Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- miRNA and novel hormonal agent (NHA)
研究概览
简要总结
Several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in France. The oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. It is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. It shows why resistant mechanisms to treatment need to be elucidated. MicroRNA (miR) are short RNA, implicated in messenger ribonucleic acid (mRNA) regulation. Evidence is emerging that miR is implicated in prostate cancer response to treatment. It would be interesting to determine if a miR profile can predict treatment response to chemotherapy and/or to novel hormonal agents.
详细描述
Several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in France. The oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. It is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. It shows why resistant mechanisms to treatment need to be elucidated. MicroRNA (miR) are short RNA, implicated in messenger ribonucleic acid (mRNA) regulation. Evidence is emerging that miR is implicated in prostate cancer response to treatment. It would be interesting to determine if a miR profile can predict treatment response to chemotherapy and/or to novel hormonal agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •prostate adenocarcinoma
- •metastatic disease, proven (CT or bone scintigraphy or MRI or positron emission tomography(PET)-CT or X ray)
- •castration resistance, proven with biology or radiologic progression
- •affiliated to a french social security regimen
排除标准
- •other cancer within five years
- •any judiciary protection measure
研究组 & 干预措施
1- Chemotherapy
Intervention : one blood sample is done before beginning chemotherapy as a first treatment line for a metastatic castration resistant prostate cancer
干预措施: Blood sample (Biological)
2- Novel Hormonal Agent
Intervention : one blood sample is done before beginning a novel hormonal agent (abiraterone, enzalutamide) as a first treatment line for a metastatic castration resistant prostate cancer
干预措施: Blood sample (Biological)
结局指标
主要结局
miRNA and novel hormonal agent (NHA)
时间窗: 30 months
miRNA expression profile predicting resistance to novel hormonal agents
miRNA and chemotherapy
时间窗: 30 months
miRNA expression profile predicting resistance to chemotherapy
次要结局
- miRNA and progression free survival (PFS)(30 months)
- miRNA in tissue sample(30 months)
- miRNA and overall survival (OS)(30 months)