A Feasibility Study of Post-operative Adaptive Radiation Therapy for Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in radiation dose delivered to target volumes and normal tissue
研究概览
简要总结
This study will ultimately aim to evaluate the side effects of treatment by asking 20 subjects to receive post-operative radiotherapy for prostate cancer with the treatment plan adapted after the first week of treatment to account for changes in the target shape. These patients will be asked to complete toxicity scores and a quality of life questionnaire at the start and completion of treatment, and at 3 months 1, 2 and 5 years from the start of radiotherapy. These results will be used to determine the feasibility of the proposed approach, and obtain early estimates of improvements in uncertainty margin requirements for this population of patients.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy AND
- •Clinical stage pT3, pT4, or pT2 with positive margin OR
- •Any p-Stage with a persistently elevated post-operative PSA > 0.05 ng/ml OR
- •A delayed rise in PSA post-operatively
排除标准
- •Inflammatory bowel disease or other contraindications to radiotherapy
- •Prior pelvic radiotherapy
- •Previous cytotoxic chemotherapy
- •Radiological or pathologic evidence of nodal metastases.
- •Planned radiotherapy to pelvic lymph nodes
- •Evidence of systemic metastases on imaging.
- •Prosthetic hip replacement
- •No signed informed consent
研究组 & 干预措施
Post-Operative adaptive radiotherapy
All Patients enrolled in this study will have additional scans (Cone-Beam CT, MRI) daily during their treatment. This extra imaging will help us see any changes that might have occurred during radiation treatment and update the treatment plan to include these changes before patient treatment is continued.
干预措施: Post-operative Adaptive Radiation Therapy (Radiation)
结局指标
主要结局
Change in radiation dose delivered to target volumes and normal tissue
时间窗: 5 years
次要结局
- Time for radiotherapy replanning(5 years)
- Toxicity associated with the adaptive radiotherapy technique.(5 years)
- Volumetric modulated arc therapy impact in a clinical adaptive Radiotherapy workflow.(5 years)