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Treatment for Prostate Cancer
Physicists and engineers at Indiana University School of Medicine pioneered high intensity focused ultrasound (HIFU) in the 1970s. Through continued work, urology researchers at the school helped advance this treatment. The first HIFU research protocol was developed at Indiana University School of Medicine with current department of urology chair Michael Koch, MD and professor of urology Thomas Gardner, MD contributing.
HIFU is a focal treatment for prostate cancer that allows precise application of heat to destroy cancer tissue. A probe is placed in the rectum for treatment, and high-energy ultrasound waves are focused on the prostate, which is 1-4 centimeters away. Importantly, the intervening tissue including the rectum is not heated. The treatment is radiation free and does not require incisions.
Aggressive or large prostate cancers are best treated with surgical removal or radiation, but smaller or less aggressive cancers are good candidates for treatment with HIFU. Some advantages of focal HIFU treatment include lower rates of urinary leakage (incontinence), better erectile function outcomes, and the ability to go home the same day. A urinary catheter may still be needed for a couple days, but this is less than the week typically required by surgical removal of the prostate.
While the device was approved in 2015 in the USA, the technology was pioneered at Indiana University School of Medicine in the 1970s with the first HIFU device for treatment of prostate cancer being built in Indianapolis in 1996. On April 26, 2000 a cancer symposium was held at Indiana University School of Medicine where the first research protocol was crafted for HIFU prostate treatment in the United States. Participants included Dr. Koch and Dr. Gardner as well as researchers from University Hospital Cleveland, Wake Forest University, University of Bern, University of Vienna and University of Amsterdam, among others.
In 2007, Dr. Koch with others at IU School of Medicine published on the first 20 patients treated with HIFU in United States [Koch MO, Gardner TA, Cheng L et al. Phase I/II Trial of High Intensity Focused Ultrasound for the Treatment of Previously Untreated Localized Prostate Cancer. J Urol. 2007 Dec;178(6):2366-70.]. The study showed the treatment had few side effects and had the potential to be an effective treatment option for early-stage prostate cancer. They found that ablation of the whole gland can cause temporary swelling and the need for a temporary urinary catheter. This increased the interest in focal or partial-gland ablation. Subsequent studies on HIFU partial gland treatment have demonstrated preservation of erections in close to 90% and a 100% pad-free rate by three months.
The first HIFU system (Sonablate®) was manufactured in Indianapolis in 1996 for a company called Focus Surgery. SonaCare Medical, LLC was established in 2013. Sonablate® became the first device approved by the FDA for HIFU in 2015.