Evaluation of the Ablatherm High Intensity Focused Ultrasound Device After Failed Radiation Therapy for Localized Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 试验地点
- 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供