title: Should inclusion criteria for active surveillance for low-risk prostate cancer be more stringent? From an interim analysis of PRIAS-JAPAN.
abstract: OBJECTIVE
  To define clinical and pathological factors predicting reclassification at the time of 1-year repeat biopsy (re-Bx) based on a Japanese cohort forming part of the Prostate Research International: Active Surveillance (PRIAS) study.
  
  
  METHODS
  The inclusion criteria for the PRIAS study are as follows: clinical stage T1c/T2, PSA ≤ 10 ng/ml, PSA density (PSAD) < 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) ≤ 6 at initial diagnostic biopsy. Baseline clinical characteristics and prostate-specific antigen doubling time (PSADT) at the time of re-Bx were analyzed via multivariate logistic regression with respect to reclassification and 'no cancer' status on the 1-year re-Bx.
  
  
  RESULTS
  A total of 386 patients were enrolled in PRIAS-JAPAN by the end of 2013. Of these, 216 underwent re-Bx at 1 year. A total of 73 patients (33.8 %) were reclassified, whereas 74 (34.3 %) had no cancer. Older age, a higher PSAD, a higher positive core rate, and a shorter PSADT were significant predictors of reclassification. The positive core rate was the predictor common to reclassification, no cancer, and high GS, upon re-Bx.
  
  
  CONCLUSIONS
  An interim analysis of a Japanese AS cohort participating in PRIAS revealed that the positive core rate was strongly associated with reclassification at the 1-year re-Bx. However, although amendment of the PRIAS inclusion criteria to incorporate a positive core might reduce any concern about underestimation, this would also reduce the number of patients undergoing AS.
authors.affiliation: Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan, micsugi@med.kagawa-u.ac.jp.
authors.forename: Mikio
authors.initials: M
authors.lastname: Sugimoto
authors.forename: Hiromi
authors.initials: H
authors.lastname: Hirama
authors.forename: Akito
authors.initials: A
authors.lastname: Yamaguchi
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Koga
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Hashine
authors.forename: Iku
authors.initials: I
authors.lastname: Ninomiya
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shinohara
authors.forename: Satoru
authors.initials: S
authors.lastname: Maruyama
authors.forename: Shin
authors.initials: S
authors.lastname: Egawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sasaki
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Kakehi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D062005:Biopsy, Large-Core Needle; D015331:Cohort Studies; D006801:Humans; D007564:Japan; D007610:Kallikreins / Q000097:blood; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D018579:Patient Selection; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000473:pathology*; D018570:Risk Assessment; D057832:Watchful Waiting
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen