title: Are Magnetic Resonance Imaging-Transrectal Ultrasound Guided Targeted Biopsies Noninferior to Transrectal Ultrasound Guided Systematic Biopsies for the Detection of Prostate Cancer?
abstract: OBJECTIVE
  In men with suspicion of prostate cancer the standard of cancer detection is transrectal ultrasound guided 10 to 12-core systematic biopsy. The targeted biopsy only strategy using magnetic resonance imaging-transrectal ultrasound image registration is gaining in popularity. We assessed the noninferiority of targeted vs systematic biopsy.
  
  
  METHODS
  Between June and October 2014 a total of 108 biopsy naïve patients with prostate specific antigen between 4 and 20 ng/ml, normal rectal examination and a single suspicious image on magnetic resonance imaging were included in study at 7 centers. Patients underwent systematic biopsy by a first operator blinded to magnetic resonance imaging, immediately followed by 3 targeted biopsies within the suspicious image by a second operator. The primary end point was the cancer detection rate. The noninferiority margin was set at -5%. The secondary end points were the detection rate of clinically significant prostate cancer (maximum cancer core length 5 mm or greater for Gleason 6 or any Gleason 7 or greater disease) and procedure duration.
  
  
  RESULTS
  Systematic and targeted biopsies detected cancer in 66 (61.1%) and 61 patients (56.5%), respectively. The mean difference was -4.5% with a 95% CI lower bound of -11.8%. A total of 13 patients with protocol violations were excluded from the per protocol analysis, which showed a mean difference of -5.2% with a 95% CI lower bound of -13.1%. Clinically significant prostate cancer was detected in 50 (46.2%) and 52 patients (48.1%) with systematic and targeted biopsies, respectively (p = 0.69). The mean ± SD duration of image fusion plus targeted biopsy was 16.7 ± 7 minutes vs 7.4 ± 3 for systematic biopsy (p <0.001).
  
  
  CONCLUSIONS
  Targeted biopsy seemed to be inferior to systematic biopsy for overall cancer detection. Detection of clinically significant prostate cancer did not differ between targeted and systematic biopsies.
authors.affiliation: Department of Urology, Cochin University Hospital, Paris Descartes University, Paris, France; Inserm Unit U1151, Paris Descartes University, Paris, France. Electronic address: nicolasbdl@hotmail.com.
authors.forename: Nicolas Barry
authors.initials: NB
authors.lastname: Delongchamps
authors.affiliation: Rangueil University Hospital, Toulouse, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Portalez
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Bruguière
authors.affiliation: Hospices Civils de Lyon, Department of Urinary and Vascular Radiology, Edouard Herriot Hospital and University Lyon 1, Lyon, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Rouvière
authors.affiliation: Rangueil University Hospital, Toulouse, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Malavaud
authors.affiliation: Hospices Civils de Lyon, Department of Urinary and Vascular Radiology, Edouard Herriot Hospital and University Lyon 1, Lyon, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Mozer
authors.affiliation: Grenoble University Hospital, Grenoble, France.
authors.forename: Gaelle
authors.initials: G
authors.lastname: Fiard
authors.affiliation: Department of Urology, Cochin University Hospital, Paris Descartes University, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Cornud
mesh_terms: D000328:Adult; D000368:Aged; D019160:Endosonography / Q000379:methods*; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000000981:diagnostic imaging*; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D012007:Rectum; D015203:Reproducibility of Results; D012189:Retrospective Studies
keywords: biopsy; diagnosis; magnetic resonance imaging; prostatic neoplasms; ultrasonography