Presentation Authors: Michael Zachareas*, Beverly, MA, Jim Hu, New York, NY, Juan Martinez-Salamanca, Madrid, Spain, Neal Patel, New York, NY, Estefania Linares, Madrid, Spain, Gloria Egui-Benatouil, Fernando Bianco, Miami Lakes, FL
Introduction: Fusion imaging - MRI/US - of the prostate represents an emerging technology tailored to precision cancer diagnosis and plausible treatment. Here we present our safety profile of our initial MR Fusion Cryoablation technique from 3 centers.
Methods: NCT02381990 (clintrials.gov) is aimed to evaluate treatment outcomes after MR Fusion Target Prostate Cryoablation. Briefly, eligible patients undergo a multi-parametric MRI. MRI treatment planning is outsourced (Focalyx, FL). Perioperative and 30 day safety assessments were obtained from 3 centers: Miami, New York, Boston. Urologists executed the MR Fusion Cryoablation treatment plan that includes with Freeze/thaw (2) cycles. Prospective collection of diagnostic information age, PSA, DRE findings, clinical stage, WHO Modified Gleason scores, co-morbidities, treatment duration, and clavien-dindo systemt 30-day outcomes was performed using Focalyx App (ISO, Android). Patients undergoing focal hemiablation or wholegland treatment were excluded. Only patients with fusion target lesions were eligible.
Results: 83 patients underwent MR Fusion Target Cryoablation for clinically localized prostate cancer. Of these, 35 accrued in Miami, 17 in New York, and 31 in Boston performed under local anesthesia. Procedure execution was consistent across institutions: all performed under 60 minutes. All procedures were completed. mean and median pain scores was 2 (range 0-5). 30-day adverse events were observed in 10 patients, of these: Grade I: 1 referring symptoms consistent with UTI; 2 developed orchitis, 2 perineal hematomas, 3 patients had urinary retention requiring catheters over 7 days but less than 14 days and 1 patients urethral syndrome - frequency and dysuria without retention that lasted 2 weeks. One patient experienced a Grade IIIa adverse event as urinary retention did not improve after 3 weeks and required hospital admission and transurethral resection of the prostate and recovered uneventfully. There were no anesthesia related complications after these procedures. At 3 months PSA levels and average flow rates experienced median delta changes of -3.7 nd/ml (35% decline) and 4.9 cc/s (63% improvement), respectively
Conclusions: This report presents multi-institutional safety data of a novel protocol evaluating men managed with Office based MRI/US fusion target cryoablation. Major adverse events occurred in one patient. The absence of regional or general anesthesia added to the safety profile