NCT04102553已完成3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine
研究概览
简要总结
This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •male with original diagnosis of prostate carcinoma with prior definitive therapy
- •suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
- •life expectancy of 6 months or more as judged by the investigator
- •willing and able to undergo all study procedures
- •informed consent in writing (dated and signed)
排除标准
- •age: less than18 years
- •contraindications for F-18-Fluorocholine
- •contraindications for any of the ingredients of F-18-PSMA-1007
- •close affiliation with the investigational site; e.g. first-degree relative of the investigator
- •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
- •having been previously enrolled in this clinical trial
- •mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- •being clinically unstable or requiring emergency treatment
- •being considered a vulnerable person
研究组 & 干预措施
F-18-PSMA-1007
Experimental
Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT.
干预措施: F-18-PSMA-1007 (Drug)
F-18-PSMA-1007
Experimental
Patients will receive F-18-PSMA-1007 PET/CT first, followed by F-18-Fluorocholine PET/CT.
干预措施: F-18-Fluorocholine (Drug)
F-18-Fluorocholine
Active Comparator
Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT.
干预措施: F-18-PSMA-1007 (Drug)
F-18-Fluorocholine
Active Comparator
Patients will receive F-18-Fluorocholine PET/CT first, followed by F-18-PSMA-1007 PET/CT.
干预措施: F-18-Fluorocholine (Drug)
结局指标
主要结局
To compare detection rate of metastatic prostate cancer lesions of F-18-PSMA-1007 versus F-18-Fluorocholine
时间窗: Within 6 months after PET/CT
次要结局
未报告次要终点
研究者
研究点 (6)
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