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临床试验/NCT04662996
NCT04662996
已完成
不适用

Search for Predictive Factors of Resistance to Treatment for Metastatic Castration-resistant Prostate Cancer by Studying the Expression of microRNAs

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 33 人2021年6月23日

概览

阶段
不适用
干预措施
Blood sample
疾病 / 适应症
Prostate Cancer
发起方
University Hospital, Tours
入组人数
33
试验地点
1
主要终点
miRNA and novel hormonal agent (NHA)
状态
已完成
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2021年6月23日
结束日期
2023年11月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

责任方
Sponsor

入排标准

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

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

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)

研究点 (1)

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