NCT05656794招募中2 期
Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rates of acute toxicity
研究概览
简要总结
This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically-proven prostate cancer
- •Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)
- •Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)
- •Planned for EBRT
- •ECOG 0 or 1
- •Age 18 years or older
排除标准
- •Prior radiotherapy to pelvis
- •Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
- •Any condition where radiotherapy is contraindicated
结局指标
主要结局
Rates of acute toxicity
时间窗: 5 years
Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0
次要结局
- Measure failure-free survival(5 years)
- Rates of late toxicity.(5 years)
- Quality of Life Outcomes(5 years)
研究者
研究点 (1)
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