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dc.contributor.authorAhmed, HU
dc.contributor.authorEl-Shater Bosaily, A
dc.contributor.authorBrown, LC
dc.contributor.authorGabe, R
dc.contributor.authorKaplan, R
dc.contributor.authorParmar, MK
dc.contributor.authorCollaco-Moraes, Y
dc.contributor.authorWard, K
dc.contributor.authorHindley, RG
dc.contributor.authorFreeman, A
dc.contributor.authorKirkham, AP
dc.contributor.authorOldroyd, R
dc.contributor.authorParker, C
dc.contributor.authorEmberton, M
dc.contributor.authorPROMIS study group
dc.date.accessioned2017-03-01T12:08:16Z
dc.date.issued2017-02
dc.identifier.citationLancet (London, England), 2017, 389 (10071), pp. 815 - 822
dc.identifier.issn0140-6736
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/434
dc.identifier.eissn1474-547X
dc.identifier.doi10.1016/s0140-6736(16)32401-1
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 ClinicalTrials.gov, 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).
dc.formatPrint-Electronic
dc.format.extent815 - 822
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectPROMIS study group
dc.subjectHumans
dc.subjectProstatic Neoplasms
dc.subjectProstate-Specific Antigen
dc.subjectMagnetic Resonance Imaging
dc.subjectUltrasonography, Interventional
dc.subjectSensitivity and Specificity
dc.subjectProspective Studies
dc.subjectMale
dc.subjectNeoplasm Grading
dc.subjectImage-Guided Biopsy
dc.titleDiagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study.
dc.typeJournal Article
dcterms.dateAccepted2016-09-27
rioxxterms.versionofrecord10.1016/s0140-6736(16)32401-1
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2017-02
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfLancet (London, England)
pubs.issue10071
pubs.notesNo embargo
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume389
pubs.embargo.termsNo embargo
dc.contributor.icrauthorParker, Chrisen
dc.contributor.icrauthorMarsden,en


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