Prospective trial of cryosurgical ablation of the prostate: five-year results

• Published in: Urology (Ridgewood, N.J.) Vol. 60; no. 4; pp. 645 - 649
• Main Authors: Donnelly, B.J, Saliken, J.C, Ernst, D.S, Ali-Ridha, N, Brasher, P.M.A, Robinson, J.W, Rewcastle, J.C
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.10.2002; Elsevier Science
• Subjects: Adenocarcinoma - blood; Adenocarcinoma - surgery; Aged; Biological and medical sciences; Cryosurgery; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Pilot Projects; Prospective Studies; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - surgery; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the urinary system; Survival Analysis; Treatment Outcome; Human; Adenocarcinoma; Urinary system disease; Prostate disease; Cryosurgery; Male; Malignant tumor; Survival; Treatment; Surgery; Adult; Prostatectomy; Male genital diseases; Prostate
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/S0090-4295(02)01839-3

To determine in a prospective pilot study the safety and efficacy of cryosurgical ablation for localized prostate carcinoma. 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). 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. The results of this prospective evaluation show cryosurgery to be both a safe and an effective option in the treatment of localized prostate cancer.