Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- Remaining volume of HA
研究概览
简要总结
The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically verified prostatic cancer
- •Low or intermediate risk prostatic cancer
- •Lymph node negative
- •Suitable for radiotherapy
排除标准
- •Earlier treatment for prostatic cancer
- •Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment
研究组 & 干预措施
Hyaluronic acid
Hyaluronic acid will be injected in the space between the prostate and rectum prior to radiotherapy to perform a dorsal movement of rectum.
干预措施: Hyaluronic acid (Device)
结局指标
主要结局
Remaining volume of HA
时间窗: 24 month after end of radiotherapy
Measurement on the remaining volume of HA by MRI
次要结局
- Quality of life(24 month after end of radiotherapy)
研究者
Anders Widmark
Professor, MD
Umeå University