Findings appear in this month's Journal of Urology
CHARLOTTE, NC, April 28 /CNW/ - USHIFU LLC (US HIFU), a world leader in
minimally invasive high intensity focused ultrasound (HIFU)
technologies and manufacturer of the Sonablate® 500 (Sonablate) medical
device, announces results from the first-ever prospective clinical
investigation of HIFU with the Sonablate (Sonablate HIFU) to focally
treat prostate cancer, a modality in which only the confirmed cancerous
regions within the gland are treated as opposed to the entire prostate.
Results from the study appear in this month's Journal of Urology.
Researchers at UCL (University College London) and clinicians at
University College London Hospitals NHS Foundation Trust (UCLH), backed
by US HIFU and eight U.K. partner organizations* conducted the
ethics-approved, independently audited study to determine the
effectiveness of focal Sonablate HIFU at reducing side effects such as
impotence and incontinence--comorbidities that can accompany more
traditional modes of treatment and diminish a patient's quality of
life--while also treating the cancer.
Trial investigators treated 20 patients with low- and medium-risk
disease by delivering HIFU energy to the side of the prostate affected
by cancer, a procedure known as a hemi-ablation. Patients returned
regularly for follow-up testing for one year following treatment. Study
results showed reduced harmful side effects and positive cancer control
"Based on percentages, our early trial results have shown that more men
were unaffected by the long-term problems of leaking urine or poor
sexual function than has been possible with any other standard
treatments," said Professor Mark Emberton, M.D., chief study
investigator and clinical director for cancer services at UCLH. "Early
cancer control was also very encouraging, but more work needs to be
done to look at this," said Emberton.
"Nearly 90 percent of study participants achieved the perfect result, or
trifecta status, meaning that they achieved pad-free, leak-free
continence, erections sufficient for intercourse and cancer control at
12 months. In addition, 95 percent of participants achieved good
erections, 90 percent had no cancer on tissue samples taken following
treatment and 100 percent had no significant cancer.
"Prostate cancer has a long natural history, meaning that the cancer
grows slowly. Focal therapy appears to offer the balance between
treating the cancer and minimizing the collateral tissue damage, which
marks a paradigm shift in how we treat prostate cancer," said Hashim
Uddin Ahmed, lead author and clinical lecturer in urology at UCL.
Sonablate HIFU is a minimally invasive, targeted approach to treating
prostate cancer with precision-focused ultrasound energy that, when
delivered, raises the temperature of the tissue in a matter of seconds,
resulting in its destruction. The targeted tissue is ablated while
untargeted tissue remains unharmed.
Study authors concluded that the results were sufficiently promising to
support the further evaluation of focal therapy. A larger, multi-center
study involving more than 120 patients across the U.K. will determine
whether the findings are reproducible. "Currently the decision pathways
for how to manage prostate cancer are very polarized. On one end of the
spectrum you can do nothing and monitor the disease and, on the other
end, there is radical intervention which is associated with major
quality-of-life implications," said US HIFU CEO Steve Puckett, Jr. "We
believe focal HIFU will strike the right balancing act between these
Sonablate HIFU is under FDA investigation in the U.S., but commercially
available in more than 30 countries. There are nearly 400 trained
Sonablate users worldwide. More than 9,000 patients have undergone
Sonablate HIFU outside the U.S. where the technology is available.
*A complete list of U.K. partner organizations may be found at www.pelicancancer.org.
About USHIFU LLC
USHIFU LLC (US HIFU), a privately held healthcare company, is a world
leader in minimally invasive high intensity focused ultrasound (HIFU)
technologies. US HIFU is committed to treating prostate cancer using
HIFU with the Sonablate® 500, a minimally invasive, outpatient
procedure pioneered to control cancer and significantly improve
patients' quality of life. The company is engaged in ongoing research
for technological advancements for the Sonablate® system and/or other
US HIFU was founded in 2004 and is headquartered in Charlotte, N.C.
Additional information may be found at www.ushifu.com.
About the Sonablate® 500
Focus Surgery, Inc., a US HIFU subsidiary based in Indianapolis, Ind.,
developed the Sonablate® 500 medical device. Takai Hospital Supply Ltd.
distributes the Sonablate® 500 in Southeast Asia. The Sonablate® 500 is
approved for investigational use within the U.S. and is being studied
for the treatment of prostate cancer in clinical trials in the U.S. The
FDA has made no decision as to the safety or efficacy of the Sonablate®
500 for the treatment of prostate cancer. Currently, the device is
available for the treatment of prostate cancer outside the U.S. in more
than 30 countries.
SOURCE USHIFU LLC
For further information:
Blake Marler, Director of Corporate Communications, +1-704-936-1824, email@example.com /Web Site: http://www.ushifu.com