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临床试验/DRKS00024134
DRKS00024134已完成未知

Prospective evaluation of the DEtection rate of clinically significant PROstate cancer by mpMRI and PSMA-PET/CT fusion biopsy - DEPROMP

Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn0 个研究点目标入组 246 人开始时间: 2021年1月26日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
246

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
45 Years 至 75 Years(—)
性别
Male

入选标准

  • The patient is suspected of having a localised prostate carcinoma based on at least one of the following criteria, so that clarification by means of MRI fusion punch biopsy is indicated:
  • PSA-value = 4 ng/ml or
  • suspicious tactile findings of the prostate in the digital rectal examination or
  • suspicious findings in transrectal sonography
  • patients must be = 45 years and < 76 years old
  • patients must be biopsy-naive
  • patient gives documented written consent to participate in the study
  • patients who are able to follow the study instructions and who are likely to adhere to all required study visits (compliance)

排除标准

  • The patient has a PSA level elevation of >100 ng/ml with resulting suspicion of advanced metastatic prostate carcinoma
  • The patient has a serious kidney disease, defined by Estimated creatinine clearance < 30 ml/min (using a site-specific method)

研究者

发起方
Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn

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