Executives of EDAP and SonaCare Medical – two focused ultrasound device makers that are engaged in commercialization activities – say healthcare trends are creating a unique opportunity for their companies and for men with localized prostate cancer.
During the past 20 years, cancer treatments have evolved from emphasizing whole organ removal – such as performing a prostatectomy for prostate cancer – to treating and controlling the primary disease while leaving the affected organ intact.
The second trend involves oncologic surgery. “In former times, surgeons cut out cancer, and that was the way cancer was handled,” says Mark Schoenberg, MD, chief medical officer for SonaCare and professor of urology at Johns Hopkins University School of Medicine. Today, surgeons have embraced the use of ablative therapies – a category that includes focused ultrasound – to treat tumors.
“We can now develop strategies for imaging and destroying tumors without necessarily making incisions in patients,” Schoenberg says.
The third trend is the dramatic shift in in the profile of the average prostate cancer patient due to increased preventive screenings and early detection. “Twenty years ago, patients were typically diagnosed in their late 60s or early 70s and had a life expectancy after diagnosis of about seven to eight years,” says Marc Oczachowski, chief executive officer of EDAP. The goal was radical treatment efficacy without considering the patient’s ongoing quality of life.
“Today, patients are diagnosed in their late 50s and have a life expectancy of 80. Because patients will live with a diagnosis of prostate cancer for about 20 to 25 years, the strategy of treatment has completely changed,” he observes. “Nowadays, patients and urologists are looking for some alternatives that will be able to control the disease and preserve quality of life.”
Effective treatment that preserves quality of life
For some urologists, the best option has been to switch from one extreme to another. Instead of radical treatment of early stage, localized prostate cancer, they now recommend active surveillance, or watchful waiting. “But, that’s not satisfactory for the patient who has been diagnosed with prostate cancer,” notes Oczachowski. “There is a need for a non-invasive alternative that will give a certain control over the disease with a high preservation of quality of life.”
He adds, “By using HIFU, you can really determine where you’re going to treat and where you’re going to deliver the high intensity focused ultrasound so you can really preserve erectile nerves or preserve the sphincters, so that you avoid the most common complications of prostate cancer treatment which is incontinence and impotence.”
Mark Carol, MD, chief development officer for SonaCare, asserts that focused ultrasound treatments performed under ultrasound guidance are also a cost-effective option for clinicians and their patients. “We believe that the technology offers the opportunity to bring these kinds of focal treatments to a much wider range of patients and physicians simply because it’s less expensive than MRI-based options. It’s smaller. It uses ultrasound to image and treat at the same time. It enables some procedures to be done in doctors’ offices or in ambulatory surgery centers,” he says.
Summing up, Schoenberg notes, “This type of technology represents, I believe, the frontier of where surgical oncology is going to move in the future. So, it’s tremendously exciting for clinicians.”
Commercialization moving to U.S. market
EDAP was the first to market a focused ultrasound treatment for localized prostate cancer. Its Ablatherm HIFU device received CE marking for that indication in 2000 and has been cleared for distribution in the European Union, South Korea, Canada, Australia, South Africa, New Zealand, the Philippines, Taiwan, Mexico, Argentina, Brazil and Russia. The system has successfully performed more than 32,000 prostate cancer procedures, and treatment results have been published in 60 peer-reviewed scientific publications. EDAP is now pursuing regulatory approval in the U.S. and China. Recently filed, its Premarket Approval (PMA) application is under review at the U.S. Food and Drug Administration.
SonaCare, which was formerly known as US HIFU, is commercializing its Sonablate 500 Transrectal Prostate HIFU Probe. The device received CE marking in 2001 and has been approved for use in more than 30 countries for the treatment of primary and focal prostate cancer. To date, the system has treated more than 12,000 patients, including Americans who have sought care at offshore facilities staffed by U.S. physicians. In its soon-to-be-submitted PMA application, the company will seek clearance to market its Sonablate 450 system in the U.S. to perform salvage therapy for recurrent localized prostate cancer.
Written by Ellen C., McKenna