title: Quantified Clinical Risk Change as an End Point During Prostate Cancer Active Surveillance.
abstract: For men with low-stage prostate cancer (PCa) managed with active surveillance (AS), clinical thresholds for intervention have not been definitively established. We aimed to evaluate whether the magnitude of quantitative risk change may serve as a refined end point. We identified 735 men managed with AS at our institution who received a minimum of two biopsies and who were followed for a median of 52 mo. We described the relative changes in the Cancer of the Prostate Risk Assessment (CAPRA) score from diagnosis to last follow-up and evaluated the proportion of patients experiencing changes in constituent clinical variables. Among patients treated with radical prostatectomy (RP), the association between change in CAPRA score and the occurrence of adverse pathology (pT3a or higher and/or primary Gleason pattern ≥4) was assessed using logistic regression models. Among patients ultimately treated with RP (n=196), unit increases in CAPRA score from diagnosis were associated with the occurrence of adverse pathology (odds ratio: 1.60; 95% confidence interval, 1.25-2.04; p<0.01). On this basis, disease reclassification should be regarded from the vantage of multiple parameters.
  
  
  
  In this study of men with favorable-risk prostate cancer on active surveillance, we evaluated the change in risk status from initial diagnosis to last biopsy using a readily tabulated clinical instrument. Unit change in the Cancer of the Prostate Risk Assessment (CAPRA) score was associated with increasing risk of adverse pathologic findings at delayed prostatectomy. This framework may be useful to stratify men based on the degree of clinical change from baseline over time.
authors.affiliation: Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA. Electronic address: michael.leapman@ucsf.edu.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Leapman
authors.affiliation: Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
authors.forename: Niloufar
authors.initials: N
authors.lastname: Ameli
authors.affiliation: Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA; Epidemiology and Biostatistics, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Cooperberg
authors.affiliation: Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
authors.forename: Carissa
authors.initials: C
authors.lastname: Chu
authors.affiliation: Department of Urology, Cairo University, Egypt.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Hussein
authors.affiliation: Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
authors.forename: Katsuto
authors.initials: K
authors.lastname: Shinohara
authors.affiliation: Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Carroll
mesh_terms: D001706:Biopsy; D000066491:Clinical Decision-Making; D003661:Decision Support Techniques; D023381:Endpoint Determination; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000473:pathology* / Q000628:therapy; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D061665:Time-to-Treatment; D057832:Watchful Waiting
keywords: Active surveillance; CAPRA; End point; Prostate cancer