Utility of Ga-68-PSMA-11 in Management of Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Concurrence with Conventional Imaging
研究概览
简要总结
The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.
详细描述
Participants (male veterans) with initial diagnosis of prostate cancer or biochemically recurrent disease that consent to participate in the study will receive both conventional imaging (MRI, CT, and/or molecular imaging bone scan) as well as Ga-68-PSMA-11 PET/CT. Following baseline assessment (Visit #1), Ga-68-PSMA-11 (3-7 mCi) will be administered as a single intravenous administration with PET/CT performed approximately 60 minutes after injection (Visit #2A). At approximately 120 minutes after injection of Ga-68-PSMA-11, the final evaluation for safety and tolerability will occur (Visit #2B)
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
- •Able to tolerate PET/CT imaging and one or more of the following:
- •Patients with newly diagnosed prostate cancer with primary staging classified at high/intermediate risk per NCCN guidelines OR
- •Biochemical Recurrence: Patients with rising PSA after definitive therapy with prostatectomy or radiation therapy or other local therapies
排除标准
- •Claustrophobia or any other condition that would preclude PET/CT imaging.
- •Any constellation of medical conditions that indicate expectancy of less than one year
研究组 & 干预措施
Ga-68-PSMA-11 PET/CT
Administration of Ga-68-PSMA-11 and acquisition of PET/CT
干预措施: Ga-68-PSMA-11 (Drug)
结局指标
主要结局
Concurrence with Conventional Imaging
时间窗: Up to 28 days
Localized vs extra-pelvic recurrence will be determined for each patient based on Ga-68-PSMA-11 PET/CT and standard-of-care radiological imaging
次要结局
未报告次要终点
研究者
Timothy Hoffman
Research Career Scientist
Harry S. Truman Memorial Veterans' Hospital