Does HIFU have a future in the U.S. for treating prostate Ca?

“I try to keep abreast of ultrasound; I do ultrasound in my office and frequent transrectal ultrasound-guided needle biopsy, but I don’t believe the technology and delivery of the energy of HIFU is going to succeed. I think some good recent literature supports that, but it is being pushed on an international level by some powerful people. I’ve gone to meetings and taken courses on this, but I haven’t even considered getting geared up to do HIFU.

Ultrasound implies focus, but ultrasound cannot see prostate cancer. In the hundreds of anatomic prostatectomies I’ve done, there are almost always sites not appreciated by the biopsies because you can’t see carcinoma of the prostate with ultrasound. So the idea of being able to use focused microwave to somehow eradicate the disease is counter to my experience and knowledge of the pathology of prostate cancer.”

Lyle Griffith, MD

Hanford, CA

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“I was involved with the FDA registration studies examining the safety and effectiveness of salvage HIFU using the Sonablate 500 (SonaCare Medical) following radiation therapy for localized prostate cancer. I think the fundamental question really is, will ablative technology in general play a role in prostate cancer treatment?

Ablative energy can be used three ways to treat prostate cancer. One is to attempt to eradicate the entire prostate in men presenting with localized prostate cancer when whole-gland treatment is indicated. Personally, I don’t feel ablative techniques reliably destroy the entire gland, and in this setting the prostate should be removed via radical prostatectomy. Second, when radiation therapy has failed and we believe the disease recurrence is localized, the option is to do a salvage prostatectomy-a technically simple procedure that is fraught with significant complications. In this setting, doing a salvage HIFU, or any ablation, makes sense.

The third is focal therapy. Prostate imaging using multi-parametric MRI identifies the dominant disease fairly reliably. Today, we remove only the cancerous component of the kidney and breast; why not ablate only the “clinically” significant prostate cancer? Therefore, focal ablative therapy using HIFU may prove to be an attractive way to manage select cases of localized prostate cancer.

I’m a strong believer that focal therapy will ultimately have a role in treating prostate cancer. It won’t replace whole-gland treatment in all cases, but a subset of patients exists where disease control will be satisfactory with ablation, minimizing the side effects of incontinence and erectile dysfunction. When we talk about focal or targeted therapy, HIFU will appear to be a very reasonable energy source. I get the sense HIFU may be easier to control than freezing, but time will tell. For salvage treatment following failed primary radiation or focal ablation, HIFU appears to have the properties to be an effective option.”

Herbert Lepor, MD

New York

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“Patients will go out of the country to get a treatment like HIFU, but unless it obtains FDA approval, it can’t become a mainstream treatment in the U.S. Trials are ongoing, but I’m not aware of any data indicating that approval is imminent.

If it were to gain approval, I think it would get some use. You can equate it to cryotherapy, which is FDA-approved ablation therapy for prostate cancer. I don’t think it would replace surgery or radiation, but it would have a similar uptake to cryo because it profiles somewhat similarly to cryo. It’s a way to ablate the tissue with fewer complications, at least in theory.

The current model of sending a patient to Canada or Bermuda, or wherever, I don’t think that’s sustainable.

I also think people may use it as an alternative to active surveillance, which I’m not certain is necessarily the right thing to do, because a lot of patients and doctors are not comfortable with active surveillance and they want to do something. So I think you will see limited treatments such as cryo and potentially HIFU as a way for patients to deal with what might not be high-risk disease.”

David F. Penson, MD, MPH

Nashville, TN

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