A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET
研究概览
简要总结
This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography (PET) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able to see tumors at an earlier stage than the standard of care.
详细描述
PRIMARY OBJECTIVES:
I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ability to provide signed informed consent and willingness to comply with protocol requirements
- •Persistently elevated PSA
- •Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
- •Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection
排除标准
- •Participating would significantly delay the scheduled standard of care therapy
- •Administered a radioisotope within 10 physical half-lives prior to study drug injection
- •Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
研究组 & 干预措施
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.
干预措施: Copper Cu 64 TP3805 (Radiation)
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.
干预措施: Positron Emission Tomography and Computed Tomography Scan (Procedure)
结局指标
主要结局
Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET
时间窗: At 3 weeks post imaging visit
The proportion of participants with lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated.
次要结局
- Total Incidence of Multiple Lesions in an Individual Patient(At 3 weeks post imaging procedure)