A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT
研究概览
简要总结
The goal of this study is to identify any side effects caused by the implanting of markers via the rectum. The investigators will also try to determine if any other factors (such as the position of the markers) influence the risk of side effects. The study procedures consist of two questionnaires:The first will be completed immediately after the marker implantation and the second questionnaire will be completed during your radiotherapy planning.
详细描述
Precise localisation of target organs has become increasingly important with the routine use of steep dose gradients from conformal and intensity modulated radiotherapy. This is particularly challenging when soft tissue target organs, such as the prostate, displace relative to bony anatomy. Although novel imaging techniques are being developed for the direct visualisation of such soft tissue structures, contrast and image quality is currently limited. However, the use of radio-opaque intra-prostatic fiducial markers(IPM) during high dose radiotherapy has proven very effective in terms of improving accuracy, and decreasing toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have biopsy confirmed prostate cancer (any risk category)
- •Have 3 intra-prostatic markers inserted at PMH prior to radiotherapy
- •Be willing to provide written informed consent
- •Be willing to complete the adverse event questionnaires
排除标准
- 未提供
结局指标
主要结局
Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT
时间窗: 1.5 years
次要结局
未报告次要终点