HIFU in Prostate Cancer: Are Patients ‘Guinea Pigs’?
Gerald Chodak, MD
Disclosures | March 03, 2016
Hello. I’m Dr Gerald Chodak for Medscape. Today I want to talk about high-intensity focused ultrasound (HIFU), which was approved in November 2015 for ablating prostate tissue. By way of history, in 2014, a US Food and Drug Administration (FDA) panel concluded that HIFU was not adequate as a treatment for localized prostate cancer. That conclusion was based on an attempted randomized trial comparing HIFU with ultrasound. That study did not have adequate accrual, and yet, in the men getting treated with HIFU, 28% had a positive biopsy at 2 years.
Fast forward a year, and now the approval states that it can be used for ablating prostate tissue. I’m not exactly sure what that means in terms of using it to treat men with prostate cancer, but the concern here is that it may be mismarketed or misrepresented by clinicians who use HIFU. A question, of course, will be who is going to pay for it and under what pretenses that will occur. The FDA concluded that it was a safe treatment for ablating prostate tissue.
Although the short-term markers are not an indication of long-term effectiveness, by giving it this approval, they have indicated that the companies can accrue more data to look for efficacy. In other words, it means that patients are going to be guinea pigs in an experimental assessment of this treatment without really realizing that they’re going to be experimented on for that purpose.
I’m extremely concerned about this approval process because it looks like a backdoor way to get the opportunity to use HIFU in men who have localized prostate cancer. But the real question is, is it good enough? In previous commentaries that I’ve done, HIFU has not held up well against other treatments for localized disease. In fact, it seems to work best in men who least likely need to be treated.
One has to wonder why the FDA took this approach and whether they are going to caution the company about how it’s going to be marketed. Clearly, it cannot be marketed as a treatment for prostate cancer, so under what circumstances would one want to use it in men with prostate cancer who need to get treated for their disease?
We’ll have to wait and see how this unfolds and whether Medicare and other payers will decide to pay for it when a man has a diagnosis of prostate cancer. For now, I’m concerned. Hopefully, things will bear out so that patients are protected and not led to believe that HIFU is as good as other therapies for localized prostate cancer in men who really need to be treated. I look forward to your comments. Thank you.
Largest Series to Date Finds HIFU Effective for Localized Prostate Cancer
By Anne Harding, October 21, 2016
NEW YORK (Reuters Health) – Hemiablation with high-intensity focused ultrasound (HIFU) appears to be an effective treatment for patients with unilateral localized prostate cancer, and preserves erectile function and continence in most patients, according to a new report.
The multi-center study in 111 patients is the largest study of HIFU-hemiablation published to date, with the longest follow-up, Dr. Pascal Rischmann of Rangueil University Hospital in Toulouse, France, told Reuters Health in a telephone interview. The findings were published online October 7 in European Urology.
Active surveillance (AS) is the preferred option for patients with low-risk disease and radical prostatectomy is indicated for high-risk patients, but options for prostate cancer patients who fall in between have been limited, Dr. Rischmann noted.
Focal treatment with HIFU for patients with localized disease offers the option of “sparing the prostate without burning the bridge for other treatments,” he explained. “If this management fails, you can do radical prostatectomy if the patient is not too old, and if he is older then you can do radiation.”
The French Urological Association initiated the new study, which was conducted in 10 different French centers from 2009 to 2015. Control biopsies were available for 101 of the 111 study participants. Average follow-up was 30.4 months.
Among the patients with a control biopsy, at one year after treatment, 95% had no clinically significant cancer in the treated lobe, while 93% were free from clinically significant cancer in the untreated lobe. Mean PSA was 6.2 ng/ml at baseline, and 2.3 ng/ml at two years after treatment.
Radical-treatment-free survival was 89% at two years. The radical treatments included six prostatectomies, three radiotherapies, and two HIFUs. Thirteen percent of patients had grade 3 adverse events.
At one year, 97% of patients had preserved continence, while 78% had preserved erectile function, and there was no decrease in quality of life at one year.
Ten U.S. centers offer HIFU for prostate cancer, Dr. Rischmann noted, but second-generation HIFU technology is not yet available in the U.S. The device used in the study, the Focal One from EDAP TMS, makes it possible to evaluate treatment during the procedure using contrast-enhanced ultrasound, he said.
He and his colleagues conclude: “The efficacy of HIFU partial prostate gland therapy should be evidenced by comparative studies conducted versus standards of care.”
The researchers reported no funding. Dr. Rischmann owns stock in EDAP TMS and is a consultant for the company, as are several of his co-authors.
Eur Urol 2016.