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Hal & Mary: Another Happy HIFU Story

Posted on HIFU Prostate Services 5/27/2017

If you ask Hal Plimpton, he will tell you that he is a semi-retired, international logistics consultant who has owned and operated his own business for many years.

If his wife, Mary, happens to hear him say he is “semi” retired, she will laugh and probably roll her eyes. “He was supposed to retire 15 years ago, but he’s still working,” said Mary.

However, one thing that Hal and Mary can agree on is that they made a good treatment decision several years ago when Hal was diagnosed with prostate cancer.

“I could tell that he felt really good about HIFU (high intensity focused ultrasound). He had confidence in the technology that it was going to work. I was a little nervous about all the unknowns, but ultimately I knew that if he felt good about it he would have a good experience – so I felt good about it too, “ said Mary.

Hal may have ultimately been confident in HIFU, but it wasn’t a conclusion he came to without doing a lot of research first – and connecting with a lot of people.

Mary and Hal’s prostate cancer journey included ups and downs that finally led them to the right decision for Hal but their experience with diagnosis and research on treatments was extensive – and in some respects, disconcerting.

“I followed my PSA for many years with my family doctor but in February of 2011, he referred me to a urologist for a biopsy,” said Hal. The pathology report indicated that he had prostate cancer with a Gleason score of 7.

“The first urologist we saw outlined several traditional treatments including surgery and radiation; I felt really uncomfortable with what I heard about the potential side effects,” said Hal.

“We were given some brochures and told to read them and decide what we wanted to do,” Mary said. “At that point, we went into research mode

“We saw a handful of doctors and it was not pleasant, informative or reassuring,” said Mary. “The physicians were focused on conventional treatment options, and we felt like each of them was trying to sell us on a specific treatment that they were personally invested in. It was very disheartening.”

“We found one book that had a single page about HIFU. Hal is kind of an ‘early adopter,’ and he was intrigued. But a urologist we spoke with was dismissive.” Mary said.

Coincidentally, Mary and Hal talked to a neighbor who connected them to a friend who had had a successful HIFU procedure some 5 years previously in Canada. Hal was able to talk to him at length and felt a heightened interest in the technique.

Mary was also learning more about HIFU. Curious about this new-to-them technology which she knew was of interest to Hal. She Googled the topic, picked up the phone, and called a company called, USHIFU in North Carolina. She was connected to a nurse, Karen, who was teamed with Dr. Michael Lazar, the then-sole HIFU-trained urologist in northern California.

Karen was wonderful. Our conversation was educational, but more than that she was a sympathetic ear,” said Mary. “She sent me a packet of information and before long we had an appointment to see Dr. Lazar.”

Meeting with Dr. Lazar was very different than their experiences with the other doctors they had seen. “He was so open and empathetic. He answered all our questions and was just very informative,” said Hal.

“He was was not selling any one particular approach. It was a very different kind of appointment from others we’d had,” added Mary.

Hal had HIFU with Dr. Lazar in Puerto Vallarta, Mexico in June of 2011 (HIFU wasn’t available in the U.S. outside of a clinical trial until after October 2015). A couple of friends accompanied them to PV for moral support – and one ended up having HIFU himself a few months later, also with Dr. Lazar.

“I might have opted for something more conventional but I knew this is what HAL WANTED, and, to me, I felt that if he believed in it, that elevated the likelihood of a positive outcome,” said Mary. “I cannot imagine that we could have had a better experience – in all respects – and it worked for us.”

Hal is happy to report that after HIFU, his PSA dropped from 7 to 0.1 and has stayed stable ever since. Almost more importantly, he had no adverse side effects.

“We are believers in HIFU for sure,” said Hal. “HIFU may not be ‘the answer’ for every man, but for families researching their options, we would urge you to consider HIFU. – And we cannot say enough good things about Dr. Lazar.”

By | May 31st, 2017|Dr. Michael Lazar, HIFU, News, Prostate Cancer|0 Comments

Doctor’s Own Prostate Cancer Diagnosis Leads to Early Intervention and Positive Results with HIFU

Dr. Michael Lazar of California HIFU shares the story of how friend and fellow surgeon Dr. Robert Pugach underwent HIFU treatment for prostate cancer following an early diagnosis with the disease.

Dr. Robert Pugach

It’s the news no man wants to hear from a doctor, “… you have prostate cancer.” And when you are a practicing physician who receives this news, all the more room for concern. Dr. Robert Pugach, medical director of Pacific Coast Urology Medical Center was diagnosed with prostate cancer last year and opted to undergo HIFU treatment with urologist and prostate cancer specialist Dr. Michael Lazar of California HIFU earlier this month. What transpired is truly an inspirational account of one man’s journey from diagnosis to cure. Dr. Pugach has chronicled his experience in a series of blog posts featured on the HIFU Prostate Services Website.

Following a cancer diagnosis by an internist and a follow-up biopsy with Dr. Lazar, Dr. Pugach opted to forgo the wait and watch approach most commonly prescribed for men testing with low levels of PSA. “I’m not a gambler, especially when it comes to my health,” he says. “I plan to live a long, healthy life.”

As a prostate cancer expert himself, Dr. Puach was all too aware of the potential for permanent urinary incontinence and erectile dysfunction with more conventional treatments, and was adamant about avoiding radiation due to the likelihood of a cancer recurrence in the future. Bolstered by his own experience with HIFU combined with positive results viewed first-hand with his own brother who underwent HIFU almost a decade earlier, Dr. Pauch was in the perfect frame of mind for pursing HIFU for himself.

In the weeks leading up to the procedure with Dr. Lazar and California HIFU, Dr. Pauch reasoned that there was absolutely nothing to fear, having been diagnosed early and having confidence in his doctor gave him a sense of empowerment over the disease.

“I had complete and total confidence in my doctor. I had the luxury of knowing Dr. Lazar well for 10 years when we travelled out of the country with our patients to treat their cancers with HIFU. When you watch someone in the OR, a fellow doctor like me can tell instantly what his skill level is. In Michael Lazar’s case, he is as good as one can get and is a true professional,” he explains.

HIFU: Non-invasive Treatment for Prostate Cancer

HIFU is a FDA approved precise and targeted therapy for the treatment of prostate cancer, that reduces the risk of complications caused by surgery and radiation. HIFU uses ultrasound energy, or sound waves, to heat and destroy specifically targeted areas of tissue. During HIFU, the sound waves pass through healthy tissue without causing damage. At the focal point of the sound waves (like a magnifying glass focusing the rays of the sun to burn a leaf), the tissue temperature is raised only high enough to destroy the targeted tissue.

“Although recommendations are that most men opt to wait and watch when diagnosed with prostate cancer, HIFU is a treatment that is most effective for men who have early stage, localized prostate cancer that has not spread or metastasized outside the prostate,” explains Dr. Lazar. “As with Dr. Pugach the results are most promising when the cancer is caught while it is at the early, more treatable stage. That means; taking action relatively soon following the diagnosis.”

A happy ending to a terrifying diagnosis

On May 9th Dr. Pugach took a taxi to the San Francisco Surgery Center where Dr. Lazar performs HIFU. There the new patient was greeted by “… a wonderful and caring staff.” A short four hours later, the procedure is over and Dr. Lazar reported to the patient that all is well. “Dr. Lazar told me my procedure went perfectly – good words to hear!”

As most HIFU patients report, Dr. Pugach says there was no pain following the procedure and recovery was swift. “I learned that what I had always told my patients about how good they would feel afterwards was now proven to me to be true. Instead of having the common side effects of radical surgery, or contemplating seven weeks of radiation, I felt great…”

Dr. Pugach says he knows how good it feels to have a potentially serious or lethal disease diagnosed at a stage where it is less frightening to deal with. “I’ve learned how wonderful and enduring a good doctor-patient relationship can be and how a good bedside manner does more than many medications in helping a patient feel good.”

The moral of this story may well be to consider all of the options when dealing with prostate cancer, and although the temptation might be to put off routine screenings, early diagnosis might just save your life.

“Screening for prostate cancer is a simple process that allows us to look for cancer before any symptoms become obvious to the patient,” explains Dr. Lazar. “This process can help us discover the cancer at an earlier stage while the patient has the opportunity to take advantage of newer, less invasive options for treating prostate cancer such as HIFU.”

About California HIFU and Dr. Lazar

Dr. Michael Lazar is the only Northern California physician recognized as a leader in the use HIFU for prostate cancer. He has been successfully treating patients with HIFU since 2007. Dr. Lazar formed California HIFU in order to offer minimally invasive prostate cancer treatment to men with the Sonablate. For more information about HIFU treatment or to make an appointment call: (707) 546-5553 or visit our website: www.californiahifu.com.

Dr. Pugach’s full story “When the Doctor Becomes the Patient” may be viewed online in an ongoing series on the HIFU Prostate Services Website.

 

New blood test better at predicting prostate cancer risk than PSA

A new blood test known as IsoPSA detects prostate cancer more precisely than current tests in two crucial measures — distinguishing cancer from benign conditions, and identifying patients with high-risk disease. By identifying molecular changes in the PSA protein, the findings of this study suggest that once validated, use of IsoPSA may reduce the need for biopsy, and may lower the likelihood of overdetection and overtreatment of nonlethal prostate cancer.

A team of researchers from Cleveland Clinic, Louis Stokes Cleveland VA Medical Center, Kaiser Permanente Northwest, and other clinical sites have demonstrated that a new blood test known as IsoPSA detects prostate cancer more precisely than current tests in two crucial measures — distinguishing cancer from benign conditions, and identifying patients with high-risk disease.

By identifying molecular changes in the prostate specific antigen (PSA) protein, the findings, published online last month by European Urology, suggest that once validated, use of IsoPSA may substantially reduce the need for biopsy, and may thus lower the likelihood of overdetection and overtreatment of nonlethal prostate cancer.

The research team, led by Cleveland Clinic’s Eric Klein, M.D., conducted a multi center prospective study of 261 men scheduled for prostate biopsy at five academic and community centers in the U.S. enrolled between August 2015 and December 2016.

“Despite criticism, PSA has transformed the landscape of early detection, screening, and management of prostate cancer in the last few decades,” said Dr. Klein, chair of Cleveland Clinic’s Glickman Urological & Kidney Institute. “Unfortunately, PSA is tissue-specific but not cancer-specific, leading to overdiagnosis and overtreatment of biologically insignificant cancers, which is widely recognized as a key limitation in its clinical utility.”

The study directly compared the clinical performance of a new test based on PSA, called IsoPSA, to PSA itself with patients already scheduled for prostate biopsy. IsoPSA proved significantly superior to PSA in two key indications: discriminating between prostate cancer and benign conditions; and identifying patients with high-grade disease. The former indication is potentially useful for using IsoPSA for screening by primary care physicians, while the second is helpful for urologists in identifying patients who would benefit from curative intent therapy and other applications.

The results show that if validated and adopted clinically, IsoPSA could significantly reduce the rate of unnecessary biopsies by almost 50 percent. “The methodology used in the IsoPSA assay represents a significant departure from conventional ways to define biomarkers in blood, and may be applicable to improving other cancer biomarkers,” said Dr. Klein.

“Due to its inherent simplicity, requiring only a blood draw and presenting information to the physician in familiar context using a single number — just like PSA itself — we are quite hopeful in IsoPSA’s future utility after further validation studies,” said Mark Stovsky, M.D., co-author and staff member, Cleveland Clinic Glickman Urological & Kidney Institute.


Story Source: Materials provided by Cleveland Clinic.

Journal Reference: Eric A. Klein, Arnon Chait, Jason M. Hafron, Kenneth M. Kernen, Kannan Manickam, Andrew J. Stephenson, Mathew Wagner, Hui Zhu, Aimee Kestranek, Boris Zaslavsky, Mark Stovsky. The Single-parameter, Structure-based IsoPSA Assay Demonstrates Improved Diagnostic Accuracy for Detection of Any Prostate Cancer and High-grade Prostate Cancer Compared to a Concentration-based Assay of Total Prostate-specific Antigen: A Preliminary Repo. European Urology, 2017; DOI: 10.1016/j.eururo.2017.03.025

Read this article on Science Daily. “New blood test is more accurate in predicting prostate cancer risk than PSA: IsoPSA assay can help in determining the need for prostate biopsy for patients.” ScienceDaily. ScienceDaily, 15 May 2017. www.sciencedaily.com/releases/2017/05/170515122149.htm.

By | May 16th, 2017|Dr. Michael Lazar, HIFU, News, Prostate Cancer|0 Comments

Santa Rosa Urologist Dr. Michael Lazar is Making History with a Nonsurgical, Outpatient Treatment for Prostate Cancer

Dr. Lazar and his staff are proud to be early leaders in the usage of HIFU.

Dr. Lazar and his staff are proud to be early leaders in the usage of HIFU.

High-intensity focused ultrasound (HIFU) waves target cancer cells with precision in a one-to-four-hour procedure that has little or no side affects and a quick recovery rate, giving those diagnosed with prostate cancer another choice over surgery or radiation.

HIFU has been used in other countries for years, and Dr. Lazar has been instrumental in bringing this innovative treatment to the United States. It was approved by the Food and Drug Administration last October, and he has since been performing the procedure at San Francisco Surgery Center for patients who travel from across the country to receive this leading edge treatment.

“The oncological results for HIFU are broadly comparable to radical surgery or radiation but the side effects are less,” says Dr. Lazar. “If the HIFU 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.”

Dr. Lazar has recently become involved with HIFU Prostate Services, LLC as their Medical Director.  HIFU Prostate Services is the first company to establish centers in the United States offering Sonablate HIFU technology. HIFU Prostate Services makes the non-invasive treatment option available through partnerships with some of the largest urology practices and experienced physicians that establish Sonablate HIFU Centers of Excellence.  Urologists are able to create their own HIFU program and offer treatment within their region. These centers also offer training and proctorship opportunities.

Along with serving as the Medical Director of HIFU Prostate Services, LLC. Dr. Lazar is also a clinical partner with his HIFU Center of Excellence at the state-of-the-art SFSC in downtown San Francisco. Dr. Lazar and his staff are proud to be early leaders in the usage of HIFU. He has worked tirelessly with SonaCare, the manufacturer of the instruments, to bring this innovative service for prostate cancer treatment to patients in the United States.

The HIFU technique is also being developed to treat many other types of cancer including breast, uterine, liver, kidney, and brain.

For those with prostate cancer, HIFU treatment is most effective for patients with early stage cancer, where it is localized to the prostate. It is performed on an out-patient basis that takes one to four hours. A urinary catheter is placed after the procedure for one to three weeks.

While some patients might experience slight irritation, “some patients can have a catheter and they don’t even know it.”

The procedure preserves healthy tissue and nerves, so urine flow and erectile function is maintained in a high percent of cases, as compared to radical surgery or radiation.

Another advantage is recovery time. With surgery or radiation treatment, recuperation time for patients is six to eight weeks, whereas HIFU patients return to normal activities within days.

Dr-michael-lazarDr. Lazar has been treating U.S. prostate cancer patients in Mexico since 2007, where he performed hundreds of outpatient procedures at a U.S. Joint Commission approved bilingual hospital. There, he also served as a HIFU instructor for other physicians and is now training doctors in San Francisco.

Because the treatment is so new, it will take another couple of years before it will be routinely covered by insurance. Those with non-Medicare insurance may get reimbursed to varying degrees.

“What will really make this explode is when the insurance companies are routinely covering the procedure and it will become widely available to all patients. The costs for this procedure are drastically less than for radical surgical and radiation procedures, and with fewer complications so insurance companies will be incentivized to cover it,” Dr. Lazar commented.

As soon as more doctors are trained to perform the procedure in San Francisco, Dr. Lazar plans to bring the treatment to his Santa Rosa office.

“I expect as word gets out there will be a progressive demand for this procedure, so training physicians will be a high priority. It’s already expanding rapidly and we put in an order for our tenth machine,” said Dr. Lazar, adding he won’t be giving up his general urology practice any time soon. “This is what I love to do.”

 

 

 

First Prostate Cancer Patient Treated with Minimally Invasive HIFU on West Coast

Dr. Michael Lazar performing first HIFU surgery on the West Coast at San Francisco Surgery Center

Dr. Michael Lazar performing first HIFU surgery on the West Coast at San Francisco Surgery Center

November 18, 2015. San Francisco, CA – HIFU Prostate Services, LLC, a leading provider of minimally- invasive prostate cancer treatment, using High Intensity Focused Ultrasound (HIFU), announced that physician partner and Medical Director, Michael J. Lazar, MD treated the first prostate cancer patient in California with minimally invasive HIFU on November 18, in San Francisco at the San Francisco Surgery Center (SFSC). This will be the second patient ever treated in the country using Sonablate HIFU technology.

HIFU Prostate Services has partnered with Lazar and SFSC to establish a HIFU Center of Excellence where patients can receive the recently FDA-cleared Sonablate HIFU treatment. SFSC is located in downtown San Francisco, near Union Square, which offers patients a state-of-the-art facility in downtown that is convenient to hotels and the airport for men who will be traveling from around the country for this non-invasive treatment.

Lazar, who also serves as Medical Director of HIFU Prostate Services, has been working with HIFU since 2007, and was one of three physicians who proctored cases during clinical trials. Lazar will offer HIFU treatment to qualified patients and also provide medical guidance and serve as a proctor to physicians that are being trained on the Sonablate® HIFU system in San Francisco and surgery centers around the country.

Kevin Wienke, Administrator of the San Francisco Surgery Center states, “The Center is proud to be able to receive one of the first Sonablate® HIFU Systems in the country and to partner with Dr. Lazar and HIFU Prostate Services to offer our patients a viable option for prostate cancer.”

John W. Linn, chief executive officer of HIFU Prostate Services said, “The Sonablate® is the first device to receive regulatory authorization from the FDA for the ablation of prostate tissue. HIFU has been available in other countries for more than 10 years, but we are proud to be the first to make this game-changing technology available in the United States”.

Since 2004, approximately 4,000 U.S. men have been treated outside the U.S. where this technology is approved in over 30 countries. HIFU offers an effective treatment for localized prostate cancer with significantly less risk of common side effects, such as impotence and incontinence, which are typically reported with surgery and radiation.

Ken Hicks, a patient of Dr. Lazar’s who received HIFU treatment in 2007 in Puerto Vallarta, Mexico says, “Finally men in the U.S. can receive this innovative, minimally invasive therapy for their prostate cancers without traveling internationally. I still can’t believe I was eating dinner on the beach just hours after my HIFU procedure and I am doing great after 7 years. I highly recommend Dr. Lazar and HIFU to anyone who is eligible for this incredible procedure.”

About Dr. Michael Lazar

Lazar HIFU

A great medical partnership begins in San Francisco. Kevin Wienke (L), Administrator SF-SC and Dr. Michael Lazar (R), Director of HIFU Prostate Services.

Dr. Lazar is currently the Medical Director of HIFU Prostate Services (HPS) and clinical partner with HPS and SFSC with the HIFU program. He has been certified by the American Board of Urology four times and has practiced in Santa Rosa, Calif. since 1983. He is chairman of the Board of Redwood Health Services, Inc. providing insurance products for employee groups. Lazar is also CEO and managing director of Santa Rosa Surgical Management Company, LLC that manages the ambulatory surgery center at Santa Rosa Memorial Hospital. Lazar received his urology training at Louisiana State University in New Orleans, La. and is a graduate of University of Arkansas Medical School.

For more information on Dr. Lazar, visit www.californiahifu.com

About HIFU Prostate Services, LLC

HIFU Prostate Services (HPS) was founded in 2015 to provide men access to a less invasive treatment option for prostate disease focused on preserving quality of life. The mission of HPS is to partner with physicians to deliver the highest quality of care, support and technology to the patient and to the urology community for the treatment of localized prostate cancer using high intensity focused ultrasound (HIFU). HPS is lead by a seasoned management team with over 50 years of experience in the healthcare industry and over 30 years focused on HIFU technologies The company is headquartered in Charlotte, NC.

For additional information, visit www.hifuprostateservices.com.

By | November 18th, 2015|Dr. Michael Lazar, HIFU, News|0 Comments

High Intensity Focused Ultrasound (HIFU) Therapy is Gaining International Acceptance for the Treatment of Medical Conditions

your-questions-answeredA growing number of international medical organizations have already adopted High Intensity Focused Ultrasound (HIFU) therapy for treating an increasing number of conditions, and as a viable option to traditional invasive surgery, according to Dr. Michael Lazar, a Santa Rosa, California-based Urologist and a leading advocate for HIFU as an effective treatment for prostate cancer.

Dr. Lazar states, “The scientific community has known for years that high heat kills cancer. But only in recent years has the science advanced to the point where focused ultrasound energy can be used to provide pinpoint accuracy, sparing healthy tissue and preserving nerves, urine flow and erectile function in a majority of cases compared with traditional procedures, while also delivering the required amount of heat needed to destroy, or ablate, cancer.”

Today HIFU is being deployed around the world, especially in Europe, for the treatment of abdominal kidney tumors, urological cancers, uterine fibroids, and to relieve neuropathic pain associated with bone cancer, in addition to being a non-invasive treatment for prostate cancer. Medical literature also reports the use of HIFU in treating liver, breast and brain tumors as well as other conditions.”

For example, according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) located in Vienna, Austria, positive results were achieved with transcranial Magnetic Resonance MR-guided focused ultrasound surgery (tcMRgFUS) as a non-invasive treatment of essential tremors, neuropathic pain and Parkinson’s disease. CIRSE also reports that there have also been some investigations into the use of HIFU for temporarily opening the blood-brain barrier, allowing absorption of drugs into the brain.

Furthermore, a minimally invasive catheter-based HIFU system — designed to ablate heart tissue responsible for atrial fibrillation — has been approved for use in Europe and is undergoing an FDA approved trial in the United States.

“Adoption of HIFU has proceeded at a faster rate among international medical communities than in the United States, however, there are hopeful signs that this technique will soon be available to a broader range of patients here at home so they will not have to travel to hospitals outside of the U.S. to take advantage of this procedure,” Dr. Lazar said.

For more information about Dr. Michael Lazar, go to the HIFU website or call (707) 546-5553. His office is located at 1140 Sonoma Ave #1A, in Santa Rosa, CA 95405.

Indianapolis, Indiana-based SonaCare Medical LLC, a leading developer of minimally-invasive HIFU technology, is bringing several HIFU systems to market to meet growing global demand. SonaCare Medical, LLC, serves customers around the world through its family of affiliate companies including: USHIFU, International HIFU and Focus Surgery. For additional information, go to: www.sonacaremedical.com.

Patient Testimonial: “I cannot be more appreciative of his comprehensive approach to treating patients ….” – Charles Lawrence

Click to View PDFAs a retired malpractice insurance professional, Charles Lawrence is very familiar with the many complex problems in today’s healthcare industry. He knows what to look for in a good doctor, and he deeply appreciates quality healthcare services. When Charles thought he was having urinary problems, he came to see Dr. Michael J. Lazar in Santa Rosa for an examination. Dr. Lazar didn’t find any problems with Charles’ urinary system, and Charles’ symptoms went away on their own shortly thereafter. However, Dr. Lazar discovered a lump on his thyroid that other physicians had failed to find previously …

Lazar testimonial 8.18 lower half

 

By | August 18th, 2015|Dr. Michael Lazar, Testimonials|0 Comments

International HIFU Physician Dr. Michael Lazar

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 nurse@internationalhifu.com.

HIgh Intensity Focused Ultrasound

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.

By | May 7th, 2015|Alternative Treatment for Prostate Cancer, Dr. Michael Lazar, HIFU, Prostate Cancer, Uncategorized|Comments Off on HIgh Intensity Focused Ultrasound

Santa Rosa doctor journeys outside U.S. to practice new prostate cancer treatment

Dr-michael-lazar
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.