title: Disease reclassification risk with stringent criteria and frequent monitoring in men with favourable-risk prostate cancer undergoing active surveillance.
abstract: To determine the frequency of disease reclassification and to identify clinicopathological variables associated with it in patients with favourable-risk prostate cancer undergoing active surveillance (AS).
  
  
  
  We assessed 191 men, selected by what may be the most stringent criteria used in AS studies yet conducted, who were enrolled in a prospective cohort AS trial. Clinicopathological characteristics were analysed in a multivariate Cox proportional hazards regression model. Key features were an extended biopsy with a single core positive for Gleason score (GS) 3 + 3 (<3 mm) or 3 + 4 (<2 mm) and a prostate-specific antigen (PSA) level <4 ng/mL (adjusted for prostate volume). Biopsies were repeated every 1-2 years and clinical evaluations every 6 months. Disease was reclassified when PSA level increased by 30% from baseline, or when biopsy tumour length increased beyond the enrolment criteria, more than one positive core was detected or any grade increased to a dominant 4 pattern or any 5 pattern.
  
  
  
  Disease was reclassified in 32 patients (16.8%) including upgrading to GS 4 + 3 in five patients (2.6%). The median (interquartile range) follow-up time among survivors was 3 (1.9-4.6) years. Overall, 13 of the 32 (40.6%) had incremental increases in GS. Tumour length (hazard ratio 2.95, 95% confidence interval [CI] 1.34-6.46; P = 0.007) and older age (hazard ratio 1.05, 95% CI 1.00-1.09; P = 0.05) were identified as significant and marginally significant predictors of disease reclassification, respectively. Disease remained stable in 83.2% of patients.
  
  
  
  The need persists for improvements in risk stratification and predictive indicators of cancer progression.
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: John W
authors.initials: JW
authors.lastname: Davis
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: John F
authors.initials: JF
authors.lastname: Ward
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Curtis A
authors.initials: CA
authors.lastname: Pettaway
authors.affiliation: Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Xuemei
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Kuban
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Frank
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Andrew K
authors.initials: AK
authors.lastname: Lee
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Louis L
authors.initials: LL
authors.lastname: Pisters
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Surena F
authors.initials: SF
authors.lastname: Matin
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Jay B
authors.initials: JB
authors.lastname: Shah
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Jose A
authors.initials: JA
authors.lastname: Karam
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Brian F
authors.initials: BF
authors.lastname: Chapin
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: John N
authors.initials: JN
authors.lastname: Papadopoulos
authors.affiliation: Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Achim
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Karen E
authors.initials: KE
authors.lastname: Hoffman
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Pugh
authors.affiliation: Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Seungtaek
authors.initials: S
authors.lastname: Choi
authors.affiliation: Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Patricia
authors.initials: P
authors.lastname: Troncoso
authors.affiliation: Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Logothetis
authors.affiliation: Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Jeri
authors.initials: J
authors.lastname: Kim
mesh_terms: D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000145:classification* / Q000175:diagnosis / Q000628:therapy*; D018570:Risk Assessment; D057832:Watchful Waiting
keywords: active surveillance; biopsy; prostate; prostate cancer; tumour; watchful waiting