title: Role of prostate specific antigen and immediate confirmatory biopsy in predicting progression during active surveillance for low risk prostate cancer.
abstract: OBJECTIVE
  We evaluated predictors of progression after starting active surveillance, especially the role of prostate specific antigen and immediate confirmatory prostate biopsy.
  
  
  METHODS
  A total of 238 men with prostate cancer met active surveillance eligibility criteria and were analyzed for progression with time. Cox proportional hazards regression was used to evaluate predictors of progression. Progression was evaluated using 2 definitions, including no longer meeting 1) full and 2) modified criteria, excluding prostate specific antigen greater than 10 ng/ml as a criterion.
  
  
  RESULTS
  Using full criteria 61 patients progressed during followup. The 2 and 5-year progression-free probability was 80% and 60%, respectively. With prostate specific antigen included in progression criteria prostate specific antigen at confirmatory biopsy (HR 1.29, 95% CI 1.14-1.46, p <0.0005) and positive confirmatory biopsy (HR 1.75, 95% CI 1.01-3.04, p = 0.047) were independent predictors of progression. Of the 61 cases 34 failed due to increased prostate specific antigen, including only 5 with subsequent progression by biopsy criteria. When prostate specific antigen was excluded from progression criteria, only 32 cases progressed, and 2 and 5-year progression-free probability was 91% and 76%, respectively. Using modified criteria as an end point positive confirmatory biopsy was the only independent predictor of progression (HR 3.16, 95% CI 1.41-7.09, p = 0.005).
  
  
  CONCLUSIONS
  Active surveillance is feasible in patients with low risk prostate cancer and most patients show little evidence of progression within 5 years. There is no clear justification for treating patients in whom prostate specific antigen increases above 10 ng/ml in the absence of other indications of tumor progression. Patients considering active surveillance should undergo confirmatory biopsy to better assess the risk of progression.
authors.affiliation: Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA. ariadamy@gmail.com
authors.forename: Ari
authors.initials: A
authors.lastname: Adamy
authors.forename: David S
authors.initials: DS
authors.lastname: Yee
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Matsushita
authors.forename: Alexandra
authors.initials: A
authors.lastname: Maschino
authors.forename: Angel
authors.initials: A
authors.lastname: Cronin
authors.forename: Andrew
authors.initials: A
authors.lastname: Vickers
authors.forename: Bertrand
authors.initials: B
authors.lastname: Guillonneau
authors.forename: Peter T
authors.initials: PT
authors.lastname: Scardino
authors.forename: James A
authors.initials: JA
authors.lastname: Eastham
mesh_terms: D000328:Adult; D000368:Aged; D014408:Biomarkers, Tumor / Q000097:blood*; D001707:Biopsy, Needle; D015331:Cohort Studies; D016001:Confidence Intervals; D018450:Disease Progression; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000401:mortality / Q000473:pathology*; D012189:Retrospective Studies; D018570:Risk Assessment; D013997:Time Factors; D057832:Watchful Waiting / Q000379:methods*
chemical_list: D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen