title: Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer: Oncologic and Functional Outcomes from the COLD Registry.
abstract: OBJECTIVE
  To evaluate the oncological and functional outcomes of primary cryotherapy in men with clinically localized, high-grade prostate cancer.
  
  
  METHODS
  We included all men with biopsy Gleason score ≥8, localized (cT1-2) disease with a serum prostate-specific antigen (PSA) ≤50 ng/mL from the Cryo On-Line Data (COLD) registry. The primary outcome was biochemical progression free survival (BPFS) as defined by the Phoenix criteria (nadir PSA +2 ng/mL). Secondary outcomes of continence (defined as strictly no leak) and potency (able to have intercourse) were patient reported. Factors influencing BPFS were evaluated individually using Kaplan Meier and in a multivariate model using Cox regression.
  
  
  RESULTS
  Altogether, 300 men were included for analysis. The median follow-up was 18.2 months (mean 28.4) and median BPFS was 69.8 months. Based on Kaplan-Meier analysis, the estimated 2- and 5-year BPFS rate was 77.2% and 59.1%, respectively. Neoadjuvant hormonal therapy was administered to 41% of men and this tended to occur in men with larger prostates, likely as a technical consideration for downsizing before cryosurgery. At multivariate analysis, the presence of Gleason score 9 or 10 (Hazard Ratio [HR] 1.9) and a posttreatment PSA nadir of ≥0.4 ng/mL (HR 5.7) were the only significant variables associated with biochemical progression using Cox regression. Complete continence was noted in 90.5% of men and potency in 17% of men at the 12-month follow-up. The incidence of rectourethral fistulae and urinary retention requiring intervention beyond temporary catheterization was 1.3% and 3.3%, respectively.
  
  
  CONCLUSIONS
  Primary cryotherapy appears to be effective and safe in the community setting for high-grade, clinically localized prostate cancer in the short term.
authors.affiliation: 1 Division of Urology, Duke University , Durham, North Carolina.
authors.forename: Kae Jack
authors.initials: KJ
authors.lastname: Tay
authors.affiliation: 1 Division of Urology, Duke University , Durham, North Carolina.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Polascik
authors.affiliation: 2 Glickman Institute of Urology , Cleveland Clinic, Cleveland, Ohio.|3 Urology Department, Al Kasr Al Aini Hospital, Cairo University , Giza, Egypt .
authors.forename: Ahmed
authors.initials: A
authors.lastname: Elshafei
authors.affiliation: 4 Karmanos Cancer Center, Wayne State University School of Medicine , Detroit, Michigan.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Cher
authors.affiliation: 5 Department of Urology, East Virginia Medical School , Norfolk, Virginia.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Given
authors.affiliation: 6 Florida Hospital, Orlando, Florida.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Mouraviev
authors.affiliation: 7 Department of Urology, Oncology and Pathology, Johns Hopkins School of Medicine , Baltimore, Maryland.
authors.forename: Ashley E
authors.initials: AE
authors.lastname: Ross
authors.affiliation: 2 Glickman Institute of Urology , Cleveland Clinic, Cleveland, Ohio.
authors.forename: J Stephen
authors.initials: JS
authors.lastname: Jones
mesh_terms: D000368:Aged; D001706:Biopsy; D017679:Cryotherapy / Q000379:methods*; D018450:Disease Progression; D018572:Disease-Free Survival; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D060787:Neoplasm Grading; D011183:Postoperative Complications / Q000453:epidemiology; D016016:Proportional Hazards Models; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology / Q000628:therapy*; D012003:Rectal Fistula / Q000453:epidemiology; D012042:Registries; D014522:Urethral Diseases / Q000453:epidemiology; D016055:Urinary Retention / Q000453:epidemiology
chemical_list: D017430:Prostate-Specific Antigen