The FDA has announced clearance for a minimally invasive high-intensity focused ultrasound (HIFU) prostate tissue ablation device called Sonablate 450, making HIFU available in the United States for the first time.
The FDA has announced ade novoclearance for a minimally invasive high-intensity focused ultrasound (HIFU) prostate tissue ablation device called Sonablate 450. This clearance marks the first time HIFU technology will be used in the United States.
“It is anticipated that ablative urological surgeons in the US will quickly master and adapt this technology for their patients,” said Herbert Lepor, MD, professor and Martin Spatz Chairman, Department of Urology, New York University School of Medicine, in a statement. “HIFU offers the opportunity for the precise delivery of ablative energy to the prostate. Thus, it can be adapted to whole gland or focal gland ablation.”
Sonablate 450 is used on patients with low-to-high-risk prostate cancer with a PSA lower than 10 ng/mL who have progressed on external beam radiation therapy. The device utilizes a fully integrated probe with dual ablation transducer and focuses ultrasound energy at a targeted location in the prostate gland called the focal point, which is heated to nearly 195 degrees Fahrenheit (90 degrees Celsius). The tissue targeted at the focal point is destroyed, but tissue surrounding the targeted area remains unharmed.
Due to the Sonablate 450’s usage of ultrasound energy, and not radiation, the procedure may be repeated. The device can be used to perform prostate ablations that urologists routinely perform on prostate glands up to 40cc without previously performing a TURP (transurethral resection of the prostate) procedure. Tissue analysis is conducted via radio frequency (RF). An RF signal is sent to a targeted ablation site prior to delivery of HIFU and then another signal is sent after delivery of HIFU to the same site. The device calculates the change that took place and displays it on the screen. Tissue changes are quantified based on a comparison of RF ultrasound pulse-echo signals at each ablation site.
"The FDA's decision on Sonablate is an important step in providing men with prostate conditions access to this less invasive approach," said Neal Kassell, MD, chairman of the Focused Ultrasound Foundation, in a statement. "We hope that focused ultrasound will eventually become a standard of care for treating the prostate."
In those treated with Sonablate 450 (n = 100), 50% obtained local control of the disease, which was defined as a PSA nadir of 0.5 ng/mL or lower along with a negative biopsy at 12 months (97.06% CI, 0.39-0.61;P= .0206). In those with biopsy results at 12 months (n = 78), the local control rate jumped to 64.1% (97.06% CI, 0.52-076; P= .0001), which passed the bar for significance, which was set at a local control rate of 40%.
Grade I adverse events (AEs) related to HIFU were seen in 67.2% of participants. Grade 2 AEs were experienced by 81% and grade 3 AEs were seen in 23.3% of patients. The most common all-grade AEs were urinary tract infection (49.1%), incontinence (44.8%), urinary retention (41.4%), and hematuria (40.5%).
The most common grade ≥3 AEs, at 5.2% each, were stricture, which included urethral stricture and bladder neck contracture, and urinary tract infection. Severe incontinence related to the device was experienced by 3.4% of patients.
The combined fistula rate was 6.6% and 3 patients experienced osteomyelitis. After retaining on proper management techniques, the fistula rate dropped to 1.7% and there were no cases of osteomyelitis.
Larger studies are attempting to validate the efficacy and safety of Sonablate. Additionally, another HIFU device, Ablatherm, which is marketed by EDAP TMS, is undergoing a phase III clinical trial. Patient recruitment and follow-up phases of the study are now completed, according to the company. The pre-market approval file is currently under review by the FDA.
The positive decision for Sonablate 450 was preceded by a negative vote from the FDA's Gastroenterology and Urology Devices Panel in October 2014. At this hearing, the panel expressed desires to review further data on the HIFU device. Data reviewed by the FDA and its advisory panel were from the first 100 patients in a 200 patients trial. The mean age of patients in the trial was 69.7 years and the mean pretreatment PSA was 4.9 ng/mL.
"I believe that we are at a pivotal point in prostate care," said Michael Koch, MD, who was a clinical trial investigator and is chairman of the Department of Urology at Indiana University, said in a statement. "Simultaneous advances in imaging, fusion technologies, and now more focused therapies are going to allow us to precisely diagnose prostate conditions, and ablate these targeted areas rather than perform whole gland prostate surgery, which carries a significant burden on quality of life. HIFU will become the work-horse of subtotal prostate therapy."