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 - on behalf of the PROMIS Group
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 - Emberton, Mark
AU - Ahmed, Hashim
AU - Bosaily, Ahmed El Shater
AU - Kirkham, Alex
AU - Freeman, Alex
AU - Jameson, Charles
AU - Hindley, Richard
AU - Parker, Christopher
AU - Cooper, Colin
AU - Oldroyd, Robert
AU - Kaplan, Richard
AU - Brown, Louise
AU - Rhian Gabe, Gabe
AU - Collaco-Moraes, Yolanda
AU - Adusei, Cybil
AU - Ward, Katie
AU - Stewart, Sophie
AU - Mulrenan, Katie Thompson Claire
AU - Gardner, Hannah
AU - Diaz-Montana, Carlos
AU - Coyle, Chris
AU - Sculpher, Mark
AU - Faria, Rita
AU - David Guthrie, Guthrie
AU - Chester, John
AU - Cowan, Richard
AU - Jewitt, Michael
AU - Ahmed, H.
AU - Coe, J.
AU - Emberton, M.
AU - Freeman, A.
AU - Hung, M.
AU - Jameson, C.
AU - Kirkham, A.
AU - Punwani, S.
AU - Scott, R.
AU - Hindley, Richard
AU - Edwards, A.
AU - El-Mahallawi, H.
AU - Peppercorn, D.
AU - Smith, J.
AU - Thrower, A.
N1 - Publisher Copyright:
© 2015 Elsevier Inc.
PY - 2015/5/1
Y1 - 2015/5/1
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 5. mm 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.
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 5. mm 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.
KW - Magnetic resonance imaging
KW - Multi-parametric MRI
KW - Prostate cancer
KW - Template transperineal mapping biopsy
KW - Transrectal ultrasound guided biopsy
KW - Triage diagnostic test
UR - http://www.scopus.com/inward/record.url?scp=84925945782&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2015.02.008
DO - 10.1016/j.cct.2015.02.008
M3 - Article
C2 - 25749312
AN - SCOPUS:84925945782
SN - 1551-7144
VL - 42
SP - 26
EP - 40
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -