title: Visually directed vs. software-based targeted biopsy compared to transperineal template mapping biopsy in the detection of clinically significant prostate cancer.
abstract: OBJECTIVE
  Targeted biopsy based on cognitive or software magnetic resonance imaging (MRI) to transrectal ultrasound registration seems to increase the detection rate of clinically significant prostate cancer as compared with standard biopsy. However, these strategies have not been directly compared against an accurate test yet. The aim of this study was to obtain pilot data on the diagnostic ability of visually directed targeted biopsy vs. software-based targeted biopsy, considering transperineal template mapping (TPM) biopsy as the reference test.
  
  
  METHODS
  Prospective paired cohort study included 50 consecutive men undergoing TPM with one or more visible targets detected on preoperative multiparametric MRI. Targets were contoured on the Biojet software. Patients initially underwent software-based targeted biopsies, then visually directed targeted biopsies, and finally systematic TPM. The detection rate of clinically significant disease (Gleason score ≥3+4 and/or maximum cancer core length ≥4mm) of one strategy against another was compared by 3×3 contingency tables. Secondary analyses were performed using a less stringent threshold of significance (Gleason score ≥4+3 and/or maximum cancer core length ≥6mm).
  
  
  RESULTS
  Median age was 68 (interquartile range: 63-73); median prostate-specific antigen level was 7.9ng/mL (6.4-10.2). A total of 79 targets were detected with a mean of 1.6 targets per patient. Of these, 27 (34%), 28 (35%), and 24 (31%) were scored 3, 4, and 5, respectively. At a patient level, the detection rate was 32 (64%), 34 (68%), and 38 (76%) for visually directed targeted, software-based biopsy, and TPM, respectively. Combining the 2 targeted strategies would have led to detection rate of 39 (78%). At a patient level and at a target level, software-based targeted biopsy found more clinically significant diseases than did visually directed targeted biopsy, although this was not statistically significant (22% vs. 14%, P = 0.48; 51.9% vs. 44.3%, P = 0.24). Secondary analysis showed similar results. Based on these findings, a paired cohort study enrolling at least 257 men would verify whether this difference is statistically significant.
  
  
  CONCLUSIONS
  The diagnostic ability of software-based targeted biopsy and visually directed targeted biopsy seems almost comparable, although utility and efficiency both seem to be slightly in favor of the software-based strategy. Ongoing trials are sufficiently powered to prove or disprove these findings.
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals NHS Foundation Trust, London, United Kingdom; Department of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Electronic address: massimo.valerio.12@ucl.ac.uk.
authors.forename: Massimo
authors.initials: M
authors.lastname: Valerio
authors.affiliation: Department of Urology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Neil
authors.initials: N
authors.lastname: McCartan
authors.affiliation: Department of Pathology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Alex
authors.initials: A
authors.lastname: Freeman
authors.affiliation: Department of Radiology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Shonit
authors.initials: S
authors.lastname: Punwani
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Mark
authors.initials: M
authors.lastname: Emberton
authors.affiliation: Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospitals NHS Foundation Trust, London, United Kingdom.
authors.forename: Hashim U
authors.initials: HU
authors.lastname: Ahmed
mesh_terms: D000368:Aged; D015331:Cohort Studies; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods*; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D012984:Software; D025321:Surgery, Computer-Assisted / Q000379:methods*; D013520:Urologic Surgical Procedures / Q000379:methods*
keywords: Computer assisted; Image processing; Image-guided biopsy; Magnetic resonance imaging; Prostate neoplasms; Software; Targeted biopsy