Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Thomas Hope
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
研究概览
简要总结
The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.
详细描述
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues
Primary Objective:
Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
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, age >=
- •Histopathologically proven prostate adenocarcinoma.
- •Concern for metastatic disease in one of the following settings:
- •Initial staging with intermediate to high risk prostate cancer.
- •Biochemical recurrence after initial therapy.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.
研究组 & 干预措施
Ga-68 labeled PSMA-11 PET PSMA
The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.
干预措施: Ga-68 labeled PSMA-11 (Drug)
Ga-68 labeled PSMA-11 PET PSMA
The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.
干预措施: Positron emission tomography-computed tomography (PET/CT) (Device)
Ga-68 labeled PSMA-11 PET PSMA
The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.
干预措施: Positron emission tomography-magnetic resonance imaging (PET/MRI) (Device)
结局指标
主要结局
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
时间窗: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group
时间窗: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group
时间窗: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group
时间窗: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group
时间窗: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
次要结局
未报告次要终点
研究者
Thomas Hope
Principal Investigator
University of California, San Francisco