NCT03014973撤回不适用
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Hopital Foch
- 试验地点
- 2
- 主要终点
- intra-prostatic concentration of sexual steroids
研究概览
简要总结
The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment
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
- 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
- •group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment
- •group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression
- •group 2a: without radiotherapy
- •group 2b: with radiotherapy
- •Affiliated to a social security scheme
- •Having given a written consent.
排除标准
- •Patient unable to supply a written consent (patient not understanding French, under guardianship patient).
- •neuro-endocrine form or sarcomatoid form prostate cancer
研究组 & 干预措施
prostate cancer patients resistant to castration
Experimental
干预措施: intra-prostatic concentration of sexual steroids (Biological)
prostate cancer patients resistant to castration
Experimental
干预措施: Trans-rectal biopsy (Procedure)
patients naif of hormonal treatment
Experimental
干预措施: intra-prostatic concentration of sexual steroids (Biological)
patients naif of hormonal treatment
Experimental
干预措施: Trans-rectal biopsy (Procedure)
结局指标
主要结局
intra-prostatic concentration of sexual steroids
时间窗: 2 weeks
次要结局
- Steroid 5-alphareductase RNA expression level(2 weeks)
- Androgen receptor immuno-histochemical expression level(2 weeks)
- Steroid aromatase immuno-histochemical expression level(2 weeks)
- Steroid aromatase RNA expression level(2 weeks)
- Androgen receptor RNA expression level(2 weeks)
- Steroid 5-alphareductase immuno-histochemical expression level(2 weeks)
研究者
研究点 (2)
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