 and/or maximum cancer core length ≥6mm. Results: Between May 2012 and December 2015, 576 men underwent all 3 tests. The reference TPM-biopsy detected clinically significant cance...