US HIFU to fund investigation of focal therapy for prostate cancer
9 March 2010
US HIFU has announced its intention to fund a landmark
multi-center trial to study focal therapy for localized prostate cancer.
Mark Emberton, consultant urological surgeon and divisional clinical
director of cancer services at University College London Hospital
(UCLH), along with Hashim Uddin Ahmed, MRC clinical research fellow,
will lead the trial.
The primary objectives of the trial are to evaluate quality of
life outcomes and safety of focal therapy in the treatment of
localized prostate cancer. A secondary objective is to measure the
costs of treatment and model the cost-effectiveness of focal therapy
using US HIFU's proprietary Sonablate 500 technology. The study will
involve four centers initially and may expand to as many as 10
centres in the UK.
"I believe that focal treatment is the future for early-stage,
low-risk cancer. Considering the treatments that are currently
approved and available worldwide, men with localized prostate cancer
may often feel they must choose between active surveillance and
radical therapy (surgery or radiation)," said Emberton.
"Patients who opt to monitor their cancer run the risk of having
the disease spread, while those who choose radical therapy are at
increased risk for incontinence and impotence. I see focal therapy
as a cost-effective solution that can potentially provide an optimal
balance between cancer control and co-morbidity issues."
Naren Sanghvi, US HIFU's chief scientific officer, said, "The
management of prostate cancer is entering a time of dramatic change.
While surgery and radiation therapy will continue to play important
roles in the treatment of some patients, new approaches designed to
serve those with minimal, focal or slow-growing cancer, for example,
deserve scholarly attention and merit evaluation in bona fide
"The Emberton Study, supported by US HIFU, attempts to address
issues central to an emerging new paradigm in cancer management
which could be termed 'therapeutic surveillance.' The goal of
therapeutic surveillance would be focal, possibly repetitive, cancer
ablation with minimal morbidity facilitated by serial non-invasive
The ability to accurately and precisely detect cancerous lesions
as well as ongoing disease monitoring, and management if necessary,
are keys to effective focal therapy and paramount to trial
"Over the past year, US HIFU has been working with thought
leaders around the world to come up with what we believe is the most
well thought-out and defensible trial design to initially evaluate
HIFU-induced focal therapy while compensating as thoroughly as
possible for the flaws associated with biopsy diagnosis," said Steve
Puckett, Jr., US HIFU's chief executive officer.
"We look forward to discussing the specifics of our trial design
with top academic investigators from around the world at the
upcoming focal conference in Washington."
Sonablate HIFU for prostate cancer is a minimally invasive,
targeted approach to treating disease with precision-focused
ultrasound energy that, when delivered, raises the temperature of
the tissue in a matter of seconds. The extreme, rapid-firing heat
destroys the tissue at a specific target, known as a lesion, which
measures 12x3x3 mm, approximately the size of a grain of rice.
Lesions are created throughout the prostate that result in its