title: Predictors of biochemical failure in patients undergoing prostate whole-gland salvage cryotherapy: a novel risk stratification model.
abstract: What's known on the subject? and what does the study add?: Previous studies have identified the most important prognostic factors of the likely outcomes of salvage prostate whole-gland ablation, including initial clinical stage, biopsy Gleason score, and PSA (total and doubling time). There is potential for further optimization of candidate selection for salvage cryoablation with curative intent and nadir PSA achieved after whole-gland cryotherapy may provide additional prognostic value. The study shows that the most important prognostic factors of biochemical progression-free survival for patients who have undergone whole-gland salvage prostate cryotherapy are nadir PSA achieved after therapy and pre-therapy biopsy Gleason score. Based on these two prognostic variables, we have identified risk stratification groups (low, intermediate and high) which help predict the expected outcomes of salvage whole-gland prostate cryotherapy in a given patient. This risk stratification constitutes a useful clinical tool in defining which patients maybe best suited for this local salvage treatment method.
  
  
  OBJECTIVE
  To assess the prognostic variables predicting the risk of biochemical progression-free survival (bPFS) after salvage prostate whole-gland cryotherapy using the Phoenix definition of bPFS.
  
  
  METHODS
  A total of 132 patients underwent prostate whole-gland salvage cryotherapy with curative intent. No patient underwent neoadjuvant/adjuvant hormonal ablative therapy, and all had extended post-salvage prostate-specific antigen (PSA) follow-up data. Cox univariate and multivariate logistic regression analyses of potential predictors of bPFS were conducted. Kaplan-Meier analyses of bPFS was also performed.
  
  
  RESULTS
  At a mean (range) follow-up of 4.3 (0.9-12.7) years, the median (range) post-cryotherapy nadir PSA achieved was 0.17 (0-33.9) ng/mL. On multivariate analysis, predictors of bPFS were nadir PSA post-cryotherapy and pre-salvage biopsy Gleason score (P < 0.001 and 0.009, respectively). Risk stratification groups (low, intermediate and high) were developed based on the presence of zero, one or two adverse risk factors, the risk factors being either a nadir PSA >2.5 ng/mL or biopsy Gleason score ≥ 7, with the Kaplan-Meier bPFS curves of these risk groups being significantly different (P = 0.02 and <0.001, respectively).
  
  
  CONCLUSIONS
  Post-salvage nadir PSA and pre-salvage biopsy Gleason score are important predictors of outcome in this patient cohort. Low-, intermediate- and high-risk groups can be determined based on these variables and can define patients best suited for prostate cryotherapy.
authors.affiliation: Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL 33612, USA. philippe.spiess@moffitt.org
authors.forename: Philippe E
authors.initials: PE
authors.lastname: Spiess
authors.forename: David A
authors.initials: DA
authors.lastname: Levy
authors.forename: Vladimir
authors.initials: V
authors.lastname: Mouraviev
authors.forename: Louis L
authors.initials: LL
authors.lastname: Pisters
authors.forename: J Stephen
authors.initials: JS
authors.lastname: Jones
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017679:Cryotherapy; D018572:Disease-Free Survival; D006801:Humans; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000453:epidemiology*; D011379:Prognosis; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000628:therapy*; D018570:Risk Assessment; D016879:Salvage Therapy / Q000379:methods*; D017211:Treatment Failure
chemical_list: D017430:Prostate-Specific Antigen
keywords: biochemical failure; nadir PSA; prostate cancer; risk groups; salvage cryotherapy