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Monthly Archives: May 2017

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

Focused ultrasound therapy is here: Are you ready?

A new, highly disruptive therapeutic technology called focused ultrasound is transforming – standards of care around the globe.

In this series, we asked speakers at the Milken Institute Global Conference to answer: How does one build a meaningful life in the age of technological disruption? Join the conversation by writing your own article here and including #MIGlobal.

A new, highly disruptive therapeutic technology called focused ultrasound is slowly but definitively influencing – and on the verge of transforming – standards of care around the globe. This game-changing, noninvasive treatment option for a wide variety of serious medical disorders has the potential to be an alternative or adjunct to surgery, radiation therapy, drug delivery, and cancer immunotherapy, while decreasing cost of care and improving outcomes for millions worldwide. If it sounds too good to be true, it isn’t. Focused ultrasound has been named one of the 50 greatest inventions by TIME magazine, credited with “changing medicine” by Fortune magazine, and just this month was named a top 10 clinical research achievement of 2016 by the Washington, DC-based Clinical Research Forum.

Innovation breeds innovation, but also, modification. Once fully developed and implemented – months to decades from now depending on the clinical indication – focused ultrasound will have widespread impact on healthcare constituents including physicians, treatment facilities, and manufacturers of legacy therapy equipment, among others. This process has in fact already begun. Focused ultrasound will also bring about major change to referral patterns, treatment paradigms, practice guidelines, and equipment acquisition as the technology transitions to a mainstream therapy.

In order to benefit from these changes, stakeholders – perhaps your organization or yourself – must be prepared to enter the field early on. And for many, “early on” means now.

What is focused ultrasound?

Focused ultrasound, or FUS, uses ultrasonic energy to target tissue deep in the body without incisions or radiation. With more than 22 regulatory approvals around the world to date, including five by the US Food and Drug Administration and more than 50 additional clinical indications in various (mostly early) stages of development, FUS may treat a disparate range of diseases including: Parkinson’s; Alzheimer’s; depression; obsessive-compulsive disorder; arthritis; back pain; and, tumors of the brain, breast, prostate, liver and pancreas. It has the potential to be as revolutionary to therapy as magnetic resonance scanning (MRI) has been to diagnosis.

The basic principle is analogous to using a magnifying glass to focus beams of sunlight on a single point to burn a hole in a leaf. With focused ultrasound, multiple intersecting beams of ultrasound energy are concentrated on a target deep in the body with extreme precision and accuracy (sparing adjacent normal tissue). Where each individual beam passes through the body there is no effect. But at the focal point where the beams converge, the focused ultrasound energy induces a variety of biologic effects including: destroying tissue, stimulating the body’s immune response, and enhancing the delivery of drugs. The location of the focal point and the treatment effect is guided and controlled in real time by ultrasound or MR imaging.

Besides patients, who will focused ultrasound affect?

Three healthcare industry groups will be particularly impacted by the widespread adoption of FUS. First, consider the manufacturers of legacy therapy equipment (e.g., linear accelerators for radiation therapy and robotic surgical devices) to which focused ultrasound is an existential threat. These manufacturers would be wise to begin redistributing resources from their traditional product lines now to invest in new FUS technology. Such companies are in fact well-positioned to do so as they already have the functioning sales, marketing, support and distribution channels in place. It is clear that once the medical community broadly understands the capabilities of focused ultrasound, many legacy therapy equipment options will quickly become obsolete.

Physicians will also benefit from entering the FUS field sooner rather than later. In the current environment, many physicians – not all – can unfortunately be motivated by money, time and outcome, in that order. As focused ultrasound advances, they will need to become educated and trained in utilizing FUS technology, and adopt it as part of their practice, even in cases where the economics on a per procedure basis are less favorable than current therapy alternatives. If they choose not to, patients seeking FUS – and demand is growing – will simply find a physician who will. Of note: focused ultrasound centers worldwide are reporting a backlog of several hundred essential tremor patients desiring FUS, and a nationwide study of nearly 1,000 US uterine fibroid sufferers (published in the October 2013 issues of both the American Journal of Obstetrics and Gynecology and the Journal of Women’s Health) found that when presented with fibroid treatment descriptions, the majority surveyed (60%) rated focused ultrasound as their top treatment choice.

Finally, now is also the time for hospitals and clinics to consider becoming early adopters of focused ultrasound. Doing so will enhance their reputation as being on the leading edge of medical care, and will provide a competitive differential over institutions that have not yet acquired FUS technology (see above regarding patient demand and preference). Additionally, offering focused ultrasound will create a halo effect for the hospital or clinic when patients are referred for this cutting-edge treatment and found to not be a candidate; these patients will often choose to stay with the practice and receive an alternative treatment, increasing market share for the institution.

The future is now

We are all aware that medical device development and adoption occurs exponentially; with focused ultrasound we are right now at the beginning of the inflection point of the curve. Our goal is to treat hundreds of thousands of patients annually and we are well on our way, with 15,000 FUS treatments performed worldwide in 2014, approximately 25,000 treatments in 2015, and a more than double increase to 50,000-plus patients treated in 2016. In other words, focused ultrasound is about to evolve into a robust medical field, with the pace of research and development, publications, patient treatments and the number of device manufacturers all increasing rapidly in the past few years.

Still, there remains an enormous amount of work to be done, and many barriers to overcome, before the technology becomes a standard of care that can help millions of patients. But we are closer than ever. When the potential of focused ultrasound is realized and it becomes a mainstream therapy, it will result in changes that will benefit countless patients and impact physicians, payers/providers, manufacturers, hospitals/clinics, caretakers, etc., around the globe. It’s coming. It is reinventing care. Are you ready?

Find out more at www.fusfoundation.org

About the Author: Neal F. Kassell, M.D., is the founder and chairman of the Focused Ultrasound Foundation. He was a Professor of Neurosurgery at the University of Virginia from 1984 until 2016 and was the Co-Chairman of the department until 2006. He received both his undergraduate and medical education at the University of Pennsylvania. In April 2016, Dr. Kassell was appointed by Vice President Joe Biden to the National Cancer Institute’s Blue Ribbon Panel for Cancer Moonshot Initiative. Dr. Kassell has contributed more than 500 publications and book chapters to the literature and is a member of numerous medical societies in the United States and abroad.

The Focused Ultrasound Foundation is a medical research, education, and advocacy organization created as the catalyst to accelerate the development and adoption of FUS, shortening the time from laboratory research to widespread patient treatment. 

By | May 4th, 2017|HIFU, News, Prostate Cancer|0 Comments