Welcome to our special update, "Men's health and MR-guided focused ultrasound."
Its focus: the tremendous progress being made by researchers, clinicians and device makers who are developing new treatments for two conditions that afflict millions of men worldwide – prostate cancer and benign prostatic hyperplasia (BPH).
Prostate cancer ranks among the most commonly diagnosed cancers in men. The World Health Organization expected 900,000 new prostate cancer cases to be diagnosed globally in 2010, and the American Cancer Society estimated that 217,730 would be in the U.S. As you might expect, expenditures for prostate cancer are staggering. The G7 countries (U.S., U.K., France, Italy, Germany, Spain and Japan) spend an estimated $15 billion each year coping with this disease.
Thanks to advances in early detection, most prostate cancers are diagnosed and treated at an early stage. Five-year survival rates have reached an amazing 99 percent. Today's greatest treatment challenge is avoiding common and debilitating side effects like impotency and incontinence. With their superior precision, new MR-guided ultrasound therapies could significantly reduce or eliminate these side effects and offer other patient advantages.
BPH is another major health concern among men. An age-related disorder, BPH restricts urinary flow and causes significant bladder problems. Medications and minimally-invasive treatments are available. However, the most definitive treatment for BPH is surgery. In fact, BPH surgeries outnumber those for prostate cancer in the U.S. by 3:1. Promising early-stage research suggests that MR-guided focused ultrasound could bring BPH treatments and patient benefits to a new level.
The most exciting news for prostate cancer patients is that two investigational MR-guided sonication devices are being evaluated in clinical trials:
Sunnybrook Health Sciences Centre in Toronto has completed the first clinical trial of its new transurethral device and is planning several more in-house patientstudies.
In coming months, Profound Medical, Inc. will launch U.S. clinical trials of a transurethral device based on technology licensed from Sunnybrook.
InSightec is enrolling patients in a multi-center clinical trial of its new ExAblate Prostate System, which uses a transrectal applicator to deliver treatments.
Preclinical research also looks promising:
Collaborators at Stanford University and the University of California San Francisco have developed a transurethral MR-guided focused ultrasound device that could revolutionize the treatment of BPH.
Foundation-funded research at Fox Chase Cancer Center has shown that pulsed MR-guided focused ultrasound enhances the delivery of chemotherapy to prostate tumors.
Scroll below to learn more about these important developments.
Pre-eminent physician-entrepreneur, Frederic H. Moll, elected to board of Focused Ultrasound Surgery Foundation
The FUS Foundation Board of Directors has elected a new member, Frederic H. Moll, M.D., a serial entrepreneur whose start-up ventures have included Intuitive Surgical, Inc., manufacturer of one of today's most successful and innovative medical devices, the da Vinci Surgical System.
"I'm delighted to join the board of an organization that is devoted to advancing a noninvasive, game-changing technology like MR-guided focused ultrasound,"Moll said. “It could change the paradigm for treating many serious disorders and improve millions of lives worldwide.”
Applauding the Foundation's mission, he said, "My work has focused on evolving surgical techniques through new technologies. The Foundation is championing a technology that could totally revolutionize minimally-invasive surgery, radiation therapy and drug delivery."
A study in successful medical device entrepreneurship, Dr. Moll's career has spanned nearly three decades.
Laurence Klotz, M.D., a urologic oncologist at the University of Toronto's Sunnybrook Health Sciences Centre, says planning is underway for a second clinical trial using an investigational transurethral ultrasound device developed at Sunnybrook to ablate prostate cancer.
The new study will build on the results of a 2009-2010 clinical trial that assessed the device's ability to deliver ultrasound energy to a targeted area within the prostate. Klotz explains. "We found that the correlation is very tight. All the tissue that was destroyed was within about a millimeter of our target."
In the first study, eight patients were treated with the device and then had a radical prostatectomy.
Patients participating in the new study will have their cancer targeted by the device and then undergo a prostatectomy. Post-surgical assessment will determine if the device effectively destroyed their cancer.
As many as 30 patients with early stage prostate cancer could be treated with a new, minimally-invasive device in a clinical trial expected to begin at two U.S. hospitals later this year, says Paul Chipperton, CEO of Profound Medical, Inc. (PMI).
The trial will evaluate the safety and effectiveness of the company's innovative MR-guided thermal ultrasound device, which Chipperton says has the potential to treat patients three to six times faster with greater accuracy and fewer side effects than existing options.
InSightec reports that two new sites have joined its Phase 1 clinical trial assessing the ExAblate Prostate System and 14 patients with low-risk prostate cancer have now received treatment.
The newly added sites are the University of Rome in La Sapienza, Italy and Jaslok Hospital in Mumbai, India. The other participating sites are the N.N. Petrov Research Institute of Oncology in Saint Petersburg, Russia and the National Cancer Centre at the Singapore General Hospital in Singapore.
Graham Sommer, M.D., professor of radiology at Stanford University Medical Center, is opening up a new frontier in men's health for MR-guided focused ultrasound treatments. He and his colleagues at Stanford and the University of California, San Francisco have developed a device that uses this innovative, noninvasive technology to treat benign prostatic hyperplasia, or BPH.
Study shows MR-guided FUS enhances chemotherapy delivery to prostate tumors
FUSF-funded researcher update: Lili Chen, Ph.D., Fox Chase Cancer Center, USA
While others explore the ablative potential of MR-guided focused ultrasound to treat early-stage prostate cancer, Lili Chen, Ph.D., has been assessing the technology's ability to enhance chemotherapy delivery to more advanced prostate tumors. Her recent study, which was supported by a Research Award from the FUS Foundation, was published in the November 2010 issue of Physics in Medicine and Biology.
Chen, an associate professor and medical physicist in the Radiation Oncology Department of Fox Chase Cancer Center in Philadelphia, used her Foundation funding to determine if:
high intensity focused ultrasound would increase the cellular uptake of the chemotherapy drug, docetaxel, in prostate tumors in mice;
increased docetaxel uptake combined with radiotherapy would enhance tumor growth inhibition
Docetaxal, which is routinely used to treat advanced hormone refractory prostate cancer, has been found to improve survival in prostate cancer patients. Chen found significantly higher concentrations of docetaxel in prostate tumors when mice received pulsed MR-guided focused ultrasound.
She says further study is needed to investigate the effect of focused ultrasound on tumor growth control.
Chen's study co-authors were Zhaomei Mu, Paul Hachem, C-M Ma, Annie Wallentine and Alan Pollack.
Click here to read FUS Foundation newsletter report. Click here to read Physics in Medicine and Biology article.