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

El-Shater Bosaily, A., Parker, C., Brown, L. C., Gabe, R., Hindley, R. G., Kaplan, R., Emberton, M., Ahmed, H. U. and , on behalf of the PROMIS Group (2015) 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. Contemporary Clinical Trials, 42. pp. 26-40. ISSN 1551-7144

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Abstract

* 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.

Item Type: Article
Additional Information: 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).
Uncontrolled Keywords: magnetic resonance imaging,multi-parametric mri,prostate cancer,template transperineal mapping biopsy,transrectal ultrasound guided biopsy,triage diagnostic test,pharmacology (medical),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2736
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 18 Jul 2022 16:30
Last Modified: 12 Aug 2022 14:35
URI: https://ueaeprints.uea.ac.uk/id/eprint/86489
DOI: 10.1016/j.cct.2015.02.008

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