Five-Year Results Published for SonaCare's Sonablate HIFU System to Treat Prostate Cancer
July 11, 2018—SonaCare Medical, a developer of high-intensity–focused ultrasound (HIFU) technologies, announced 5-year outcomes from a multicenter study of focal therapy treatment with the company's Sonablate technology of 625 medium- to high-risk patients with clinically significant nonmetastatic prostate cancer. The findings were published by Stephanie Guillaumier, MD, et al online ahead of print in European Urology.
SonaCare reported that with a median 5-year follow-up, failure-free survival at 1, 3, and 5 years was 99%, 92%, and 88%, respectively—equivalent to that achieved with surgery. Metastasis-free, cancer-specific, and overall survival at 5 years was 98%, 100%, and 99%, respectively. Additionally, the study found that 98% of patients maintained pad-free urinary continence after their procedure and 85% maintained erectile function, both material improvements over that seen with surgery and radiation therapy.
The study concluded that failure-free survival with HIFU can be equivalent to that of surgery but with a side effect profile that is far more beneficial to the patient's quality of life postprocedure.
The company noted that a recent report from the United Kingdom on 1,000 patients who underwent a radical prostatectomy found maintenance of pad-free continence at only 65%, which suggests that focal HIFU therapy can result in a 97% reduction in the number of patients who require pads postprocedure when compared to surgery. Ancillary data suggest a similar magnitude reduction in erectile dysfunction with focal HIFU compared to surgery.
The Sonablate system received FDA 510(k) clearance in October 2015. It is indicated for the transrectal HIFU ablation of prostatic tissue.
Study investigator, Professor Hashim Ahmed, MD, commented in SonaCare's announcement, "Focal HIFU is a major shift in treating men with early prostate cancer. Our study shows that cancer control in the medium-term is very good and importantly, men can expect a low-risk of side effects such as incontinence and erection problems. All men who are suitable for focal HIFU should be told about this treatment option so they might consider it as an alternative to radical prostatectomy or radiotherapy." Prof. Ahmed is Chair of Urology at Imperial College London in London, United Kingdom.