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.
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 ≥ 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.
Division of Surgery and Interventional Science, University College London, UK; Department of Urology, UCLH NHS Foundation Trust, UK.
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A
El-Shater Bosaily
Department of Academic Urology, Royal Marsden Hospital, Sutton, UK.
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C
Parker
MRC Clinical Trials Unit at UCL, UK.
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LC
Brown
Department of Health Sciences, University of York, UK.
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R
Gabe
Department of Urology, Hampshire Hospitals NHS Foundation Trust, UK.
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RG
Hindley
MRC Clinical Trials Unit at UCL, UK.
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R
Kaplan
Division of Surgery and Interventional Science, University College London, UK; Department of Urology, UCLH NHS Foundation Trust, UK.
M
M
Emberton
Division of Surgery and Interventional Science, University College London, UK; Department of Urology, UCLH NHS Foundation Trust, UK. Electronic address: hashim.ahmed@ucl.ac.uk.
H U
HU
Ahmed
D003362:Cost-Benefit Analysis; D006801:Humans; D061705:Image-Guided Biopsy; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D060787:Neoplasm Grading; D015588:Observer Variation; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000473:pathology; D012107:Research Design; D012307:Risk Factors
D017430:Prostate-Specific Antigen
Magnetic resonance imaging; Multi-parametric MRI; Prostate cancer; Template transperineal mapping biopsy; Transrectal ultrasound guided biopsy; Triage diagnostic test