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Prospective Outcome Analysis of the Safety and Efficacy of Partial and Complete Cryoablation in Organ-Confined Prostate Cancer.
OBJECTIVES: To determine the rate of complications and change in IPSS and SHIM scores following cryotherapy treatment of low and intermediate risk prostate cancer. Secondary endpoint was change in PSA post-cryotherapy and biopsy-proven recurrence.
METHODS: Enrollment occurred from 2007-2015 to assess long-term complications of cryotherapy. A prostate biopsy was performed at one year or in the event of biochemical failure. Subjects were staged and graded by standard 12-14 core TRUS biopsy. A subset of subjects underwent additional 3DMB if the cancer was suspected to be downgraded. Analyses of functional outcomes were stratified into focal and non-focal treatment.
RESULTS: Study consisted of 393 men with low and intermediate risk prostate cancer, aged 44-89 years. Patient IPSS scores improved significantly in the non-focal treatment strata at all time points, and after 1 year in the focal strata with a median drop at 1 year of 4 points (p<0.001). No significant difference was detected for a change in pre-procedural SHIM score in either treatment strata after two years (p>0.7). 82 patients (20.9%) had a rise in PSA resulting in biochemical failure. 70 patients had detected recurrence for an overall recurrence rate of 20.4% in 343 patients. 109 patients (27.7%) reported urinary retention and urgency post-cryotherapy, with 15.3% requiring catheterization for up to 3 weeks. 37 patients (9.4%) experienced urethral meatal stricture, and 36 patients (9.2%) reported unresolved new-onset ED.
CONCLUSIONS: Complication rates, most significantly erectile dysfunction, are decreased in this study compared those previously reported in the literature for cryotherapy for prostate cancer.
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