Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Proportion of study participants that complete the study
研究概览
简要总结
The aim of the present feasibility study of a new short palliative radiotherapy regime that apply to patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominating debilitating symptom. Diffusion weighted magnetic resonance imaging (DWI) will apply to identify both the lesion and the most aggressive part of the lesion. The symptomatic lesions will be treated with a dose of 4 x 5 Gy, while for the most aggressive part of the lesion the dose will be escalated to 4 x 7 Gy using a simultaneous integrated boost (SIB) technique.
详细描述
Please refer to uploaded Study Protocol
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
- •Patients with hormone refractory biopsy proven prostate cancer
- •Presenting with a dominating debilitating symptom
- •Expected median survival of 12 months
- •Focal irradiation of lesion is feasible
- •Systemic therapy according to guidelines
- •age ≥18 years
- •Legal capacity, able to understand consequences of the trial
- •Written informed consent
排除标准
- •Relevant comorbidity (limiting radiotherapy according to protocol)
- •Prior radiotherapy limitations to administer radiotherapy according to protocol
- •No large metal implants in vicinity of lesion
- •Department dose constraints for normal tissue can't be met
- •Large bony lesions with extensive osseous destruction
- •Patients symptoms do not correlate with MR findings
研究组 & 干预措施
feasibilty
Palliative Radiotherapy
干预措施: Palliative radiotherapy (Radiation)
结局指标
主要结局
Proportion of study participants that complete the study
时间窗: 6 months
Proportion of study participants that complete radiotherapy with ≥ 90% of prescribed dose
次要结局
- Response in dominating symptom score (short form McGill pain Questionnaire)(Baseline, 1,3 and 6 months after radiotherapy)
- Acute radiation toxicity score using CTCAE(Baseline, 1,3 and 6 months after radiotherapy)
- Quality of life score using EORTC QLQ-C30(Baseline and 6 months after radiotherapy)