Phase II Trial: uPAR-PET/MR in Patients With Newly Diagnosed Prostate Cancer; Non-invasive Characterization of Tumor Aggressiveness
试验速览
- 阶段
- 2 期
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Correlation with Gleason Score
研究概览
简要总结
Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer 68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer
详细描述
Prostate cancer is one of the most frequent types of cancer in men. The characteristics of the disease varies significantly among patients where some have an indolent type of cancer, from which they will never experience symptoms while others have highly aggressive malignant disease that requires prompt therapeutic action.
Treatment of localized prostate cancer is based on a risk stratification, where patients are either offered therapy with curative intent - surgery or radiotherapy - or in case of low-risk disease an "active surveillance" strategy can be advised. In active surveillance the disease is monitored by PSA measurement, repeated biopsies and digital rectal examination. Some patients progress during active surveillance to a higher risk classification, which may lead to selection of active therapy.
The aim of this study is to investigate positron emission tomography (PET) with the radiolabelled tracer 68Ga-NOTA-AE105, combined with magnetic resonance imaging (MRI) in patients with newly diagnosed prostate cancer. 68Ga-NOTA-AE105 targets the receptor urokinase-type plasminogen activator receptor (uPAR), which is a known marker for aggressive disease in prostate cancer.
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
- •Histologically verified prostate cancer
- •Capable of understanding written information and giving informed consent
- •Planned to enter active surveillance strategy or undergo therapy with curative intent (surgery or radiotherapy)
排除标准
- •Obesity (Body weight over 140 kg)
- •Known allergy to 68-Ga-NOTA-AE105
- •Metallic components in the body that contradicts MRI scan
- •Severe claustrophobia making the person unable to complete an MRI scan
研究组 & 干预措施
uPAR PET/MRI
68Ga-NOTA-AE105 is injected once for performing a PET/MRI scan
干预措施: 68Ga-NOTA-AE105 (Drug)
结局指标
主要结局
Correlation with Gleason Score
时间窗: 3 months after PET/MRI
Correlate the uptake of 68Ga-NOTA-AE105 with Gleason Score obtained from biopsy material.
次要结局
- Prognostic value(3 years from PET/MRI)
- Diagnostic accuracy in staging lymph nodes(3 months from PET/MRI)
研究者
Marie Øbro Fosbøl
Medical doctor
Rigshospitalet, Denmark