Kate Johnson

May 11, 2016

SAN DIEGO, California — With the future of newly approved high-intensity focused ultrasound (HIFU) an open book in the United States, a late-breaking French study presented at the American Urological Association (AUA) 2016 Annual Meeting did little to shed light on the fate of the prostate treatment technology.

The multicenter study, funded by the French Urological Association, used HIFU to perform hemiablation of the prostate in men with low- and intermediate-risk cancer, adding yet another layer to the debate on how and when the approach should be used.

"Hemiablation is not true focal therapy, which involves treating just the focus of disease and a margin, so one must be careful with nomenclature," Nathan Lawrentschuk, MBBS, associate professor of urology at the University of Melbourne, in Australia, who is an outspoken critic of HIFU, told Medscape Medical News.

As reported previously by Medscape Medical News, Dr Lawrentschuk dismissed HIFU in a panel discussion at the AUA meeting "as a fringe treatment used in patients on the fringe of mainstream medicine."

But the French study, reported by Pascal Rischmann, MD, Rangueil University, Toulouse, France, reported that the procedure resulted in "excellent local control and a low morbidity profile" at 2 years.

An American clinician suggested that the technology may have a role in treatment, but that only time and data will tell.

The findings demonstrate that "hemiablation of the prostate can largely negate the side effects of whole-gland treatment," Michael Koch, MD, professor and chairman of the Department of Urology, Indiana University, Indianapolis, told Medscape Medical News. "It suggests that if these men are watched carefully, the vast majority can avoid radical treatment.... If its effectiveness approaches that of radical therapy, it is likely to become the preferred approach for appropriate patients."

Appropriate Patients

But the question is, who are appropriate patients?

The single-arm French study included 111 men whose median age was 64.8 years and whose median PSA level was 6.3 ng/ml.

Most of the men (74%) had a Gleason score of 6 or less; 26% had a Gleason score of 7.

At 2 years, the absence of clinically significant cancer on the treated lobe ― the primary outcome ― was documented in 95% of patients; 87% showed absence of any cancer in that lobe. In 67% of patients, the whole prostate gland was cancer free.

Radical treatment-free survival was 89% at 2 years. At 12 months, there was preservation of erectile function in 78.4% and preservation of urinary function in 97%.

"This study was conducted largely in men suitable for active surveillance [AS], so of course we would expect them to do well oncologically, but one wonders why they were actively treated with HIFU, which has complications," said Dr Lawrentschuk.

 
This study was conducted largely in men suitable for active surveillance. Dr Nathan Lawrentschuk
 

"One in five men developed erectile dysfunction [13.7%, severe; 7.8%, moderate], which is a concern in men who should largely have had active surveillance," he added.

Asked to comment on the appropriateness of patient selection for the study, Dr Koch acknowledged, "I don't think people who are good candidates for AS should be treated at all." When asked who is a good candidate for AS, he replied, "In general, I don't think patients with Gleason 7 should be treated with AS."

Dr Lawrentschuk said he believes men with a Gleason score of 6 should be followed with AS.

The French study was designed in 2008, "when we had a feeling that radical treatment was of questionable benefit for low- and intermediate-risk disease," said Dr Rischmann. Since then, active surveillance has largely filled that gap, "but still we had concerns regarding understaging, psychological burden, and delayed treatment," he said.

"Prostate gland hemiablation provides a reliable alternative to whole-gland radical treatment for selected patients with intermediate-risk cancer," he concluded.

Dr Lawrentschuck reported that he has never performed HIFU but has published about it. He has ties with AstraZeneca, Astellas, Amgen, Tolmar Ferring, and Jannsen.

American Urological Association (AUA) 2016 Annual Meeting: LBA-04, abstract 1150, presented May 9, 2016.

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