title: Prospective trial of cryosurgical ablation of the prostate: five-year results.
abstract: OBJECTIVE
  To determine in a prospective pilot study the safety and efficacy of cryosurgical ablation for localized prostate carcinoma.
  
  
  METHODS
  A total of 87 cryosurgical procedures were performed on 76 consecutive patients between December 1994 and February 1998. All patients had histologically proved adenocarcinoma of the prostate, with prostate-specific antigen (PSA) readings of less than 30 ng/mL. Clinical evaluations, PSA determinations, and patient self-reported quality-of-life questionnaires (functional assessment of cancer treatment-prostate; FACT-P) were used to determine biochemical and clinical disease-free status and complications. Patients had a mean follow-up of 50 months (minimum 36).
  
  
  RESULTS
  Follow-up biopsies were performed in 73 patients, and 72 were negative for malignancy after one or more treatments. Ten patients required two treatments and 1 patient required three treatments. The 5-year overall and cancer-specific survival rate was 89% (95% confidence interval, 83% to 97%) and 98.6% (95% confidence interval, 96% to 100%), respectively. The undetectable PSA rate (less than 0.3 ng/mL) for low-risk patients (n = 13) was 60% at 5 years; for moderate-risk patients (n = 23), it was 77%, and for high-risk patients (n = 40), 48%. The corresponding percentage of patients with a PSA level less than 1.0 ng/mL at 5 years was 75%, 89%, and 76%. Sloughing occurred in 3 patients (3.9%), incontinence in 1 (1.3%), and testicular abscess in 1 (1.3%). At 3 years, 18 (47%) of 38 patients capable of unassisted intercourse at the time of cryosurgery had resumed sexual intercourse, 5 spontaneously and 13 with sildenafil or prostaglandin.
  
  
  CONCLUSIONS
  The results of this prospective evaluation show cryosurgery to be both a safe and an effective option in the treatment of localized prostate cancer.
authors.affiliation: Department of Surgery, Tom Baker Cancer Centre and University of Calgary, Calgary, Alberta, Canada.
authors.forename: B J
authors.initials: BJ
authors.lastname: Donnelly
authors.forename: J C
authors.initials: JC
authors.lastname: Saliken
authors.forename: D S
authors.initials: DS
authors.lastname: Ernst
authors.forename: N
authors.initials: N
authors.lastname: Ali-Ridha
authors.forename: P M A
authors.initials: PM
authors.lastname: Brasher
authors.forename: J W
authors.initials: JW
authors.lastname: Robinson
authors.forename: J C
authors.initials: JC
authors.lastname: Rewcastle
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000601:surgery*; D000368:Aged; D003452:Cryosurgery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D017430:Prostate-Specific Antigen