High-intensity focused ultrasound for prostate cancer: Is it ready for prime time?

HIFU uses ultrasound to induce tissue damage by thermal and mechanical effects and cavitation. It requires general or spinal anesthesia, and based on the size of the gland, can be time consuming, with about 10 grams of tissue treated per hour. While generally safe, HIFU is not devoid of side effects, with erectile dysfunction, strictures, urinary retention, incontinence, and urinary tract infections reported.

HIFU is approved and has been available in many European countries and Canada for several years. However, in addition to minimizing potential side effects, there are challenges in interpreting the oncologic outcome in treated patients. As noted by the European Association of Urology (EAU), no international consensus on objective response criteria exists. Some authors have adopted the parameters used for radiation therapy, but this is not universally accepted. In 2011, the EAU classified HIFU as "experimental or investigational." In the U.S., HIFU therapy is only available through a clinical trial.

Defining HIFU's optimum patient characteristics, agreement on the definition of oncologic outcomes, refining its technical aspects, and achieving FDA approval remain considerable challenges. While progress is being made, it remains uncertain if and when HIFU will be available in the U.S. and accepted internationally as a standard of care.

Leonard G. Gomella, MD

Dr. Gomella, a member of the Urology Times Editorial Council, is chairman of the department of urology and associate director of clinical affairs, Jefferson Kimmel Cancer Center, Thomas Jefferson University, Philadelphia.