Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00005075
- Lead Sponsor
- EDAP Technomed
- Brief Summary
RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body temperature. This treatment may be effective for prostate cancer.
PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating patients who have stage I or stage II prostate cancer that has recurred following radiation therapy.
- Detailed Description
OBJECTIVES: I. Determine the effectiveness of the Ablatherm high-intensity focused ultrasound device in providing control of disease for at least 12 months after treatment in patients with stage I or II prostate cancer recurring after external beam radiotherapy. II. Determine the safety of this treatment device in these patients.
OUTLINE: This is an open-label, multicenter study. A probe is inserted into the rectum. Ultrasound energy is then delivered through probe to prostate tissue over 2-3 hours. Quality of life is assessed at study initiation; at 14 days and 3, 6, and 12 months; and then annually thereafter. Patients are followed at 14 days; at 3, 6, 9, and 12 months; and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States