title: Combination of prostate imaging reporting and data system (PI-RADS) score and prostate-specific antigen (PSA) density predicts biopsy outcome in prostate biopsy naïve patients.
abstract: OBJECTIVE
  To assess the value of the Prostate Imaging Reporting and Data System (PI-RADS) scoring system, for prostate multi-parametric magnetic resonance imaging (mpMRI) to detect prostate cancer, and classical parameters, such as prostate-specific antigen (PSA) level, prostate volume and PSA density, for predicting biopsy outcome in biopsy naïve patients who have suspected prostate cancer.
  
  
  METHODS
  Patients who underwent mpMRI at our hospital, and who had their first prostate biopsy between July 2010 and April 2014, were analysed retrospectively. The prostate biopsies were taken transperineally under transrectal ultrasonography guidance. In all, 14 cores were biopsied as a systematic biopsy in all patients. Two cognitive fusion-targeted biopsy cores were added for each lesion in patients who had suspicious or equivocal lesions on mpMRI. The PI-RADS scoring system version 2.0 (PI-RADS v2) was used to describe the MRI findings. Univariate and multivariate analyses were performed to determine significant predictors of prostate cancer and clinically significant prostate cancer.
  
  
  RESULTS
  In all, 288 patients were analysed. The median patient age, PSA level, prostate volume and PSA density were 69 years, 7.5 ng/mL, 28.7 mL, and 0.26 ng/mL/mL, respectively. The biopsy results were benign, clinically insignificant, and clinically significant prostate cancer in 129 (45%), 18 (6%) and 141 (49%) patients, respectively. The multivariate analysis revealed that PI-RADS v2 score and PSA density were independent predictors for prostate cancer and clinically significant prostate cancer. When PI-RADS v2 score and PSA density were combined, a PI-RADS v2 score of ≥4 and PSA density ≥0.15 ng/mL/mL, or PI-RADS v2 score of 3 and PSA density of ≥0.30 ng/mL/mL, was associated with the highest clinically significant prostate cancer detection rates (76-97%) on the first biopsy. Of the patients in this group with negative biopsy results, 22% were subsequently diagnosed as prostate cancer. In contrast, a PI-RADS v2 score of ≤3 and PSA density of <0.15 ng/mL/mL yielded no clinically significant prostate cancer and no additional detection of prostate cancer on further biopsies.
  
  
  CONCLUSIONS
  A combination of PI-RADS v2 score and PSA density can help in the decision-making process before prostate biopsy and in the follow-up strategy in biopsy naïve patients. Patients with a PI-RADS v2 score of ≤3 and PSA density of <0.15 ng/mL/mL may avoid unnecessary biopsies.
authors.affiliation: Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Washino
authors.affiliation: Department of Radiology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
authors.forename: Tomohisa
authors.initials: T
authors.lastname: Okochi
authors.affiliation: Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
authors.forename: Kimitoshi
authors.initials: K
authors.lastname: Saito
authors.affiliation: Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
authors.forename: Tsuzumi
authors.initials: T
authors.lastname: Konishi
authors.affiliation: Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Hirai
authors.affiliation: Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kobayashi
authors.affiliation: Department of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Miyagawa
mesh_terms: D000368:Aged; D001707:Biopsy, Needle; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D011237:Predictive Value of Tests; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000000981:diagnostic imaging* / Q000473:pathology; D012189:Retrospective Studies
chemical_list: D017430:Prostate-Specific Antigen
keywords: 
  MRI
  ; PI-RADS score; PSA density; prostate biopsy