TY - JOUR
T1 - 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
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 - Guthrie, David
AU - Chester, John
AU - Cowan, Richard
AU - Jewitt, Michael
AU - Ahmed, H.
AU - Coe, J.
AU - Emberton, M.
AU - Freeman, A.
AU - Kirkham, A.
AU - Scott, R.
AU - Edwards, A.
AU - Smith, J.
AU - Edwards, S.
AU - Day, D.
AU - Ghosh, S.
AU - James, J.
AU - Russell, G.
AU - Sohail, M.
AU - Smart, J.
AU - on behalf of the PROMIS Group
N1 - Funding information: The authors acknowledge funding from the NIHR HTA and Prostate Cancer UK (PG10-17). Prof. Mark Emberton is partially supported by core funding from the NIHR UCH/UCL Biomedical Research Centre. Hashim Ahmed receives funding from the Medical Research Council (UK).
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. For the primary outcome, significant cancer on TPM is defined as Gleason grade >/= 4 + 3 and/or maximum cancer core length of ≥ 6 mm. 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 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. For the primary outcome, significant cancer on TPM is defined as Gleason grade >/= 4 + 3 and/or maximum cancer core length of ≥ 6 mm. 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.
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
VL - 42
SP - 26
EP - 40
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
ER -