68Ga-PSMA-11 PET in Patients With Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
详细描述
This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.
The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.
Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.
One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven prostate adenocarcinoma
- •Age ≥ 18 years
- •Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
- •Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):
- •a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of >0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.
- •Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
- •Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.
研究组 & 干预措施
Men with pathologically proven prostate adenocarcinoma
The intervention is a PET scan with the radiolabelled PSMA ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
干预措施: Ga-PSMA-11 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Immediately after administration and for 1 hour and 30 minutes afterwards
Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.
次要结局
- Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities.(2 hours)