title: A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the PROFUS trial.
abstract: BACKGROUND
  Increasing evidence supports the use of magnetic resonance (MR)-targeted prostate biopsy. The optimal method for such biopsy remains undefined, however.
  
  
  OBJECTIVE
  To prospectively compare targeted biopsy outcomes between MR imaging (MRI)-ultrasound fusion and visual targeting.
  
  
  METHODS
  From June 2012 to March 2013, prospective targeted biopsy was performed in 125 consecutive men with suspicious regions identified on prebiopsy 3-T MRI consisting of T2-weighted, diffusion-weighted, and dynamic-contrast enhanced sequences.
  
  
  METHODS
  Two MRI-ultrasound fusion targeted cores per target were performed by one operator using the ei-Nav|Artemis system. Targets were then blinded, and a second operator took two visually targeted cores and a 12-core biopsy.
  
  
  METHODS
  Biopsy information yield was compared between targeting techniques and to 12-core biopsy. Results were analyzed using the McNemar test. Multivariate analysis was performed using binomial logistic regression.
  
  
  CONCLUSIONS
  Among 172 targets, fusion biopsy detected 55 (32.0%) cancers and 35 (20.3%) Gleason sum ≥7 cancers compared with 46 (26.7%) and 26 (15.1%), respectively, using visual targeting (p=0.1374, p=0.0523). Fusion biopsy provided informative nonbenign histology in 77 targets compared with 60 by visual (p=0.0104). Targeted biopsy detected 75.0% of all clinically significant cancers and 86.4% of Gleason sum ≥7 cancers detected on standard biopsy. On multivariate analysis, fusion performed best among smaller targets. The study is limited by lack of comparison with whole-gland specimens and sample size. Furthermore, cancer detection on visual targeting is likely higher than in community settings, where experience with this technique may be limited.
  
  
  CONCLUSIONS
  Fusion biopsy was more often histologically informative than visual targeting but did not increase cancer detection. A trend toward increased detection with fusion biopsy was observed across all study subsets, suggesting a need for a larger study size. Fusion targeting improved accuracy for smaller lesions. Its use may reduce the learning curve necessary for visual targeting and improve community adoption of MR-targeted biopsy.
authors.affiliation: Division of Urologic Oncology, Department of Urology, New York University Langone Medical Center, New York, NY, USA.
authors.forename: James S
authors.initials: JS
authors.lastname: Wysock
authors.affiliation: Department of Radiology, New York University Langone Medical Center, New York, NY, USA.
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Rosenkrantz
authors.affiliation: Division of Urologic Oncology, Department of Urology, New York University Langone Medical Center, New York, NY, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Huang
authors.affiliation: Division of Urologic Oncology, Department of Urology, New York University Langone Medical Center, New York, NY, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Stifelman
authors.affiliation: Division of Urologic Oncology, Department of Urology, New York University Langone Medical Center, New York, NY, USA.
authors.forename: Herbert
authors.initials: H
authors.lastname: Lepor
authors.affiliation: Department of Pathology, New York University Langone Medical Center, New York, NY, USA.
authors.forename: Fang-Ming
authors.initials: FM
authors.lastname: Deng
authors.affiliation: Department of Pathology, New York University Langone Medical Center, New York, NY, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Melamed
authors.affiliation: Division of Urologic Oncology, Department of Urology, New York University Langone Medical Center, New York, NY, USA. Electronic address: samir.taneja@nyumc.org.
authors.forename: Samir S
authors.initials: SS
authors.lastname: Taneja
mesh_terms: D000368:Aged; D005188:False Negative Reactions; D006801:Humans; D007091:Image Processing, Computer-Assisted; D061705:Image-Guided Biopsy / Q000379:methods*; D008279:Magnetic Resonance Imaging; D053783:Magnetic Resonance Imaging, Interventional; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging; D060787:Neoplasm Grading; D011446:Prospective Studies; D011467:Prostate / Q000000981:diagnostic imaging / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology*; D016037:Single-Blind Method; D014463:Ultrasonography
keywords: Magnetic resonance imaging; Prostate biopsy; Prostate cancer; Targeted biopsy