Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 12
- 主要终点
- Metastases progression-free survival (MPFS)
研究概览
简要总结
The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiotherapy without hormonal therapy
Metastase-directed radiotherapy without the addition of hormonal therapy
干预措施: Radiotherapy (Radiation)
Radiotherapy combined with hormonal therapy
Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)
干预措施: Radiotherapy (Radiation)
Radiotherapy combined with hormonal therapy
Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)
干预措施: Leuprorelin (Drug)
结局指标
主要结局
Metastases progression-free survival (MPFS)
时间窗: 2.5 years after treatment
The primary aim of this project is to test the hypothesis that the addition of ADT to MDRT in well-selected PCa patients with oligo-metastatic disease (OM) prolongs the metastases progression-free survival (MPFS) compared to MDRT alone
次要结局
未报告次要终点