title: The Epstein criteria predict for organ-confined but not insignificant disease and a high likelihood of cure at radical prostatectomy.
abstract: BACKGROUND
  Few reports attempt to validate the role of Epstein criteria in selecting patients for an active surveillance protocol.
  
  
  OBJECTIVE
  To determine the performance of the Epstein biopsy criteria for predicting pathologic end points and biochemical relapse-free survival (bRFS) in men with early stage prostate cancer (PCa) treated by radical prostatectomy (RP).
  
  
  METHODS
  Between October 1999 and January 2007, 746 consecutive patients were biopsied, and then underwent RP at our tertiary care institution. Two hundred sixty-eight patients met the entry criteria of Gleason 6 disease only on initial biopsy with complete pathologic information.
  
  
  METHODS
  Primary end point was insignificant disease. Insignificant disease was defined using a classical (organ-confined, Gleason score <6, and tumor volume <0.5 cm(3)) and more liberal (organ-confined, Gleason <6 tumor of any volume) formulation. Secondary end points included organ-confined disease and bRFS.
  
  
  CONCLUSIONS
  One hundred thirty-six men (51%) met the Epstein biopsy criteria, and 167 (62%) had organ-confined cancer. Insignificant disease by the classical and liberal definitions was present in 68 (25%) and 92 (34%) patients, respectively. Cases meeting Epstein biopsy criteria were more likely to have insignificant disease by either definition (p<0.001) and more likely to have organ-confined tumors (p<0.001). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) varied widely among the end points, with sensitivity (74%) and NPV (86%) best for the classical definition of insignificant disease and specificity (74%) and PPV (92%) best for organ-confined disease. The estimated 5-yr bRFS was 100% for those meeting Epstein biopsy criteria compared to 83% for those not meeting these criteria.
  
  
  CONCLUSIONS
  The Epstein biopsy criteria predict for a high likelihood of organ-confined disease and the absence of biochemical failure up to 5 yr after RP. These criteria are insufficiently robust to predict the presence of biologically insignificant disease.
authors.affiliation: Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA. leem2@ccf.org
authors.forename: Michael C
authors.initials: MC
authors.lastname: Lee
authors.forename: Fei
authors.initials: F
authors.lastname: Dong
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Stephenson
authors.forename: J Stephen
authors.initials: JS
authors.lastname: Jones
authors.forename: Cristina
authors.initials: C
authors.lastname: Magi-Galluzzi
authors.forename: Eric A
authors.initials: EA
authors.lastname: Klein
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D018572:Disease-Free Survival; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology*; D009367:Neoplasm Staging; D018579:Patient Selection; D011379:Prognosis; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000401:mortality / Q000473:pathology* / Q000601:surgery*; D047368:Tumor Burden
chemical_list: D017430:Prostate-Specific Antigen