HIFU: Promising therapy merits clinical trial participation

August 1, 2008

Outside of the United States, technology for HIFU is available from two companies. HIFU is being used as primary treatment for men with small prostates and low-stage, low-volume disease, particularly in those who are not good candidates for conventional treatments because of their age or comorbidities. It is also being used as salvage treatment after failure of radiation therapy.

HIFU has not been FDA-approved for use in the United States. However, at least two phase II/III clinical trials are currently under way in this country, and the investigational sites include several academic-based centers of excellence.

Outside of the United States, technology for HIFU is available from two companies. HIFU is being used as primary treatment for men with small prostates and low-stage, low-volume disease, particularly in those who are not good candidates for conventional treatments because of their age or comorbidities. It is also being used as salvage treatment after failure of radiation therapy.

In this country, there has been a disturbing phenomenon in which HIFU has become an object of "medical tourism." Reportedly, at least one manufacturer of this technology is enticing doctors to refer or to accompany their patients to be treated at an offshore site. The incentive for physicians is said to be a fee of up to $7,500 per referral, while patients are paying $25,000 to $30,000 out of pocket for the treatment. This practice is not only inappropriate, as the efficacy of HIFU relative to known curative modalities has not yet been proven, but it is frankly unethical and should be condemned because physician remuneration should not be the guiding principle for determining therapy. Furthermore, it casts a negative shadow over HIFU that may bias urologists against this modality before its merits and limitations can receive a fair and critical assessment based on results of rigorously conducted clinical trials.

The future of HIFU in the United States depends on completion of these clinical trials. Current data about this modality are intriguing and provide substantial reason to expect that HIFU may find a future role in prostate cancer treatment. I encourage American urologists to refer appropriate patients for possible participation in ongoing studies within the United States so we can obtain the data necessary for FDA to make that determination.

Dr. Williams, a Urology Times editorial consultant, is professor and chair, department of urology, University of Iowa, Iowa City.