This report highlights focused ultrasound (FUS or HIFU, high-intensity focused ultrasound) to treat the prostate. Two HIFU systems earned FDA approval in 2015, providing men with prostate diseases, such as BPH and prostate cancer, a new option.
Two Focused Ultrasound Systems Now Approved for Treating the Prostate in the US
Men in America will no longer have to travel out of the country to receive focused ultrasound (HIFU) treatment for their prostate. In October 2015 the Food and Drug Administration (FDA) approved – for the first time in the United States – a focused ultrasound system, SonaCare Medical’s Sonablate 450, for the ablation of prostate tissue. Three weeks later, the FDA approved EDAP’s Ablatherm Robotic HIFU for the ablation of prostate tissue. The US now joins approximately 50 countries around the world where HIFU is commercially available for treating the prostate.
"For men with conditions like prostate cancer, the option of a non-invasive procedure that can selectively target and treat diseased tissue is very appealing." – Neal Kassell, MD, Focused Ultrasound Foundation chairman
“This is a milestone for non-invasive prostate care and a tremendous gain for men’s health,” said Mark Carol, MD, CEO of SonaCare Medical. “There are numerous peer-reviewed articles attesting to focused ultrasound’s value in ablating the prostate while minimizing the occurrence of side effects.”
Marc Oczachowski, EDAP's CEO stated, “The pieces are in place for rapid deployment of Ablatherm devices in the US, and we look forward to bringing the technology to urologists as well as patients in need.”
Prostate ablation is the leading application of focused ultrasound, having been used to treat benign prostatic hyperplasia (BPH), partial gland cancer, localized whole-gland cancer, and recurrent cancer. While HIFU may be helpful, active surveillance may be the most appropriate approach for early disease. In cases where the physician recommends treatment or the patient prefers treatment, focused ultrasound may be a good alternative.
Focused ultrasound can be considered a non-invasive therapy as the actual treatment does not involve any direct cutting of the skin and there is no physical “removal” of prostate tissue. The probe for delivering the treatment is inserted into the rectum on current FDA approved systems, and it does not utilize ionizing radiation. READ MORE >
Several Prostate Systems on the Market and In Development
There are many companies involved in the development of HIFU systems to treat the prostate. The chart below shows the latest on prostate treatment approaches and research from EDAP, HistoSonics, Insightec, Profound Medical, and SonaCare.
L to R: Drs. Robertson, Suarez, Ward
"I feel focused ultrasound will have the greatest impact on men with minimal disease seeking treatment that want to avoid the side-effects of radical treatments and find the decades of repeat prostate biopsy and guessing associated with active surveillance equally unpalatable." – Dr. Ward
HIFU Experts Discuss Focused Ultrasound for Prostate
We spoke with three experts – Dr. Cary Robertson, Dr. George Suarez, and Dr. John Ward – to get their take on the recent FDA approvals, their experience with the technology, and predictions for the future.
Dr. Robertson is a urologic oncologist and Associate Professor, Division of Urology, Department of Surgery, Duke University Medical Center. He was national Principal Investigator for the clinical trial assessing the safety and effectiveness of EDAP’s Ablatherm as the initial treatment in men with newly diagnosed localized prostate cancer, compared to cryotherapy. READ MORE FROM DR. ROBERTSON >
Known as one of the world’s leading experts in the technology, Dr. Suarez has performed over 2,000 HIFU procedures and has trained more than 400 doctors. Dr. Suarez is a practicing urologist in Miami, and a former faculty member of the University of Miami department of Urology. He is Co-Founder and former Medical Director of SonaCare Medical. READ MORE FROM DR. SUAREZ >
Dr. Ward is Associate Professor of Surgery, Department of Urology, at the University of Texas M.D. Anderson Cancer Center. His center participated in all EDAP and SonaCare-sponsored FDA registration trials. He is interested in focal therapy for prostate cancer. READ MORE FROM DR. WARD >
We spoke with Mark Carol and Marc Oczachowski – the CEOs of SonaCare and EDAP– whose devices received FDA approval to ablate prostate tissue. Learn more about their company visions, devices, strategies for the US market, and their thoughts on the future of the field.
Q. What is your vision for your organization? A.For SonaCare to be a global leader in developing and providing therapeutic ultrasound technology to physicians so that they can improve the quality, reduce the cost, and advance the outcomes for the treatment of a wide range of clinical disorders.–Carol READ MORE FROM MARK CAROL >
A.The clearance of HIFU for prostate ablation by the FDA has given our technology world-class recognition and acceptance. The vision for EDAP is to further expand and penetrate the prostate market worldwide and to continue our investment in innovation in non-invasive therapies based on therapeutic ultrasound. –Oczachowski READ MORE FROM MARC OCZACHOWSKI >
HPS is the first company to establish centers in the US offering SonaCare’s Sonablate HIFU technology.
HIFU Prostate Services Partners with Physicians for Success
In the wake of FDA approval, HIFU Prostate Services (HPS) has been created to facilitate rapid adoption of focused ultrasound treatment for the prostate. We interviewed John Linn, CEO of HPS, to better understand the company’s plans for successful commercialization of FUS technology in the US, patient support and recruitment, and physician support and training.
"I hope that someone reads this story and realizes that there’s a lot of reason to be very hopeful." – Reed Yadon
Sunny Forecast for Meteorologist Treated with Focused Ultrasound for Prostate Cancer
Reed Yadon was living a busy life as a television meteorologist and helicopter pilot when his world suddenly changed. After a routine annual physical revealed his prostate-specific antigen (PSA) level had increased, a urologist confirmed one of his worst fears: he had prostate cancer.
Luckily, Reed’s cancer was Stage 1, so he had many options for treatment. He spent the next four days researching treatment options online, including focused ultrasound, which was first mentioned to him by his family physician. His urologist confirmed that Reed was a candidate for HIFU.
While the FDA approvals of Sonablate and Ablatherm have been met with enthusiasm by many HIFU thought leaders and patients, some experts caution that questions still remain about the treatment as it relates to prostate disease. Read more about some of the challenges and questions being asked by the community – including: concerns about the data, the importance of physician skill in performing the procedure, and active surveillance versus HIFU treatment in low-risk patients – in Cancer Therapy Advisor, Medscape (Study Oversells HIFU Benefits), and Urology Times.
Information on where or how to find HIFU centers across the US can be found below.
Research on focused ultrasound and prostate disease continues around the world; to date there have been more than 80 studies involving thousands of patients assessing the benefits of FUS and the treatment of prostate diseases. Below are some selected papers that discuss the treatment of prostate cancer and/or BPH with HIFU: