MRI-targeted or standard biopsy for prostate-cancer diagnosis

Research output: Contribution to journalArticle

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.)

Details

Authors
  • PRECISION Study Group Collaborators
Organisations
External organisations
  • University College London
  • Helsinki University Central Hospital
  • Sapienza University of Rome
  • Mayo Clinic Minnesota
  • Oulu University Hospital
  • Vita-Salute San Raffaele University
  • University Medical Center Hamburg-Eppendorf
  • Ealing Hospital
  • Great Ormond Street Hospital
  • Erasmus University Medical Center
  • University of Chicago
  • National Health Service Trust, NHS England
  • Lille University Hospital
  • Jewish General Hospital
  • Ghent University Hospital
  • Bern University Hospital
  • University of Bordeaux
  • Radboud University Nijmegen
  • University Hospital Essen
  • University Hospital Heidelberg
  • Centre Hospitalier Lyon Sud
  • New York Presbyterian Hospital/Columbia University Medical Center
  • Lyon Civil Hospital / Hospices Civils de Lyon
  • Sunnybrook Health Sciences Centre
  • NYU Langone
  • National Institutes of Health, United States
  • University of Southern California
  • University of Birmingham
  • Centro de Urología, Buenos Aires
  • Princess Alexandra Hospital NHS Trust
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology
  • Urology and Nephrology
  • Radiology, Nuclear Medicine and Medical Imaging
Original languageEnglish
Pages (from-to)1767-1777
Number of pages11
JournalNew England Journal of Medicine
Volume378
Issue number19
Publication statusPublished - 2018 May 10
Publication categoryResearch
Peer-reviewedYes