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临床试验/NCT02235142
NCT02235142已完成不适用

Localised Cancer of Prostate and Androgen Deficiency.

Hopital Foch16 个研究点 分布在 3 个国家目标入组 1,614 人开始时间: 2013年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
1,614
试验地点
16
主要终点
Testosteron Serum level

研究概览

简要总结

Open study to make a comparison between hypogonadism and euogonadism patients regarding the severity of prostate cancer. The purpose of this study is to determine the importance of the relationship between the hormonal status and the type of the tumor at the time of surgical intervention as well as follow up of the patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Male patients over than 18 years of age, with localized, stage I or II prostate cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,...) or hormonal therapy, showing indication of radical prostatectomy.

排除标准

  • Absence of radical prostatectomy indication
  • Patient received local or hormonal therapy prior to surgery
  • Patients already enrolled in other clinical study incompatible with the study
  • Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride)

结局指标

主要结局

Testosteron Serum level

时间窗: The day prior to surgery

Gleason score

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (16)

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