THE EFFICACY AND COMPLICATIONS OF SALVAGE CRYOTHERAPY OF THE PROSTATE

Purpose: A phase I/II study was done to evaluate the efficacy and comp lications of salvage cryotherapy as a treatment for locally recurrent prostate cancer following full dose radiation therapy and/or systemic therapy. The efficacy of single and double freeze-thaw cycles was comp ared using posttreatment prostate specific antigen (PSA) levels and pr ostate biopsies as end points. Materials and Methods: A total of 150 p atients with locally recurrent prostate cancer following radiation, ho rmonal therapy and/or systemic chemotherapy underwent salvage cryother apy using a single (71 men, mean followup 17.3 months) or double (79 m en, mean followup 10.0 months) freeze-thaw cycle. PSA was measured app roximately every 3 months postoperatively and sextant biopsies were re peated 6 months postoperatively. Complications were assessed by retros pective chart review and a mailed quality of life survey. Results: Ove rall, 45 patients (31%) had persistently undetectable PSA. Patients wi th a history of radiation therapy only who underwent a double freeze-t haw cycle had a higher negative biopsy rate (93 versus 71%, p < 0.02) and lower biochemical failure rate (defined as an increase in serum PS A of 0.2 ng./ml. above the nadir value, 44 versus 65%, p < 0.03) than those who underwent a single freeze-thaw cycle. The main complications of salvage cryotherapy were urinary incontinence (73% of the patients ), obstructive symptoms (67%), impotence (72%) and severe perineal pai n (8%). Conclusions: Salvage cryotherapy impacts local tumor control a s evident by the high frequency of negative posttreatment biopsies. A double freeze-thaw cycle appears more effective than a single cycle. L ike salvage prostatectomy, salvage cryotherapy causes significant morb idity.