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临床试验/NL-OMON25840
NL-OMON25840尚未招募不适用

Impact of peri-operative tEstosterone levels on oNcological and Functional Outcomes in RadiCal prostatEctomy (ENFORCE trial)

Canisius Wilhelmina Ziekenhuis0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Unmeasurable PSA after Radical Prostatectomy (RP)
  • 2.pT2-pT3a after RP
  • 3.ISUP 1-3 regardless of surgical margins
  • 4.ISUP 4-5 with negative surgical margins
  • 5.At least one-sided nerve-sparing procedure
  • 6.Baseline score sexual functioning domain of 40 points (EPIC-26)

排除标准

  • 1.Metastatic disease (cN1/M1)
  • 2.pT3b or pT4 after RP
  • 3.Prior treatment for PCa
  • 4.Prior TRT
  • 5.Medical history of male breast- or liver carcinoma
  • 6.Uncontrolled hypertension
  • 7.General contra-indication for testosterone replacement therapy
  • 8.Allergy for components in TRT-agent
  • 9.Use of vitamin K-antagonists
  • 10.BMI > 30

研究者

发起方
Canisius Wilhelmina Ziekenhuis

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