Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Differences in optimal clinical management
研究概览
简要总结
This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.
详细描述
Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts.
Primary endpoint:
- Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.
Secondary endpoints:
- 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
- Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.
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
- •Age 18 years or older
- •Previously diagnosed with prostate cancer, under referring physician's care
- •ECOG performance status 0 - 3, inclusive
- •Able to understand and provide written informed consent
- •Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection
- •Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:
- •Gleason score > 7
- •Serum PSA > 15 ng/ml
- •T stage of T3 or greater on TNM staging
- •Equivocal/inconclusive conventional staging such as CT, MRI or bone scan
- •Clinical suspicion of advance stage disease (e.g. bone pain)
- •Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.
排除标准
- •Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- •Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
- •Patients with unmanageable claustrophobia
结局指标
主要结局
Differences in optimal clinical management
时间窗: 30 days
Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.
次要结局
- Adverse events(2 hours)
- Scan positivity fraction in BCR by PSA.(30 days)
研究者
Stephan Probst, MD
Chief of Nuclear Medicine
Sir Mortimer B. Davis - Jewish General Hospital