PROMIS - Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer

TY - JOUR

T1 - PROMIS - Prostate MR imaging study

T2 - A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer

AU - El-Shater Bosaily, A

AU - Parker, C

AU - Brown, L C

AU - Gabe, R

AU - Hindley, R G

AU - Kaplan, R

AU - Emberton, M

AU - Ahmed, H U

AU - PROMIS Group

N1 - Copyright © 2015 Elsevier Inc. All rights reserved.

PY - 2015/5

Y1 - 2015/5

N2 - BACKGROUND: Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multi-parametric MRI (MP-MRI) may improve the diagnostic pathway.METHODS: PROMIS is a prospective validating paired-cohort study that meets criteria for level 1 evidence in diagnostic test evaluation. PROMIS will investigate whether multi-parametric (MP)-MRI can discriminate between men with and without clinically-significant prostate cancer who are at risk prior to first biopsy. Up to 714 men will have MP-MRI (index), 10-12 core TRUS-biopsy (standard) and 5mm transperineal template mapping (TPM) biopsies (reference). The conduct and reporting of each test will be blinded to the others.RESULTS: PROMIS will measure and compare sensitivity, specificity, and positive and negative predictive values of both MP-MRI and TRUS-biopsy against TPM biopsies. The MP-MRI results will be used to determine the proportion of men who could safely avoid biopsy without compromising detection of clinically-significant cancers. For the primary outcome, significant cancer on TPM is defined as Gleason grade>/=4+3 and/or maximum cancer core length of ≥6mm. PROMIS will also assess inter-observer variability among radiologists among other secondary outcomes. Cost-effectiveness of MP-MRI prior to biopsy will also be evaluated.CONCLUSIONS: PROMIS will determine whether MP-MRI of the prostate prior to first biopsy improves the detection accuracy of clinically-significant cancer.

AB - BACKGROUND: Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multi-parametric MRI (MP-MRI) may improve the diagnostic pathway.METHODS: PROMIS is a prospective validating paired-cohort study that meets criteria for level 1 evidence in diagnostic test evaluation. PROMIS will investigate whether multi-parametric (MP)-MRI can discriminate between men with and without clinically-significant prostate cancer who are at risk prior to first biopsy. Up to 714 men will have MP-MRI (index), 10-12 core TRUS-biopsy (standard) and 5mm transperineal template mapping (TPM) biopsies (reference). The conduct and reporting of each test will be blinded to the others.RESULTS: PROMIS will measure and compare sensitivity, specificity, and positive and negative predictive values of both MP-MRI and TRUS-biopsy against TPM biopsies. The MP-MRI results will be used to determine the proportion of men who could safely avoid biopsy without compromising detection of clinically-significant cancers. For the primary outcome, significant cancer on TPM is defined as Gleason grade>/=4+3 and/or maximum cancer core length of ≥6mm. PROMIS will also assess inter-observer variability among radiologists among other secondary outcomes. Cost-effectiveness of MP-MRI prior to biopsy will also be evaluated.CONCLUSIONS: PROMIS will determine whether MP-MRI of the prostate prior to first biopsy improves the detection accuracy of clinically-significant cancer.

U2 - 10.1016/j.cct.2015.02.008

DO - 10.1016/j.cct.2015.02.008

M3 - Article

C2 - 25749312

SN - 1551-7144

VL - 42

SP - 26

EP - 40

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

ER -