April 03, 2012 12:21 ET

U.S. Prostate Cancer Patients: Why No HIFU for You?

Dr. David Samadi, Leading Prostate Cancer Surgeon, Explains HIFU Risks and Why It's Not FDA Approved in the United States

NEW YORK, NY--(Marketwire - Apr 3, 2012) - Among the myriad of prostate cancer treatment options, High Intensity Focused Ultrasound (HIFU) uses sound waves to heat and destroy diseased prostate tissue. While an increasing number of practices promote HIFU, the experimental prostate cancer procedure is not FDA approved in the United States. Dr. David Samadi, Vice Chairman of the Department of Urology and Chief of Robotics and Minimally Invasive Surgery at Mount Sinai Medical Center, expressed concern about how HIFU is marketed.

"HIFU is in its infancy when it comes to prostate cancer in the United States," said Dr. Samadi. "We know very little about the safety, efficacy, and long-term effects of the procedure." Dr. Samadi discussed how HIFU, which requires men in the U.S. to travel to another country for the procedure, is positioned to patients. "You see websites promoting HIFU and very often the benefits of the procedure are interwoven with the benefits of a great vacation in the Bahamas, for example. They're blurring the lines of patient focused, proven medical care with travel and leisure. I don't think this is the message that we should be sending to men with life threatening cancer."

The Sonablate® 500 is the preferred machine for HIFU prostate cancer procedures. While the technology is roughly a decade old, reports indicate that fewer than 10,000 procedures have been performed globally. Using a rectal probe, the doctor directs an ultrasonic beam at the cancerous tissue, which is later expelled naturally.

Why Isn't HIFU FDA Approved?
HIFU's success rate pales in contrast to robotic prostatectomy surgery. Having performed nearly 4,000 successful prostate cancer removal surgeries, Dr. Samadi has a 97 percent cure rate with his SMART technique (Samadi Modified Advanced Robotic Technique) and proper adherence to post-operative and follow-up care. With HIFU, 87 percent of patients have a negative biopsy six months after the procedure. Dr. Samadi believes the FDA's reluctance to approve HIFU for prostate cancer is based on limited data and a long list of possible risks that need to be tested.

"With HIFU, no one's talking about what happens 10-20 years post-procedure because they just don't know," says Dr. Samadi. "What we do know about side effects can be rather severe."

The Truth About Prostate Cancer Treatment with HIFU

1. Missing Expertise
Similar to radiation, HIFU treatment is based on PSA, biopsy, and CT scan data to determine the prostate cancer tumor's size, shape, and location. While Dr. Samadi uses these same diagnostic tools, his expertise in removing prostate cancer is fortified by first hand knowledge. The cancer's impact on the prostate, the seminal vesicles, and the lymph nodes is not clear until visualized during surgery. "In fact," he says, "a staggering 40 percent of prostate cancer stages are refined with tumor analysis after surgery."

Further, HIFU is praised as "click of the mouse" technology, a dubious concept according to Dr. Samadi. "Robotic surgery is highly advanced," he says, "but technology cannot replace expertise. When I hear people talk about the machine doing all the work or the need to simply click a button, I get very concerned."

2. A Partial Solution
Many HIFU experts tout the repeatable nature of the procedure as if it's a selling point. "What man wants to repeat prostate cancer treatment? If you read between the lines," said Dr. Samadi, "they're saying the procedure often needs to be repeated. That's simply not the case with the majority of my robotic surgeries."

3. HIFU Treatment Risks
The list of HIFU risks is fairly long. Accounts vary, though erectile dysfunction seems to occur in as many as 30 percent of patients in the year following HIFU; that's double the risk Dr. Samadi's patients face. Urinary continence is restored in roughly 88 percent of HIFU patients, while 96 percent of Dr. Samadi's patients regain urinary control one year post-surgery.

Prostate infection, rectal wall injury, rectal incontinence, ejaculation problems, and prostate cancer recurrence are among the many additional HIFU risks.

With his diligent attention to post-surgery care and optimal outcomes, Dr. Samadi's SMART surgery gives patients the quality of life they deserve. "Many international men come to me for SMART prostate removal surgery," says Dr. Samadi. "But U.S. men who travel overseas for experimental surgery are selling themselves short. We have the finest prostate cancer specialists and the most effective, advanced treatment options available right here."

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