High Intensity Focused Ultrasound for Locally Recurrent Prostate Cancer Following External Beam Radiation Therapy Investigated in Phase III Clinical Study



    CHARLOTTE, N.C., Sept. 11 /CNW/ -- In a new study, men with locally
recurrent prostate cancer may be able to receive a promising investigational
ultrasound treatment option.
    A Phase III clinical trial at Specialists in Urology, located in North
Naples, FL, is investigating the safety and efficacy of High Intensity Focused
Ultrasound (HIFU) for the treatment of locally recurrent prostate cancer
following failed external beam radiation therapy (EBRT). HIFU is a minimally
invasive procedure that uses ultrasound energy to destroy cancerous tissue
with focused sound waves.
    The lead investigator of this trial site is Dr. Nicholas Franco. This is
one of several trial sites in the nation approved by the Food and Drug
Administration to participate in the trial, which will begin enrolling
patients in September.
    HIFU is intended to eliminate cancer by elevating tissue temperatures to
more than 195 degrees Fahrenheit in a matter of seconds. The Sonablate(R) 500,
the therapeutic ultrasound device, which will be used in the study, is
designed to destroy the entire gland in one procedure without causing damage
to tissue around the prostate.
    Eligible participants for the trial must be between the ages of 40 and
80, have biopsy confirmed local recurrence two or more years following EBRT,
confined prostate cancer with a prostate specific antigen (PSA) greater than
or equal to .5 ng/mL and less than or equal to 10 ng/mL and a Gleason score of
less than or equal to seven.
    For more information about enrolling in the HIFU trial, call
1-877-874-4389, or visit www.ProstateCancerRecurrentTrial.org.
    This investigational treatment is performed on an outpatient basis.
Potential risks of the treatment include frequency, urgency, mild discomfort
or discharge in urinary stream. Less common side effects may also include
urinary stricture, retention, incontinence, impotence and rectal fistula.
    Prostate cancer is the most common type of non-skin cancer in American
men and the second leading cause of cancer deaths in men. The American Cancer
Society estimates that there were about 234,460 new cases of prostate cancer
in the U.S. in 2006 and that 27,350 men die annually from the disease.




For further information:

For further information: Amanda Willis of USHIFU, +1-704-936-1823,
amandawillis@ushifu.com Web Site: http://www.ProstateCancerRecurrentTrial.org

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