SALVAGE THERAPY WITH HIGH INTENSITY FOCUSED ULTRASOUND IN LOCAL RADIO RECURRENT PROSTATE CANCER

Introduction & Objectives.- To evaluate the predictive factors for local failure with follow-up- biopsy after whole-gland salvage HIFU in local radio-recurrent PCa pts and to analyses the effects adverse following the therapy in terms of morbidity and quality of life on short-term. Materials and Methods.-From April 2006 to Sept 2010. Fifty-five pts with biopsy-proven localized radio-recurrent PCa and no distant metastasis, were subjected to whole- gland salvage HIFU using Sonablate®500. PSA levels, IPSS, IIEF-5, QoL and Adverse events (CTCAE) questionnaires were assessed at 45, 90, 180 days and 12 months respectivelly. Follow-up biopsy was done systematically at 180 days after treatment. The data was prospectively collected and retrospectively analyzed. Potential predictive factors for local recurrence were explored using forward stepwise conditional regression. For comparison between groups, the Mann-Whitney U test, χ2, and Fisher’s exact test were used where appropriate. Two-sided p values <0.05 were considered statistically significant. Results.-47 pts (85%) had external Beam Radiation, 8(15%) brachytherapy and 17(31%) were underwent to androgen deprivation pre-HIFU treatment. Mean follow-up was 25 (5-56) months. Control biopsies were available in 49(89%) pts. Local relapse was detected in 14 (25%) pts at 180 days. Location of positive biopsy pre-HIFU was an independent predictive factor for local failure (OR:5.81;95%CI 1.65-20.46, p=0.008). The mean post-salvage PSA nadir 0.19(0.02-3.30) ng/ml with a median time of 2.25(1-5-33)months. Erectile dysfunction increased after treatment from 42% to 65% at 1 year (p=0.005). At univariable analysis, prostate volume (p=0.010), IPSS (p=0.002), showed statistical difference at 12 months compared with the basal values. No statistically differences were observed (p=0.064) in the QoL evaluation in pre-HIFU and post therapy at 1 year. Rectourethral fistula occurred in 2(3%) pts, moderate stress urinary incontinence in 2(3%), and urinary retention requiring intervention in 3(5%). 25 pts (45%) presented any AEs post-treatment. In the multivariable analysis clinical stage for T3vsT1 ( OR: 0.09; p=0.017) and Gleason score 6vs7(OR): 4.64; p=0.028) were associated with increased risk of AES. There was no difference in complications between EBRT and BT pts. Conclusions.- Our preliminary results using HIFU showed a low rate of complications with acceptable local cancer control at short- term, being comparable to the reported literature. The lack of long-term follow-up represent the main limitation in the evaluation of feasibility of it minimally invasive treatment. A prospective FDA-sponsored multicenter controlled trial is underway to confirm its utility.