Prostate Cancer HIFU Still Not FDA-Approved

Dr. David Samadi, leading robotic surgeon, discusses experimental HIFU focal therapy for prostate cancer

New York, New York, UNITED STATES

New York, NY, March 21, 2013 (GLOBE NEWSWIRE) -- The makers of HIFU (High Intensity Focused Ultrasound) have announced the launch of Focal.One, an enhancement to their robot-delivered ultrasound therapy for prostate cancer. The focal therapy combines MRI tumor analysis with a targeted ultrasound beam. Despite these advancements, Ablatherm® HIFU is still not FDA-approved for use in the United States, said Dr. David Samadi, Vice Chairman of the Department of Urology and Chief of Robotics and Minimally Invasive Surgery at Mount Sinai Medical Center.

Currently, the makers of Ablatherm ® HIFU, EDAP TMS, recommend the treatment for patients with localized prostate cancer in stages T1-T2 who are not considered candidates for prostate surgery or do not wish to have surgery. It is also recommended for those who had unsuccessful radiation for prostate cancer.

The primary data featured on, a website by Ablatherm® HIFU, describes a 10-year study of only 12 patients who underwent HIFU treatment in France. While no metastases were reported, almost half of the patients required a repeat procedure five years post-treatment.

For Dr. Samadi, however, HIFU limitations are about much more than newness or minimal data. "In my opinion, robotic prostate surgery is the only way to remove the cancerous prostate and conduct tumor analysis with absolute certainty," he stated.

A HIFU treatment plan is designed using CT scans and biopsy results, as well as in-procedure ultrasound imaging. While Dr. Samadi's pre-surgery diagnostics are similar, robotic prostatectomy is vastly different from HIFU. First, HIFU does not remove the prostate. Second and most critically, according to Dr. Samadi, HIFU ultrasound imaging does not provide firsthand visualization of the degree of cancer in the prostate, seminal vesicles, or lymph nodes. As a result, partial treatment and recurrence may be more likely.

Beyond prostate cancer recurrence, potential HIFU risk factors include prostate infection, rectal wall injury, rectal incontinence, and ejaculation problems. Some long-term or short-term side effects are associated with all prostate cancer treatments, which is why Dr. Samadi stresses the importance of provider expertise in optimizing outcomes.

"Align yourself with a prostate cancer expert who will accurate and objectively recommend a targeted approach. Once you decide on a treatment plan, seek the most experienced provider," advised Dr. Samadi, who has performed more than 4,500 successful robotic prostatectomies using the da Vinci Surgical System robot. His patient recovery data includes a resumption of sexual potency in 85 percent of patients and urinary continence in 96 percent of patients.

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