Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study

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Title: Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study
Author(s): Ahmed, HU
Bosaily, AE-S
Brown, LC
Gabe, R
Kaplan, R
Parmar, MK
Collaco-Moraes, Y
Ward, K
Hindley, RG
Freeman, A
Kirkham, AP
Oldroyd, R
Parker, C
Emberton, M
Item Type: Journal Article
Abstract: Summary Background Men with high serum prostate specifi c antigen usually undergo transrectal ultrasound-guided prostate biopsy (TRUS-biopsy). TRUS-biopsy can cause side-eff ects 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, confi rmatory study to test diagnostic accuracy of MP-MRI and TRUS-biopsy against a reference test (template prostate mapping biopsy [TPM-biopsy]). Men with prostate-specifi c 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 signifi cant cancer was defi ned 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 signifi cant. For clinically signifi cant cancer, MP-MRI was more sensitive (93%, 95% CI 88–96%) than TRUS-biopsy (48%, 42–55%; p<0·0001) and less specifi c (41%, 36–46% for MP-MRI vs 96%, 94–98% for TRUSbiopsy; 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 insignifi cant cancers. If subsequent TRUS-biopsies were directed by MP-MRI findings, up to 18% more cases of clinically signifi cant cancer might be detected compared with the standard pathway of TRUS-biopsy for all. MP-MRI, used as a triage test before fi rst prostate biopsy, could reduce unnecessary biopsies by a quarter. MP-MRI can also reduce over-diagnosis of clinically insignifi cant prostate cancer and improve detection of clinically signifi cant cancer.
Publication Date: 25-Feb-2017
Date of Acceptance: 1-Jan-2017
URI: http://hdl.handle.net/10044/1/53559
DOI: https://dx.doi.org/10.1016/S0140-6736(16)32401-1
ISSN: 0140-6736
Publisher: Elsevier
Start Page: 815
End Page: 822
Journal / Book Title: Lancet
Volume: 389
Issue: 10071
Copyright Statement: © The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license.
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
TUMOR VOLUME
PREDICTIVE VALUES
MAPPING BIOPSIES
TRANSPERINEAL
TESTS
PERFORMANCE
TRIAL
MEN
PROMIS study group
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
TUMOR VOLUME
PREDICTIVE VALUES
MAPPING BIOPSIES
TRANSPERINEAL
TESTS
PERFORMANCE
TRIAL
MEN
11 Medical And Health Sciences
General & Internal Medicine
Publication Status: Published
Appears in Collections:Division of Surgery
Faculty of Medicine



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