title: Precision Medicine in Active Surveillance for Prostate Cancer: Development of the Canary-Early Detection Research Network Active Surveillance Biopsy Risk Calculator.
abstract: BACKGROUND
  Men on active surveillance (AS) face repeated biopsies. Most biopsy specimens will not show disease progression or change management. Such biopsies do not contribute to patient management and are potentially morbid and costly.
  
  
  OBJECTIVE
  To use a contemporary AS prospective trial to develop a tool to predict AS biopsy outcomes.
  
  
  METHODS
  Biopsy samples (median: 2; range: 2-9 per patient) from 859 men participating in the Canary Prostate Active Surveillance Study and with Gleason 6 prostate cancer (median follow-up: 35.8 mo; range: 3.0-148.7 mo) were analyzed.
  
  
  METHODS
  Logistic regression was used to predict progression, defined as an increase in Gleason score from ≤6 to ≥7 or increase in percentage of cores positive for cancer from <34% to ≥34%. Fivefold internal cross-validation was performed to evaluate the area under the receiver operating characteristic curve (AUC).
  
  
  CONCLUSIONS
  Statistically significant risk factors for progression on biopsy were prostate-specific antigen (odds ratio [OR]: 1.045; 95% confidence interval [CI], 1.028-1.063), percentage of cores positive for cancer on most recent biopsy (OR: 1.401; 95% CI, 1.301-1.508), and history of at least one prior negative biopsy (OR: 0.524; 95% CI, 0.417-0.659). A multivariable predictive model incorporating these factors plus age and number of months since last biopsy achieved an AUC of 72.4%.
  
  
  CONCLUSIONS
  A combination of readily available clinical measures can stratify patients considering AS prostate biopsy. Risk of progression or upgrade can be estimated and incorporated into clinical practice.
  
  
  RESULTS
  The Canary-Early Detection Research Network Active Surveillance Biopsy Risk Calculator, an online tool, can be used to guide patient decision making regarding follow-up prostate biopsy.
authors.affiliation: Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; Life Sciences Mathematics Unit, Technische Universitaet Muenchen, Munich, Germany. Electronic address: ankerst@tum.de.
authors.forename: Donna P
authors.initials: DP
authors.lastname: Ankerst
authors.affiliation: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Jing
authors.initials: J
authors.lastname: Xia
authors.affiliation: Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Thompson
authors.affiliation: Department of Urology, University of Washington, Seattle, WA, USA.
authors.forename: Josef
authors.initials: J
authors.lastname: Hoefler
authors.affiliation: Department of Urology, University of Washington, Seattle, WA, USA.
authors.forename: Lisa F
authors.initials: LF
authors.lastname: Newcomb
authors.affiliation: Department of Urology, Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: James D
authors.initials: JD
authors.lastname: Brooks
authors.affiliation: Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, San Francisco, CA, USA.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Carroll
authors.affiliation: Department of Urology, University of Washington, Seattle, WA, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Ellis
authors.affiliation: Department of Urologic Sciences, The Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Martin E
authors.initials: ME
authors.lastname: Gleave
authors.affiliation: Departments of Microbiology and Molecular Cell Biology and Urology, Eastern Virginia Medical School, Norfolk, VA, USA.
authors.forename: Raymond S
authors.initials: RS
authors.lastname: Lance
authors.affiliation: Division of Human Biology, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Peter S
authors.initials: PS
authors.lastname: Nelson
authors.affiliation: Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Wagner
authors.affiliation: Department of Urology, University of Michigan, Ann Arbor, MI, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Wei
authors.affiliation: Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Etzioni
authors.affiliation: Department of Urology, University of Washington, Seattle, WA, USA.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Lin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research; D001706:Biopsy; D055088:Early Detection of Cancer; D006801:Humans; D008297:Male; D008875:Middle Aged; D057285:Precision Medicine; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology*; D018570:Risk Assessment; D057832:Watchful Waiting
keywords: Active surveillance; Biopsy; Progression; Prostate-specific antigen
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