Enrollment in UCLA Clinical Trial Now Open
UCLA urologists have opened enrollment for the West Coast site of a national study using high-intensity focused ultrasound (HIFU) to treat prostate cancer, recurrent following X-ray therapy.
The investigational non-invasive HIFU treatment is being offered at UCLA on an out-patient basis. There is no placebo arm in the study and all study-related costs are borne by the sponsor USHIFU (http://www.ushifu.com/).
"Many patients who receive radiation (X-ray) therapy for prostate cancer suffer recurrent disease," said Dr. Leonard Marks, principal investigator and professor of urology, David Geffen School of Medicine at UCLA. "This new treatment may offer an effective non-invasive option to eradicate recurrent cancer."
HIFU is an exacting technique aiming sound waves at the prostate tissue, rapidly increasing tissue temperature, which destroys the cancerous lesions. To qualify for the clinical trial, participants must have recurrent prostate cancer after treatment with external beam radiation therapy. Initial screening visits will involve physical exams, blood tests and an ultrasound of the prostate.
Qualifying participants will receive the outpatient HIFU procedure under anesthesia and follow-up for a year after treatment. All study-related costs, including the HIFU treatment, will be covered by the research study.
Common procedural side effects include temporary pain in the area where the HIFU was performed, inability or difficulty with urination, and blood in the urine or semen.
The study is sponsored by Focus Surgery, Inc., manufacturer of The Sonablate® 500 system, which is the HIFU technology used in the study. Several thousand HIFU procedures have been performed in other countries, but the treatment is currently considered investigational in the United States. The study is part of an FDA-approved clinical trial, which is also approved by the UCLA institutional review board and registered at http://www.clinicaltrials.gov.
For more information about the study, please call Malu Macairan, research coordinator, at 310-794-3566.
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