uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- uPAR PET/CT imaging
研究概览
简要总结
The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with metastatic castration-resistant prostate cancer (mCRPC)
详细描述
68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/CT will be applied in patients with mCRPC during treatment with Radium-223. PET/CT will be performed before initiation of Radium therapy and after two treatment cycles. The initial semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in metastases as well as the change in these parameters after therapy will be correlated with overall survival and progression free survival.
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
- •Metastatic castration resistant prostate cancer
- •Approved to receive Radium-223 therapy
- •Written and oral consent
排除标准
- •Lack of communication skills
- •Other known malignant disease
- •Known allergy towards IMP
- •Severe claustrophobia
- •If a participant exhibits allergic reaction i the IMP, the participant will be excluded from further participation in the study
研究组 & 干预措施
uPAR PET/CT
Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks.
干预措施: Injection of PET tracer 68Ga-NOTA-AE105 (Drug)
uPAR PET/CT
Injection of 68Ga-NOTA-AE105 followed by PET/CT scan. Administration will be performed twice in approximately 8 weeks.
干预措施: PET/CT (Device)
结局指标
主要结局
uPAR PET/CT imaging
时间窗: 1 hour post injection
Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
Change in uPAR PET/CT after two cycles of Radium-223
时间窗: 8 weeks
Change in Standard uptake values (SUVs) of 68Ga-NOTA-AE105 evaluated on uPAR-PET/CT scan performed after 2 cycles of Radium-223 therapy
次要结局
- uPAR PET/CT as prognostic factor for overall survival(12 months)
- uPAR PET/CT as prognostic factor for progression free survival(12 months)
研究者
Marie Øbro Fosbøl
MD
Rigshospitalet, Denmark