The purpose of this study is to evaluate the Ablatherm
treatment system for the control of localized prostate cancer in
patients who have experienced a local recurrence of their cancer
after previous external beam radiation therapy. The study will involve
approximately 120 patients in 3-4 medical centers, and the findings
will be presented to the Food and Drug Administration (FDA).
Patient Participation : We invite your and/or your
physicians' inquiries about our study. It is important that all
patient must meet the following criteria in order to be considered
for inclusion in this study.
The primary requirements are:
Diagnosed with organ-confined prostate
cancer, where the disease has recurred following radiation treatment;
At least 50 years of age and in
good general health PSA, Gleason score and clinical stage sufficient
to warrant local therapy (i.e., using Kattan nomogram, score
greater than 0.5);
Radiation treatment was completed
at least 18 months ago;
No use of hormonal therapy within
the last 6 months. You should discuss these in detail with your
doctor.
If you feel your condition is consistent with the
criteria and you or your doctor would like further information,
please contact one of the treatment centers listed below.
How the Therapy Works?
The Ablatherm works by using
the ultrasound image to define the shape of the prostate gland and
to map the treatment regions. The device then uses high-intensity
focused ultrasound (HIFU) technology to heat the targeted areas
to therapeutic temperatures.
A coolant is circulated around the treatment probe to ensure a proper
energy delivery and to maintain a safe rectal wall temperature.
Study/ Treatment Locations*
Hospital / Urologist
Georgetown University Medical Center
Dr. John Lynch
Washington, DC
Lombardi Cancer Center
Lombardi CancerLine
Tel: 202 784-4000
Baylor University Medical Center
Dr. Brian Miles
Houston, TX http://www.urol.bcm.tmc.edu/
Study Coordinator
Tel: 713 798-8514
University of California at San Francisco
Dr. Peter Carroll
Dr. Katsuto Shinohara
San Francisco, CA
UCSF Website
Investigator's Office
Tel: 415 353-2200
*NOTE: When calling the above sites, please indicate
that you are inquiring about the HIFU prostate cancer study