The FDA has announced its conditional approval, pending minor changes to the protocol, for a clinical trial for the treatment of recurrent prostate cancer with the Sonablate(R) 500 (HIFU) in men who have failed external beam radiation therapy.
Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine will serve as the medical monitor for the trial. He stated, “I have personally reviewed the preliminary data and observed the Sonablate(R) 500 in action and I am impressed with this advanced technology for ablating the prostate. These rigorous clinical trials will help define the appropriate role of the Sonablate(R) 500 device in the treatment of prostate cancer.”
This trial will be a multi-institutional site trial with sites from across the U.S. anticipate enrolling approximately 202 subjects at 10 separate clinical centers. There was a feasibility trial (phase I/II) that was completed in October 2007 that had enrolled 11 subjects from two clinical research sites. The results of this feasibility trial provided a basis for this phase III trial. Additional studies are still needed to satisfy the safety and effectiveness standards, including long term outcomes, set by the FDA for marketing approval.
The Sonablate(R) 500, nor any HIFU equipment are not currently approved for use in the U.S. The Sonablate(R) 500 remains investigational in the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. FDA has made no decision as to the safety or efficacy of the Sonablate(R) 500 for the treatment of prostate cancer.
What is HIFU?
High Intensity Focused Ultrasound, or HIFU, is a therapy that destroys tissue with rapid heat elevation, which essentially “cooks” the tissue. Ultrasound energy, or sound waves, are focused at a specific location and at that “focal point” the temperature raises to 90 degrees Celsius in a matter of seconds causing the targeted tissue to be ablated. HIFU does not use any radiation and may be repeated if needed.
Currently HIFU is approved and is being used in many locations, including Mexico and Germany.
Joel T Nowak MA, MSW