A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Correlate level of tumor oxygenation with prostate volume
研究概览
简要总结
Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.
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
- •Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project
- •informed consent
排除标准
- •Coagulopathy
研究组 & 干预措施
hypoxia measurement
Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy
干预措施: hypoxia measurement (Procedure)
结局指标
主要结局
Correlate level of tumor oxygenation with prostate volume
时间窗: 8 weeks
prostate volume measurement
Correlate level of tumor oxygenation with hemoglobin level
时间窗: 8 weeks
hemoglobin test (g/L)
Correlate level of tumor oxygenation with PSA level
时间窗: 8 weeks
PSA test (ug/L)
To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
时间窗: 8 weeks
Trans-rectal ultrasound and measurement of tumor oxygenation
次要结局
- To study of the effect of neoadjuvant anti-androgen therapy on prostate tumour histopathology and gene expression, and correlation of these effects with changes in oxygenation.(8 weeks)