The High-Intensity Focused Ultrasound treatment, or HIFU, directs acoustic energy into the body and destroys cancerous cells in the prostate.
It was developed by George M. Suarez, M.D., F.A.C.S., F.A.A.P., a Board-certified urologist and a former faculty member of the University of Miami Department of Urology.
“I became interested in the HIFU technology back in 2001,” Suarez told WND in a telephone interview. “The technology was first used in 1999, in Europe. While the technology has been approved for medical use in Europe for some 15 years now, when I first became interested in the technology, it did not have FDA approval here in the United States.”
Winning FDA approval
Initially, Suarez opened up an HIFU facility to bring his prostate cancer patients to the Dominican Republic, where a friend who was a prominent university-affiliated urologist offered to assist him.
Within the first month of offering the innovative treatment overseas, Suarez and his team treated more than 20 patients and maintained a similar volume over the next few years.
Initial outcomes were extremely positive, with Prostate Specific Antigen, a protein present in the bloodstream produced by prostate cells, nadirs indicating a favorable treatment of the cancer, equivalent to radical surgery or radiation.
While outcomes were comparable to standard methods, it quickly became evident that potential side effects with HIFU were significantly lower. Suarez noted a significantly decreased risk of impotence from 80 percent to 2 percent and from 20 percent to a mere 0.4 percent in urinary issues, such as incontinence.
In 2003, Suarez established the first HIFU facility in North America at the Universidad Madre y Maestra, Santiago, Dominican Republic, a private, Catholic medical school owned and operated by the Vatican.
He subsequently established similar HIFU facilities throughout Canada, Mexico, South America and the Caribbean, all countries in which HIFU was approved, based on European CE-marking approval that dates back to 1996. Creating International HIFU Centers allowed both American and other prostate cancer patients the opportunity to receive the treatment.
“The FDA approval took a long time because the truth is the FDA had never done clinical trials for prostate cancer treatment,” he explained. “The FDA simply grandfathered into approval the treatments for prostate cancer available before 1977, the date when the FDA began expanding beyond merely sanctioning medications to also sanctioning medical devices.”
Suarez then worked with the FDA and designed the clinical trials required to test the use of HIFU technology to treat prostate cancer, not only for primary cases, but also for radiation recurrence patients.
Finally, on Oct 9, 2015, after spending more than $250 million to complete the clinical trials, the FDA officially approved HIFU as a medical treatment for prostate cancer.
Today, Suarez, who has now treated several thousand patients over the past 13 years, is widely known as the pioneering urologist who spearheaded the HIFU clinical trials with the FDA and is acknowledged as the foremost expert in the United States on the HIFU procedure applied to the treatment of prostate cancer.
‘An amazing technology’
“It’s an amazing technology in that unlike surgery or radiation, with HIFU a doctor can now determine the targeted cancer area that requires treatment and visualize the vital structures necessary for preserving quality of life,” said Suarez.
“This means we can work around and maintain the neurovascular bundles that are responsible for preserving sexual potency in a man, or the external sphincter that preserves urinary continence, extremely life-altering side effects that can compromise a man’s quality of life,” he explained.
“For a woman losing a breast to cancer is a horrible thing. For a man, it’s a horrible thing to come out of prostate surgery and to have to wear a diaper or to become impotent,” he said. “At the end of the day, erectile dysfunction and urinary incontinence remain the most feared potential complications common to surgery and/or radiation in patients treated with standard prostate cancer therapy.”
The website for his Prostate Cancer Institute describes how his HIFU treatments for prostate cancer utilizes the state-of-the art Sonablate-500 HIFU device.
The machine allows imaging and precise delivery of HIFU energy to the prostate. The neurovascular bundle can be detected via an embedded ultrasound Doppler that permits a potency-preserving HIFU treatment of the minimum amount required.
The Sonablate-500 technology destroys cancer cells in the prostrate by focusing ultrasound energy, or sound waves, on the cancer cells. At a temperature of nearly 195 degrees Fahrenheit, the ultrasound energy destroys the targeted tissue while leaving the tissue located outside of the focal lesion unharmed.
“The HIFU treatment for prostate cancer also has the advantage of being an outpatient procedure that generates absolutely no pain,” Suarez said. “The most amazing thing is the patient can go home about an hour after the procedure is done and out on the golf course the next day playing 18 holes, something unimaginable with typical prostate cancer surgery.” said Suarez.
The outcome of the procedure is determined by measuring the PSA with a simple blood test, and the result is typically “zero.” A successful procedure results in PSA being undetectable for about a month.
“In other words, for our typical patient, the HIFU procedure is successful and the targeted prostate cancer is removed,” Suarez said.
Common cancer in American men
Other than skin cancer, prostate cancer is the most common cancer in American men, with the American Cancer Society estimating about 220,000 new cases are diagnosed each year. About 27,500 deaths from prostate cancer are reported each year. The disease is expected to affect one man in seven during his lifetime, the ACS says.
HIFU now allows doctors in the United States to provide their patients this viable treatment option.
“The fact is that the evolution of surgery is toward any and everything that is non-invasive. Like any new therapy, there is a proficiency learning curve. I am most impressed with the rapid adoption of HIFU by urologists worldwide, and particularly in the United States,” said Suarez.
“Now, with HIFU, we have an alternative where the treatment is so benign and so non-invasive that now we can treat even slow-growing prostate cancers in older men,” he said.
“Dr. ‘Bones’ McCoy, the character in the ‘Star Trek’ television series, dreamed of the concept of one day being able to perform surgery deep into the body without as much as a scalpel or an incision,” Suarez said in conclusion. “With the advances in HIFU for prostate cancer, those dreams are now a reality.”