NCT04742361已完成3 期
Phase III Study of [18F]PSMA-1007 Positron Emission Tomography for the Detection of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 6
- 主要终点
- Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
研究概览
简要总结
This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 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
- Na
- 干预模型
- Single Group
- 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 adenocarcinoma of the prostate with prior definitive therapy
- •Suspicion of recurrence or persistence
- •after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
- •after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
- •For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
- •Life expectancy of 6 months or more as judged by the investigator
- •Willing and able to undergo all study procedures
- •Informed consent in writing
排除标准
- •Age: less than18 years
- •Contraindications to any of the ingredients of [18F]PSMA-1007
- •Close affiliation with the investigational site
- •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
- •Patients who are unwilling to consider a biopsy if clinically recommended
- •Patients who are unable to undergo a PET/CT scan
- •Patients for whom systemic therapy is the most likely course regardless of PET findings.
研究组 & 干预措施
[18F]PSMA-1007
Experimental
single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan
干预措施: [18F]PSMA-1007 (Drug)
结局指标
主要结局
Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
时间窗: Within 6 months after PET/CT
Patient-level correct detection rate of [18F]PSMA-1007
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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