Show simple item record

dc.contributor.authorBrown, LC
dc.contributor.authorAhmed, HU
dc.contributor.authorFaria, R
dc.contributor.authorEl-Shater Bosaily, A
dc.contributor.authorGabe, R
dc.contributor.authorKaplan, RS
dc.contributor.authorParmar, M
dc.contributor.authorCollaco-Moraes, Y
dc.contributor.authorWard, K
dc.contributor.authorHindley, RG
dc.contributor.authorFreeman, A
dc.contributor.authorKirkham, A
dc.contributor.authorOldroyd, R
dc.contributor.authorParker, C
dc.contributor.authorBott, S
dc.contributor.authorBurns-Cox, N
dc.contributor.authorDudderidge, T
dc.contributor.authorGhei, M
dc.contributor.authorHenderson, A
dc.contributor.authorPersad, R
dc.contributor.authorRosario, DJ
dc.contributor.authorShergill, I
dc.contributor.authorWinkler, M
dc.contributor.authorSoares, M
dc.contributor.authorSpackman, E
dc.contributor.authorSculpher, M
dc.contributor.authorEmberton, M
dc.date.accessioned2019-06-24T09:15:37Z
dc.date.issued2018-07
dc.identifier.citationHealth technology assessment (Winchester, England), 2018, 22 (39), pp. 1 - 176
dc.identifier.issn1366-5278
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3272
dc.identifier.eissn2046-4924
dc.identifier.doi10.3310/hta22390
dc.description.abstractBackground Men with suspected prostate cancer usually undergo transrectal ultrasound (TRUS)-guided prostate biopsy. TRUS-guided biopsy can cause side effects and has relatively poor diagnostic accuracy. Multiparametric magnetic resonance imaging (mpMRI) used as a triage test might allow men to avoid unnecessary TRUS-guided biopsy and improve diagnostic accuracy.Objectives To (1) assess the ability of mpMRI to identify men who can safely avoid unnecessary biopsy, (2) assess the ability of the mpMRI-based pathway to improve the rate of detection of clinically significant (CS) cancer compared with TRUS-guided biopsy and (3) estimate the cost-effectiveness of a mpMRI-based diagnostic pathway.Design A validating paired-cohort study and an economic evaluation using a decision-analytic model.Setting Eleven NHS hospitals in England.Participants Men at risk of prostate cancer undergoing a first prostate biopsy.Interventions Participants underwent three tests: (1) mpMRI (the index test), (2) TRUS-guided biopsy (the current standard) and (3) template prostate mapping (TPM) biopsy (the reference test).Main outcome measures Diagnostic accuracy of mpMRI, TRUS-guided biopsy and TPM-biopsy measured by sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using primary and secondary definitions of CS cancer. The percentage of negative magnetic resonance imaging (MRI) scans was used to identify men who might be able to avoid biopsy.Results Diagnostic study - a total of 740 men were registered and 576 underwent all three tests. According to TPM-biopsy, the prevalence of any cancer was 71% [95% confidence interval (CI) 67% to 75%]. The prevalence of CS cancer according to the primary definition (a Gleason score of ≥ 4 + 3 and/or cancer core length of ≥ 6 mm) was 40% (95% CI 36% to 44%). For CS cancer, TRUS-guided biopsy showed a sensitivity of 48% (95% CI 42% to 55%), specificity of 96% (95% CI 94% to 98%), PPV of 90% (95% CI 83% to 94%) and NPV of 74% (95% CI 69% to 78%). The sensitivity of mpMRI was 93% (95% CI 88% to 96%), specificity was 41% (95% CI 36% to 46%), PPV was 51% (95% CI 46% to 56%) and NPV was 89% (95% CI 83% to 94%). A negative mpMRI scan was recorded for 158 men (27%). Of these, 17 were found to have CS cancer on TPM-biopsy. Economic evaluation - the most cost-effective strategy involved testing all men with mpMRI, followed by MRI-guided TRUS-guided biopsy in those patients with suspected CS cancer, followed by rebiopsy if CS cancer was not detected. This strategy is cost-effective at the TRUS-guided biopsy definition 2 (any Gleason pattern of ≥ 4 and/or cancer core length of ≥ 4 mm), mpMRI definition 2 (lesion volume of ≥ 0.2 ml and/or Gleason score of ≥ 3 + 4) and cut-off point 2 (likely to be benign) and detects 95% (95% CI 92% to 98%) of CS cancers. The main drivers of cost-effectiveness were the unit costs of tests, the improvement in sensitivity of MRI-guided TRUS-guided biopsy compared with blind TRUS-guided biopsy and the longer-term costs and outcomes of men with cancer.Limitations The PROstate Magnetic resonance Imaging Study (PROMIS) was carried out in a selected group and excluded men with a prostate volume of > 100 ml, who are less likely to have cancer. The limitations in the economic modelling arise from the limited evidence on the long-term outcomes of men with prostate cancer and on the sensitivity of MRI-targeted repeat biopsy.Conclusions Incorporating mpMRI into the diagnostic pathway as an initial test prior to prostate biopsy may (1) reduce the proportion of men having unnecessary biopsies, (2) improve the detection of CS prostate cancer and (3) increase the cost-effectiveness of the prostate cancer diagnostic and therapeutic pathway. The PROMIS data set will be used for future research; this is likely to include modelling prognostic factors for CS cancer, optimising MRI scan sequencing and biomarker or translational research analyses using the blood and urine samples collected. Better-quality evidence on long-term outcomes in prostate cancer under the various management strategies is required to better assess cost-effectiveness. The value-of-information analysis should be developed further to assess new research to commission.Trial registration Current Controlled Trials ISRCTN16082556 and NCT01292291.Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 39. See the NIHR Journals Library website for further project information. This project was also supported and partially funded by the NIHR Biomedical Research Centre at University College London (UCL) Hospitals NHS Foundation Trust and UCL and by The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research Biomedical Research Centre and was co-ordinated by the Medical Research Council's Clinical Trials Unit at UCL (grant code MC_UU_12023/28). It was sponsored by UCL. Funding for the additional collection of blood and urine samples for translational research was provided by Prostate Cancer UK.
dc.formatPrint
dc.format.extent1 - 176
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectProstate
dc.subjectHumans
dc.subjectProstatic Neoplasms
dc.subjectMagnetic Resonance Imaging
dc.subjectSensitivity and Specificity
dc.subjectCohort Studies
dc.subjectQuality-Adjusted Life Years
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectContinental Population Groups
dc.subjectCost-Benefit Analysis
dc.subjectState Medicine
dc.subjectMale
dc.subjectNeoplasm Grading
dc.subjectEndoscopic Ultrasound-Guided Fine Needle Aspiration
dc.subjectUnited Kingdom
dc.titleMultiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study.
dc.typeJournal Article
rioxxterms.versionofrecord10.3310/hta22390
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2018-07
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfHealth technology assessment (Winchester, England)
pubs.issue39
pubs.notesNot known
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.volume22
pubs.embargo.termsNot known
dc.contributor.icrauthorParker, Chrisen


Files in this item

Thumbnail

This item appears in the following collection(s)

Show simple item record

https://creativecommons.org/licenses/by/4.0
Except where otherwise noted, this item's license is described as https://creativecommons.org/licenses/by/4.0