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
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