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N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.

MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.

Author information

1
From University College London (UCL) and UCL Hospitals NHS Foundation Trust (V.K., C.A., F.G., A.F., S.M., S.P., M.E., C.M.M.), London North West Healthcare NHS Trust (G.H.), Whittington Health NHS Trust (M.G.), Royal Free London NHS Foundation Trust (P.B.S.), and UCL Surgical and Interventional Trials Unit (N.R.W., C.B.-G.), London, Hampshire Hospitals NHS Foundation Trust, Basingstoke (R.G.H.), Princess Alexandra Hospital NHS Trust, Harlow (J.V.), and the Institute of Applied Health Research and the NIHR Birmingham Biomedical Research Centre, University of Birmingham, Birmingham (J.D., Y.T.) - all in the United Kingdom; Helsinki University and Helsinki University Hospital, Helsinki (A.S.R.), and Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.H.V.) - all in Finland; Centro de Urología, Buenos Aires (M.B.); Sapienza University, Rome (V.P.), and IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan (A.B.) - all in Italy; Mayo Clinic, Rochester, MN (L.A.M.); Martini Klinik, Hamburg (L.B.), University Hospital Essen, Essen (B.A.H.), and University Hospital Heidelberg, Heidelberg (B.A.H.) - all in Germany; Erasmus University Medical Center, Rotterdam (M.J.R.), and Radboud University Medical Center, Nijmegen (W.V.) - both in the Netherlands; University of Chicago, Chicago (S.E.); Université de Lille and Centre Hospitalier Universitaire Lille, Lille (A.V.), Université de Bordeaux and Bordeaux Pellegrin University Hospital, Bordeaux (G.R.), and Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud (A.R.), and Hospices Civils de Lyon of the Hôpital Edouard Herriot (S.C.), Lyon - all in France; Jewish General Hospital, Montreal (F.B.), and Sunnybrook Health Sciences Centre, Toronto (L.K.) - both in Canada; Ghent University Hospital, Ghent, Belgium (G.M.V.); University Hospital Bern, Bern, Switzerland (S.B.); Weill Cornell Medicine, New York-Presbyterian Hospital (J.C.H., D.M.), and New York University Langone Medical Center (S.S.T.), New York; National Institutes of Health, Bethesda, MD (P.P.); and the University of Southern California Institute of Urology, Keck School of Medicine, Los Angeles (I.G.).

Abstract

BACKGROUND:

Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited.

METHODS:

In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer.

RESULTS:

A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001).

CONCLUSIONS:

The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).

PMID:
29552975
DOI:
10.1056/NEJMoa1801993
[Indexed for MEDLINE]

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