Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer.
研究概览
简要总结
With functional imaging development, it becomes possible to increase radiation dose to radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role in the resistance of these tumors to radiation.
In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we should characterize changes in hypoxia before treatment and during radiotherapy.
- If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by an "integrated" boost is performed.
- If hypoxia varied (increasing or incomplete regression), a "final" boost strategy of radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a first fractionated IMRT could be considered.
This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available tool to physicians in assessing tumor hypoxia.
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 proven prostate adenocarcinoma
- •Absence of metastases (lymph node or bone)
- •One or more tumor nodules seen on MRI and PET Choline.
- •Intermediate Risk : Gleason 7 and PSA (prostate specific antigen)<20 ng / ml, T <T2c or Gleason 6 and PSA 10-20 ng / ml, T <T2c
- •No concomitant hormonal treatment. (NB: the introduction of hormone therapy during radiotherapy before the second 18F-MISO is a criterion to study exit)
- •Indication of radiotherapy up to a total dose> 70 Gy and 2 Gy/day fractions
- •Signed Informed consent
- •Social Insurance
排除标准
- •Age < 18 years old
- •Patient protected by law
研究组 & 干预措施
PET imaging, 18 F-miso
Single Arm study
干预措施: 18-F-MISO (Drug)
结局指标
主要结局
To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer.
时间窗: 3 to 4 weeks after beginning of radiation therapy
First PET-scan with 18-F-Miso done before radiation Second PET-scan with 18-F-Miso done 3 to 4 weeks after the beginning of radiation therapy.
次要结局
- To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment.(before and 3 to 4 weeks after the begining of radiation therapy)