Protection of Rectum From High Radiation Doses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Spacer Volume Half Life
研究概览
简要总结
The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy.
详细描述
Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low dose brachytherapy will be recruited. Diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, 4 weeks after the operation and 8 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 8 to 16 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 76 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer
排除标准
- •not willing to participate this study
研究组 & 干预措施
Spacer
Subjects with spacer injection
干预措施: DuraSeal (Device)
结局指标
主要结局
Spacer Volume Half Life
时间窗: 1 day, 4 weeks, 8 weeks, up-to 16 weeks
Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.
次要结局
- Side Effects(1 day, 4 weeks, 8 weeks, 12 weeks)
- Rectum Radiation Dose(1 day, 4 weeks, 8 weeks)
研究者
Markku Vaarala, MD, PhD
MD, PhD
University of Oulu
