64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer: A Prospective, Non-randomized, Single Arm, Single Center, Open-label Phase 1/2 Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To assess safety of 64Cu-SAR-bisPSMA (all patients).
研究概览
简要总结
This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.
详细描述
This is a prospective, non-randomized, single arm, single center, open-label study of 64Cu-SAR-bisPSMA PET in patients with known or suspected prostate cancer (PC).
Patients will be screened during a 28-day period and assessed against the inclusion and exclusion criteria. During screening the investigator will determine the patient's disease status (for patients with suspected prostate cancer) or stage of disease (for patients with known prostate cancer) and management plan based on the available standard of care test results (including available imaging, histopathology, biochemical markers, clinical and symptoms history, etc.). Eligible patients will receive a single administration of 64Cu-SAR-bisPSMA and complete a PET scan at an early time (1-4 hours) and a late time (24-72 hours).
The patient's status will only be assessed in patients with suspected disease at study entry and will be characterized as suspected or known prostate cancer during the follow up.
Staging will only be assessed in patients with known prostate cancer at study entry and will be characterized according to the TNM system and as Localized, Regional or Distant (nodes/visceral/bone).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Signed an informed consent.
- •>18 years of age.
- •Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy.
- •The Eastern Cooperative Oncology (ECOG) performance status 0-
- •Adequate recovery from acute toxic effects of any prior therapy.
- •Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher)
排除标准
- •Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.
- •Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.
- •Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
- •Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
结局指标
主要结局
To assess safety of 64Cu-SAR-bisPSMA (all patients).
时间窗: From injection of 64Cu-SAR-bisPSMA to one week following.
To assess treatment emergent adverse events.
次要结局
- Disease status adjustment (patients with suspected disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.(Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging)
- Clinical Management plan before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.(Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging)
- Disease Staging adjustment (for patients with known disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.(Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging)
研究者
Luke Nordquist, MD
Sponsor/Principal Investigator
GU Research Network, LLC