title: Diagnostic performance and safety of a three-dimensional 14-core systematic biopsy method.
abstract: OBJECTIVE
  To investigate the diagnostic performance and safety of a three-dimensional 14-core biopsy (3D14PBx) method, which is a combination of the transrectal six-core and transperineal eight-core biopsy methods.
  
  
  METHODS
  Between December 2005 and August 2010, 1103 men underwent 3D14PBx at our institutions and were analysed prospectively. Biopsy criteria included a PSA level of 2.5-20 ng/mL or abnormal digital rectal examination (DRE) findings, or both. The primary endpoint of the study was diagnostic performance and the secondary endpoint was safety. We applied recursive partitioning to the entire study cohort to delineate the unique contribution of each sampling site to overall and clinically significant cancer detection.
  
  
  RESULTS
  Prostate cancer was detected in 503 of the 1103 patients (45.6%). Age, family history of prostate cancer, DRE, PSA, percentage of free PSA and prostate volume were associated with the positive biopsy results significantly and independently. Of the 503 cancers detected, 39 (7.8%) were clinically locally advanced (≥cT3a), 348 (69%) had a biopsy Gleason score (GS) of ≥7, and 463 (92%) met the definition of biopsy-based significant cancer. Recursive partitioning analysis showed that each sampling site contributed uniquely to both the overall and the biopsy-based significant cancer detection rate of the 3D14PBx method. The overall cancer-positive rate of each sampling site ranged from 14.5% in the transrectal far lateral base to 22.8% in the transrectal far lateral apex. As of August 2010, 210 patients (42%) had undergone radical prostatectomy, of whom 55 (26%) were found to have pathologically non-organ-confined disease, 174 (83%) had prostatectomy GS ≥7 and 185 (88%) met the definition of prostatectomy-based significant cancer.
  
  
  CONCLUSIONS
  This is the first prospective analysis of the diagnostic performance of an extended biopsy method, which is a simplified version of the somewhat redundant super-extended three-dimensional 26-core biopsy. As expected, each sampling site uniquely contributed not only to overall cancer detection, but also to significant cancer detection. 3D14PBx is a feasible systematic biopsy method in men with PSA <20 ng/mL.
authors.affiliation: Department of Urology, Tokyo Medical and Dental University Graduate School, Tokyo, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Takeshita
authors.forename: Satoru
authors.initials: S
authors.lastname: Kawakami
authors.forename: Noboru
authors.initials: N
authors.lastname: Numao
authors.forename: Mizuaki
authors.initials: M
authors.lastname: Sakura
authors.forename: Manabu
authors.initials: M
authors.lastname: Tatokoro
authors.forename: Shinya
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Toshiki
authors.initials: T
authors.lastname: Kijima
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Komai
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Saito
authors.forename: Fumitaka
authors.initials: F
authors.lastname: Koga
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Fujii
authors.forename: Iwao
authors.initials: I
authors.lastname: Fukui
authors.forename: Kazunori
authors.initials: K
authors.lastname: Kihara
mesh_terms: D000368:Aged; D001706:Biopsy / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D051517:Digital Rectal Examination; D006801:Humans; D008297:Male; D008875:Middle Aged; D010502:Perineum / Q000473:pathology; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology; D011471:Prostatic Neoplasms / Q000473:pathology*; D012007:Rectum / Q000473:pathology
keywords: PSA; detection; extended biopsy; prostate cancer