DAHLIA: Docetaxel with Abiraterone full versus low dose in Hormone SensitiveAdvanced Prostate Cancer – Phase III, Non-Inferiority Randomized Control OpenLabel Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- To compare the non inferiority of low dose abiraterone 250mg with low fat meal compared to hogh dose abiraterone 1000mg with in fasting state to improve 3 year PSA PFS in patients with hormone sensitive metastatic prostate cancer receiving Androgen deprivation therapy+docetaxel chemotherapy
研究概览
简要总结
Prostate cancer is the second most common malignancy worldwide. Abiraterone and Docetaxel are used in the metastatic prostate cancer to increase the overall survival. Both drugs have different mechanism and have ability to show more outcome in Hormone Sensitive Prostate Cancer when combined together. It is important to understand rationale use of drug since high dose may significant side effects. Thereby, we would like to compare low dose abiraterone with low fat meal versus full dose abiraterone when given in combination with docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •participants must be hormone sensitive prostrate cancer.
- •Age above 18 years ECOG permance status <2 participants must have normal organ and marrow function.
排除标准
- •1.participants who are receiving any other investigational agents.
- •2.participants who are designated as unfit for receiving Abiraterone.
结局指标
主要结局
To compare the non inferiority of low dose abiraterone 250mg with low fat meal compared to hogh dose abiraterone 1000mg with in fasting state to improve 3 year PSA PFS in patients with hormone sensitive metastatic prostate cancer receiving Androgen deprivation therapy+docetaxel chemotherapy
时间窗: 3 year
次要结局
- 1. OS(2.Toxicity)