title: NADiA ProsVue prostate-specific antigen slope is an independent prognostic marker for identifying men at reduced risk of clinical recurrence of prostate cancer after radical prostatectomy.
abstract: OBJECTIVE
  To validate the hypothesis that men displaying serum prostate-specific antigen (PSA) slopes ≤ 2.0 pg/mL/mo after prostatectomy, measured using a new immuno-polymerase chain reaction diagnostic test (NADiA ProsVue), have a reduced risk of clinical recurrence as determined by positive biopsy, imaging findings, or death from prostate cancer.
  
  
  METHODS
  From 4 clinical sites, we selected a cohort of 304 men who had been followed up for 17.6 years after prostatectomy for clinical recurrence. We assessed the prognostic value of a PSA slope cutpoint of 2.0 pg/mL/mo against established risk factors to identify men at low risk of clinical recurrence using uni- and multivariate Cox proportional hazards regression and Kaplan-Meier analyses.
  
  
  RESULTS
  The univariate hazard ratio of a PSA slope >2.0 pg/mL/mo was 18.3 (95% confidence interval 10.6-31.8) compared with a slope ≤ 2.0 pg/mL/mo (P <.0001). The median disease-free survival interval was 4.8 years vs >10 years in the 2 groups (P <.0001). The multivariate hazard ratio for PSA slope with the covariates of preprostatectomy PSA, pathologic stage, and Gleason score was 9.8 (95% confidence interval 5.4-17.8), an 89.8% risk reduction for men with PSA slopes ≤ 2.0 pg/mL/mo (P <.0001). The Gleason score (<7 vs ≥ 7) was the only other significant predictor (hazard ratio 5.4, 95% confidence interval 2.1-13.8, P = .0004).
  
  
  CONCLUSIONS
  Clinical recurrence after radical prostatectomy is difficult to predict using established risk factors. We have demonstrated that a NADiA ProsVue PSA slope of ≤ 2.0 pg/mL/mo after prostatectomy is prognostic for a reduced risk of prostate cancer recurrence and adds predictive power to the established risk factors.
authors.affiliation: Division of Urologic Surgery and Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina 27710, USA. judd.moul@duke.edu
authors.forename: Judd W
authors.initials: JW
authors.lastname: Moul
authors.forename: Hans
authors.initials: H
authors.lastname: Lilja
authors.forename: O John
authors.initials: OJ
authors.lastname: Semmes
authors.forename: Raymond S
authors.initials: RS
authors.lastname: Lance
authors.forename: Robert L
authors.initials: RL
authors.lastname: Vessella
authors.forename: Martin
authors.initials: M
authors.lastname: Fleisher
authors.forename: Clarisse
authors.initials: C
authors.lastname: Mazzola
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Sarno
authors.forename: Barbara
authors.initials: B
authors.lastname: Stevens
authors.forename: Robert E
authors.initials: RE
authors.lastname: Klem
authors.forename: Jonathan E
authors.initials: JE
authors.lastname: McDermed
authors.forename: Melissa T
authors.initials: MT
authors.lastname: Triebell
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Adams
mesh_terms: D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011184:Postoperative Period; D011379:Prognosis; D017430:Prostate-Specific Antigen / Q000097:blood*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000473:pathology* / Q000601:surgery; D018570:Risk Assessment
chemical_list: D017430:Prostate-Specific Antigen