New High Intensity Focused Ultrasound Minimally-Invasive Treatment for Prostate Cancer Pioneered by Dr. Michael Lazar Soon to Be Approved by FDA for Use in the U.S.
The use of a new technology called 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.
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.”
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 HIFH 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, M.D. 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.
It has been very exciting to be able to offer HIFU to men with prostate cancer the past 6 years. The utility of the procedure continues to grow, with the evolution from merely whole gland therapy to the possibility of focal therapy. With MRI imaging improvements, we can not only limit treatment to the cancer focus in appropriate men, we can now better determine which patients are likely to have successful outcomes with whole gland therapy. Tissue Change Monitoring (TCM) has inspired me to modify the treatment on whole glands to lessen the risk of complications.
It is impressive that many of my patients have done the math and found HIFU to be a relative bargain due their ability to go right back to work. When one considers the convalescent period after radical prostatectomy, or the weeks involved with radiation therapy, not mention the higher side effect profile with both, the cost of HIFU becomes less an obstacle to choosing this innovative option. I am very enthusiastic about teaching this procedure to my colleagues going forward.
To learn more about or be connected to Dr. Lazar please call 1-866-553-1629 or email email@example.com.
Patients diagnosed with prostate cancer are faced with treatment options. The historical
remedies—radiation therapy, surgery, hormonal therapy, chemotherapy and freezing the cancerous gland—have risks and negative side effects, especially incontinence and impotence. A new technology, however, is coming of age in its ability to diminish these risks and side effects. This nonsurgical outpatient option—high intensity focused ultrasound (HIFU)—takes approximately one to four hours to perform, depending on prostate
size, and has a relatively short recovery period.
With HIFU, most patients are up and walking around within two to three hours and may resume normal activities within a couple of days, with minimal discomfort.1 HIFU patients
also experience fewer side effects than those receiving traditional prostate treatments.2 During the first two weeks after the procedure, patients may experience mild urinary symptoms, such as frequency and/or urgency to void. In the first three months, patients may also pass an occasional small amount of blood or mucus-like materials, which is normal.
HIFU is radiation-free. Unlike radiation, ultrasound energy is non-ionizing, meaning that it will not harm any tissue outside of the targeted area. (Damaged tissue could set the stage for a possible cancer recurrence.) Because HIFU is performed without an incision, patients don’t experience blood loss and can usually be discharged after recovery from the general or epidural anesthesia. Furthermore, because HIFU uses ultrasound rather than radiation to destroy targeted tissue, the procedure can be repeated if necessary.
During the HIFU procedure, all or part of the prostate is ablated, including the prostatic urethra. The urethra is derived from a different type of tissue (bladder squamous-type epithelium) than the prostate (glandular, fibrotic and muscular) and does restore itself with time. A suprapubic or penile catheter is inserted for one to three weeks until prostate swelling resolves.
The machine used to transmit HIFU uses a computer-controlled device designed for transrectal delivery of energy to the prostate. It features a fully integrated probe
with dual treatment transducers that move robotically to follow the physician’s precise treatment plan.
Urologists around the globe, as well as those in U.S. involved in clinical trials, have been using HIFU to treat localized prostate cancer and recurrent prostate cancer/radiation failure with both focal therapy and whole-gland therapy. Worldwide, over 7,000 HIFU prostate treatments have been performed to date.
Accurate imaging is a key component. The technology makes use of integrated biplanar ultrasound imaging for real-time treatment monitoring, treatment planning, and pre- and post-treatment imaging of the prostate. Precise focusing of ultrasound energy during HIFU treatment rapidly elevates the temperature of the tissue to 90 degrees Celsius in the focal zone, while intervening tissue between the transducer and the focal zone is kept
at a safe temperature.
The result of HIFU therapy is an accurate and repeatable lesion at the target sites that are monitored in real time by the treating physician. All treatment zones are pre-planned and checked by the physician prior to HIFU treatment. The procedure allows for a customizable treatment plan tailored to each patient’s prostate cancer diagnosis. The imaging capabilities of the technology also allows for the identification of vital structures, such as the prostate capsule, seminal vesicles, rectal wall, and the physiological location of neurovascular bundles.
A radio frequency (RF) signal is sent to a treatment site prior to delivery of HIFU, and then another signal is sent after delivery to the same site. A sophisticated tissue-change monitoring system calculates the change that took place and displays it on the screen by
quantifying tissue changes based on a comparison of RF ultrasound pulseecho signals at each treatment site. This tracking procedure shows results using real-time ultrasound imaging aided by advanced tissue-change monitoring software.
An integrated Doppler feature in the transrectal probe provides an additional safeguard during treatment. This feature helps physicians identify vital structures that need to be preserved to avoid problems with urinary continence and sexual function. With HIFU’s
precisely targeted accuracy, there is less damage to the surrounding area, such as the muscle controlling urine flow and the nerves controlling erections.
HIFU technology remains investigational in the United States, but it is being studied for the treatment of prostate cancer in U.S. clinical trials. The technology has been approved in more than 30 other countries in Europe, South America and North America (Canada and Mexico). The Food & Drug Administration has scheduled a panel review of HIFU technology for early October that may result in a decision within 60 days.
When Dr. Michael Lazar makes weekend trips to Puerto Vallarta, Mexico, it’s for business — to use a high-tech device to treat men with prostate cancer.
Lazar, a Santa Rosa urologist for 30 years, is the only Northern California physician regularly treating patients with high-intensity focused ultrasound, known as HIFU, which is currently not approved for use in the United States.
But HIFU, used for a decade or more in other countries, is “hands-down,” Lazar said, the best treatment for prostate cancer, the most non-skin common cancer in men and second only to lung cancer in deaths.
HIFU is the only non-invasive and radiation-free treatment for the disease, which was diagnosed in nearly 240,000 American men last year and caused almost 30,000 deaths, Lazar said.
The process uses an “acoustic scalpel” of high-intensity sound waves focused to a tiny point and heated to 200 degrees Fahrenheit, literally burning away cancerous growth and leaving all other tissues untouched.
Lazar, who’s performed about 100 HIFU procedures since 2007, said the success rate — in terms of keeping patients cancer-free — is comparable to the conventional treatments: surgery, radiation or cryotherapy.
The payoff, he said, is that HIFU is “substantially less likely” to result in impotence or incontinence, the major risks of the other treatments.
Radiation, in addition, is a prolonged, tiring treatment that also risks cancer due to chromosome mutation and internal burns.
HIFU procedures are relatively quick, and patients, following recovery from anesthesia, experience little pain or bleeding because the ultrasound waves seal off nerves and blood vessels, Lazar said.
“You’re on your feet, you can go out and eat” the evening after surgery, he said.
Temple Smith of Cloverdale had a HIFU procedure done by Lazar more than five years ago and said he remains cancer-free. Smith’s uncle died of prostate cancer and his brother, who had surgery to remove his prostate, became incontinent.
“If you have prostate cancer and the resources to get the HIFU treatment, get it done,” Smith said.
Another patient, Harlow Plimpton of San Francisco, had the treatment in 2011 and experienced no side-effects.
“Since then I’ve been looking for a downside, but frankly I haven’t found any,” Plimpton said.
Cost is the rub, Lazar said.
HIFU costs $25,000 and may or may not be covered by insurance. “It’s a leap of faith,” Lazar said, explaining that patients pay for the procedure and take the chance it will be covered.
Many of his patients obtain a home equity loan to pay for the treatment, he said.
HIFU has been performed for years in Japan, Europe and Canada, and is approved for use in more than 30 countries. Closest to home, it is available in Puerto Vallarta and Cancun in Mexico, as well as Nassau, Bermuda, Toronto and Montreal.
Hospital San Javier in Puerto Vallarta, where Lazar works seven or eight weekends year, is accredited by the Joint Commission, which accredits U.S. hospitals.
In the U.S., HIFU is pending approval by the Food and Drug Administration, which has accepted the results of a clinical trial involving 100 American patients whose prostate cancer returned following radiation treatment.
HIFU had a 70 percent success rate in the trial, said Lazar, who was a proctor during the trial.
Dr. Stephen Scionti, a urologist and prostate cancer expert in Framingham, Mass., said that HIFU, under the right conditions, “offers the best opportunity for excellent results” in treating prostate cancer.
HIFU also has potential for treating cancers of the kidney, uterus, bladder and liver, Scionti said. It has the potential to treat breast cancer, Lazar said.
The FDA’s decision on HIFU is expected within year. Approval in the U.S. is a prolonged, expensive process, and the agency will not accept results from other countries, Lazar said.
by Michael J. Lazar, MD
Prostate cancer is the leading form of solid organ cancer in the U.S. and the fourth most common form of cancer in the world. According to the U.S. National Institutes of Health, the U.S. had more than 27,000 deaths in 2009 due to prostate cancer, which usually strikes older men. Those who have been diagnosed with prostate cancer and have explored treatment options have been faced with some difficult choices. Which treatment is likely to be most effective? Which has the fewest associated risks? What are the side effects?
Traditional treatments include: radiation therapy, surgery, freezing the cancerous gland, hormonal therapy and chemotherapy. Physicians base treatment recommendations on many factors such as tumor size, spread of the disease and the patient’s medical status and history. Fortunately advances in research and technology have produced another non-invasive option with relatively few side effects: High Intensity Focused Ultrasound, or HIFU. As with other treatment options, urologists carefully screen patients before recommending this option to make sure they are an appropriate candidate for HIFU.
HIFU treatment is advanced medical technology that uses ultrasound to rapidly and precisely apply heat at a level that is lethal to prostate tissue. It destroys the entire prostate gland or focuses only on the cancerous portion of it. This highly localized treatment leaves the surrounding tissue unharmed.
With this quick, non-surgical outpatient procedure, patients usually have a spinal anesthesia. Because the procedure is performed without an incision, patients do not experience blood loss, typically regain normal mobility within only a few hours of treatment with minimal discomfort usually treatable without pain killers, and can return to normal activity within a few days. With HIFU, the negative side-effects of traditional treatments are greatly diminished. Since there is less damage to the surrounding area, such as the muscle controlling urine flow and the nerves controlling erections, negative side effects are minimized, and patients can return to a normal lifestyle.
The oncological results of HIFU are broadly comparable to radical prostatectomy, but the patient benefits outweigh those of other treatment options. In addition, HIFU is the only non-invasive prostate cancer therapy that uses clean (or non-ionizing) energy, allowing patients to repeat treatments if necessary without collateral tissue damage.
With Sonablate® 500 technology, developed by Focus Surgery, Inc. of Indianapolis, Indiana, the doctor is able to obtain real-time ultrasound images of the prostate and surrounding areas. From these images, the surgeon determines precisely where the High Intensity Focused Ultrasound energy will be delivered. The technology then allows the surgeon to visually direct the treatment and destroy the targeted gland or selected portions. This is the only non-radiation technology that requires no direct contact with the target organ.
HIFU technology has been extensively studied and has advanced to point that it effectively represents the next generation of prostate cancer treatment. No other form of treatment allows the surgeon the control to so precisely pinpoint the targeted area and effectively ablate it without damaging the surrounding tissue.
Reported in AUA Daily Scope, from The Telegraph (British magazine): Combination chemotherapy and immune therapy resulted in enhanced immune system activation against widespread human prostate cancer that had been implanted in mice. The metastatic disease was “wiped out”.
This is exciting, but it remains to be seen whether similar results will be seen in humans. Over the years, many promising animal model therapies have not translated into useful treatments in people. For all our similarities to animals, we are much more complex, and their corresponding immune systems may be stronger than ours through natural selection over time.