title: Medium-term outcomes of active surveillance for localised prostate cancer.
abstract: BACKGROUND
  Active surveillance (AS) aims to allow men with favourable-risk, localised prostate cancer to avoid unnecessary treatment.
  
  
  OBJECTIVE
  To describe the clinical outcomes of a prospective study of AS.
  
  
  METHODS
  A single-centre, prospective cohort study. Eligibility criteria included histologically proven prostate adenocarcinoma, age 50-80 yr, stage T1/T2, prostate-specific antigen level (PSA) <15 ng/ml, Gleason score (GS) ≤ 3+3 (GS ≤ 3+4 if aged >65 yr), and percent positive biopsy cores (PPC) ≤ 50%.
  
  
  METHODS
  Patients were assessed by serum PSA level, and digital rectal examination at 3-mo intervals in year 1, 4-mo intervals in year 2, and at 6-mo intervals thereafter. Transrectal ultrasound-guided prostate biopsy was performed after 18-24 mo and every 2 yr thereafter. Treatment was recommended for PSA velocity (PSAV) >1 ng/ml per year or adverse histology, defined as GS ≥ 4+3 or PPC >50%.
  
  
  METHODS
  Outcomes described, using Kaplan-Meier methods, were rate of adverse histology on repeat biopsy, freedom from treatment, biochemical control after deferred treatment, and overall survival. Analyses using Cox regression were performed to determine predictors of deferred treatment and adverse histology.
  
  
  CONCLUSIONS
  The study enrolled 471 eligible patients from 2002 to 2011. Median age was 66 yr and median initial PSA value was 6.4 ng/ml. Eighty-eight percent of patients had T1 disease and 93% had GS ≤ 3+3. At median follow-up of 5.7 yr, the 5-yr rate of adverse histology and treatment-free probability was 22% (95% confidence interval [CI], 16-29%) and 70% (95% CI, 65-75%), respectively. There were two deaths from prostate cancer. Predictors of time to adverse histology were GS 7, PSAV >1 ng/ml per year, low ratio of free PSA to total PSA, and PPC >25%. Longer follow-up is needed to confirm the safety of this strategy.
  
  
  CONCLUSIONS
  This study demonstrates satisfactory medium-term outcomes for AS in selected men with localised prostate cancer.
authors.affiliation: The Royal Marsden Hospital, Sutton, Surrey, UK; The Institute of Cancer Research, Sutton, Surrey, UK.
authors.forename: Elizabeth D
authors.initials: ED
authors.lastname: Selvadurai
authors.forename: Mausam
authors.initials: M
authors.lastname: Singhera
authors.forename: Karen
authors.initials: K
authors.lastname: Thomas
authors.forename: Kabir
authors.initials: K
authors.lastname: Mohammed
authors.forename: Ruth
authors.initials: R
authors.lastname: Woode-Amissah
authors.forename: Alan
authors.initials: A
authors.lastname: Horwich
authors.forename: Robert A
authors.initials: RA
authors.lastname: Huddart
authors.forename: David P
authors.initials: DP
authors.lastname: Dearnaley
authors.forename: Chris C
authors.initials: CC
authors.lastname: Parker
mesh_terms: D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D057832:Watchful Waiting
keywords: Active surveillance; Outcomes; Prostate cancer