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dc.contributor.authorAhmed, HUen_US
dc.contributor.authorEl-Shater Bosaily, Aen_US
dc.contributor.authorBrown, LCen_US
dc.contributor.authorGabe, Ren_US
dc.contributor.authorKaplan, Ren_US
dc.contributor.authorParmar, MKen_US
dc.contributor.authorCollaco-Moraes, Yen_US
dc.contributor.authorWard, Ken_US
dc.contributor.authorHindley, RGen_US
dc.contributor.authorFreeman, Aen_US
dc.contributor.authorKirkham, APen_US
dc.contributor.authorOldroyd, Ren_US
dc.contributor.authorParker, Cen_US
dc.contributor.authorEmberton, Men_US
dc.contributor.authorPROMIS study groupen_US
dc.description.abstractBACKGROUND: Men with high serum prostate specific antigen usually undergo transrectal ultrasound-guided prostate biopsy (TRUS-biopsy). TRUS-biopsy can cause side-effects including bleeding, pain, and infection. Multi-parametric magnetic resonance imaging (MP-MRI) used as a triage test might allow men to avoid unnecessary TRUS-biopsy and improve diagnostic accuracy. METHODS: We did this multicentre, paired-cohort, confirmatory study to test diagnostic accuracy of MP-MRI and TRUS-biopsy against a reference test (template prostate mapping biopsy [TPM-biopsy]). Men with prostate-specific antigen concentrations up to 15 ng/mL, with no previous biopsy, underwent 1·5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. The conduct and reporting of each test was done blind to other test results. Clinically significant cancer was defined as Gleason score ≥4 + 3 or a maximum cancer core length 6 mm or longer. This study is registered on, NCT01292291. FINDINGS: Between May 17, 2012, and November 9, 2015, we enrolled 740 men, 576 of whom underwent 1·5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. On TPM-biopsy, 408 (71%) of 576 men had cancer with 230 (40%) of 576 patients clinically significant. For clinically significant cancer, MP-MRI was more sensitive (93%, 95% CI 88-96%) than TRUS-biopsy (48%, 42-55%; p<0·0001) and less specific (41%, 36-46% for MP-MRI vs 96%, 94-98% for TRUS-biopsy; p<0·0001). 44 (5·9%) of 740 patients reported serious adverse events, including 8 cases of sepsis. INTERPRETATION: Using MP-MRI to triage men might allow 27% of patients avoid a primary biopsy and diagnosis of 5% fewer clinically insignificant cancers. If subsequent TRUS-biopsies were directed by MP-MRI findings, up to 18% more cases of clinically significant cancer might be detected compared with the standard pathway of TRUS-biopsy for all. MP-MRI, used as a triage test before first prostate biopsy, could reduce unnecessary biopsies by a quarter. MP-MRI can also reduce over-diagnosis of clinically insignificant prostate cancer and improve detection of clinically significant cancer. FUNDING: PROMIS is funded by the UK Government Department of Health, National Institute of Health Research-Health Technology Assessment Programme, (Project number 09/22/67). This project is also supported and partly funded by UCLH/UCL Biomedical Research Centre and The Royal Marsden and Institute for Cancer Research Biomedical Research Centre and is coordinated by the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. It is sponsored by University College London (UCL).en_US
dc.format.extent815 - 822en_US
dc.rightsCreative Commons Attribution (CC BY 4.0)
dc.subjectImage-Guided Biopsyen_US
dc.subjectMagnetic Resonance Imagingen_US
dc.subjectNeoplasm Gradingen_US
dc.subjectProspective Studiesen_US
dc.subjectProstate-Specific Antigenen_US
dc.subjectProstatic Neoplasmsen_US
dc.subjectSensitivity and Specificityen_US
dc.subjectUltrasonography, Interventionalen_US
dc.titleDiagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study.en_US
dc.rights.holder© 2017 The Author(s)
pubs.notesNot knownen_US
rioxxterms.funderDefault funderen_US
rioxxterms.identifier.projectDefault projecten_US

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Creative Commons Attribution (CC BY 4.0)
Except where otherwise noted, this item's license is described as Creative Commons Attribution (CC BY 4.0)