Editor’s note: HIFU was approved for use by the FDA in 2015.
The use of High Intensity Focused Ultrasound (HIFU) waves to treat prostate cancer without surgery on an out-patient basis moves closer to U.S. approval thanks to Dr. Michael J. Lazar, Jr. and other urologists utilizing this next-generation technology with patients in other nations.
There is a new treatment option for patients with prostate cancer that is confined to the organ, and not spread to other areas of the body. HIFU is a minimally invasive, out-patient, and radiation-free procedure that patients can undergo in a few hours and return home the same day. This advancement in the treatment of prostate cancer is making it possible for patients with earlier stages of the disease to maintain their quality of life without surgery. Even if the prostate cancer returns, no matter what form of treatment was previously used, HIFU can be used again for localized treatment. The use of HIFU also does not rule out other treatment options for recurring cancer.
HIFU technology achieves pinpoint accuracy using an “acoustic scalpel” that destroys prostate cancer, while sparing healthy tissue and preserving nerves, urine flow and erectile function in a majority of cases compared with traditional procedures.
U.S. Food and Drug Administration (FDA) approval of HIFU is expected following a study involving 100 men with prostate cancer recurrence after radiation. HIFU is eradicating cancer in 70 to 72 percent of these cases, compared with cryosurgery (freezing) that historically cures about 40 percent. HIFU success rates are higher in men with previously untreated cancer. The next step will be to seek a U.S. extension of the new HIFU process to non-radiation patients.
“Twenty years ago I attended a lecture sponsored by the American Urological Association telling us that HIFU would be the future for our profession. Now we are on the brink of seeing this procedure accepted,” said Dr. Lazar, an adult and pediatric urology specialist with Northern California Medical Associates, and principal of California HIFU with offices located at 1140 Sonoma Avenue, Suite A, in Santa Rosa.
Prostate cancer is the second leading cause of cancer death in American men behind lung cancer. The American Cancer Society estimated that about 238,590 new cases of prostate cancer would be diagnosed in 2013 and about 29,720 men would die of this disease. Approximately one man in six will be diagnosed with prostate cancer during his lifetime, and one in 36 will die as a result. Prostate cancer is rare before age 40. The average age at the time of diagnosis is about 67.
“The oncological results for HIFU are broadly comparable to radical surgery or radiation but the side effects are less, especially with regard to incontinence and erectile dysfunction. There is almost no pain or blood loss. The treatment is quick and virtually painless following spinal or general anesthesia that wears off in just a few hours,” Dr. Lazar said. “If the procedure is performed in the morning, a patient is typically up and around by dinnertime and can often return to normal activity within a few days without the use of pain killers.”
HIFU patient testimonial
Temple Smith, one of Dr. Lazar’s patients, knew that prostate cancer ran in his family. His uncle died of it and his twin brother also had it. His brother underwent a prostatectomy that kept him in bed three to four days, and today he is incontinent.
“When I was diagnosed with prostate cancer, I had the HIFU procedure. Last October marked my fifth anniversary after having this treatment and there has been no cancer recurrence. If you have prostate cancer and the resources to get the HIFU treatment, get it done,” Mr. Smith said.
According to Dr. Lazar, HIFU is the only non-radiation technology that requires no direct contact with the target organ while accurately zeroing-in on selected portions or destroying the entire gland. No other form of treatment gives a surgeon such precise control without damaging surrounding tissue aided by simultaneous ultrasound visual tracking.
Other prostate cancer treatment options include radical surgery, radiation, hormonal and chemo/immunotherapy. Besides the usual risks of incontinence and erectile dysfunction, radiation can cause chromosomal changes that result in cancer of the bladder and rectum.
Dr. Lazar has performed approximately 100 successful HIFU procedures on patients who volunteer to fly south of the border. “Most months for the past seven years I have traveled to Puerto Vallarta for a long weekend of outpatient procedures at a U.S. Joint Commission approved bilingual hospital. I also serve as an HIFU instructor, am one of three FDA study proctors and have aided other doctors who have treated over 200 patients to date.”
In the Western Hemisphere, the HIFU procedure is also conducted in Bermuda, Canada, Cancun and Nassau. Some 15 years of data have been compiled from Japan, 10–12 years from the UK/Germany/Italy, and nine years from Canada focusing on the HIFU procedure and results.
Another patient of Dr. Lazar is San Francisco business owner Harlow Plimpton, who had the HIFU procedure in 2011. “Before the therapy my PSA level was between 6 and 7. Following the treatment my PSA dropped to 0.1. I did not experience any side effects or incontinence. I went to the Puerto Vallarta clinic at 7:30 a.m. and walked out three to four hours later to tour the city. The doctors offered me Cialis and Viagra, but I didn’t need it. Since then I’ve been looking for a downside, but frankly, I haven’t found any.”
The HIFU procedure costs approximately $25,000, compared with robotic prostatectomy and some forms of radiation therapy that can range in cost from $40,000 to $60,000. While a few U.S. insurance companies have covered HIFU, coverage is sporadic at this time.
Within the U.S., the American Medical Association creates Current Procedural Terminology codes (CPT) for doctors to use for billing and insurance purposes. As yet, no CPT code has been established for HIFU. “Meanwhile I tell my patients the cost is like buying a car, and many take out a home equity loan which may be tax deductible,” Dr. Lazar said.
Dr. Lazar has been certified by SonaCare Medical, LLC, a global leader in minimally invasive HIFU technologies, based in Charlotte, North Carolina. SonaCare Medical, through its subsidiary Focus Surgery, Inc., of Indianapolis, manufactures HIFU systems, such as Sonablate®. The Sonablate unit is approved for investigational use only in the United States until the expected FDA approval. However, it is already being used in over 30 countries outside the U.S. for the treatment of prostate cancer.
“My advice to those diagnosed with prostate cancer is to seek medical counsel on all options, not just surgery or radiation, so you can make an informed decision and see if you are a candidate for HIFU,” he added.
Michael J. Lazar, MD, graduated from the University of Arkansas in 1978 and completed postgraduate training in surgery and urology at LSU in 1983. He is four-time board certified by the American Board of Urology and is Managing Physician Director of Santa Rosa Surgical Management Co., LLC, which manages Santa Rosa Memorial Hospital’s Ambulatory Surgery Center. He is also Chairman of the Board of Directors of Redwood Health Services and is a member of the American Urological Association.