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Jim Hu, M.D. Men diagnosed with prostate cancer in the United States now have another treatment option: high-intensity focused ultrasound (HIFU). However, the jury is out in terms of the effectiveness of the treatment, according to Weill Cornell Medicine researchers. In a paper published June 28 in JAMA, they recommend that registries should be created to generate the data and evaluate cancer control and safety.

HIFU is a technique that blasts high-frequency ultrasound waves through the walls of the rectum, generating enough thermal energy to destroy prostate tissue. HIFU is designed to kill prostate cancer cells while keeping the gland intact, thus preserving urinary and sexual function. These benefits led prostate cancer survivors to liken the device to a "promise from heaven" at a recent U.S. Food and Drug Administration-sponsored workshop about HIFU, the authors noted in their paper.

"But this is still new," said lead author Dr. Jim Hu, the Ronald P. Lynch Professor of Urologic Oncology and a professor of urology at Weill Cornell Medicine, as well as a urologic oncologist at NewYork-Presbyterian/Weill Cornell Medical Center. "Although I believe that this therapy will be useful for some men preferring to avoid treatment of the entire prostate, it remains to be seen what the ideal patient and tumor characteristics are for HIFU."

While the FDA recently approved this form of treatment, which has been called a lumpectomy for men, for tissue ablation, HIFU has failed to gain approval as a treatment for prostate cancer. As a result, insurers won't cover HIFU, costing men who are treated with it approximately $25,000 out of pocket.

"There's a lot of enthusiasm related to this technology. But the lack of data — particularly comparative information — is a major hurdle for regulatory and payment decisions," said co-author Dr. Art Sedrakyan, a professor of healthcare policy and research at Weill Cornell Medicine. Medicare and health insurance, for example, will not reimburse for HIFU unless the FDA specifically approved it for treating prostate cancer.

The authors examined studies conducted in the United Kingdom that assess HIFU's efficacy and found that only 50 percent of men achieved continence and potency preservation with the absence of cancer. But Dr. Hu says it's difficult to make head-to-head comparisons, as European men are often diagnosed with prostate cancer at later stages than those in the United States.

They also found that despite HIFU having a lower estimated cost compared to alternate treatments, such as robotic-assisted radical prostatectomy, its costs would most likely increase over time due to treatment failure, which could lead to repeat HIFU procedures and ultimately a switch to external radiation therapy or surgical treatments. However, "some men may find value in using HIFU to focally treat areas of prostate cancer and delay surgical or whole gland irradiation, which have greater risks of erectile dysfunction and urinary incontinence," Dr. Hu noted. "Additionally, men diagnosed with slow-growing cancers may find that HIFU is an ideal treatment to alleviate significant distress and anxiety. We know that a prostate cancer diagnosis is associated with depression and worse mental health and HIFU may alleviate these concerns."

"Our specific recommendation is that we need a registry where clinicians could contribute data, and this would allow us to do real-life evaluation of short-term and long-term outcomes," Dr. Sedrakyan said. Drs. Hu and Sedrakyan as well as partners from the Food and Drug Administration and the device manufacturers are hosting a meeting at the FDA on July 22 to develop a registry consisting of academic and community centers nationally.