EUCTR2018-002975-16-FR进行中（未招募）1 期
Phase III study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to compare the detection rate of prostate cancer lesions in patients with biochemical recurrence after previous definitive treatment for localized prostate cancer
ABX GmbH0 个研究点目标入组 188 人开始时间: 2018年9月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. male with original diagnosis of prostate carcinoma with prior definitive therapy
- •2. suspicion of recurrence
- •3. life expectancy of 6 months or more as judged by the investigator
- •4. willing and able to undergo all study procedures
- •5. informed consent in writing (dated and signed)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 88
排除标准
- •1. age: less than18 years
- •2. contraindications for F-18-Fluorocholine
- •3. contraindications for any of the ingredients of F-18-PSMA-1007
- •4. close affiliation with the investigational site; e.g. first-degree relative of the investigator
- •5. at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
- •6. having been previously enrolled in this clinical trial
- •7. mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- •8. being clinically unstable or requiring emergency treatment
研究者
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