Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in proliferation
研究概览
简要总结
The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control.
In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •biopsy-proven non-small cell lung cancer
- •surgical intervention planned
排除标准
- •current use of 5-alpha reductase inhibitor
- •previous diagnosis of prostate cancer
- •previous hypersensitivity to 5-alpha reductase inhibitor
研究组 & 干预措施
finasteride
finasteride 5mg po od from study entry to date of surgery
干预措施: finasteride 5mg oral daily (Drug)
结局指标
主要结局
Change in proliferation
时间窗: Original biopsy to surgical specimen (approx 6 weeks)
Patients will be followed from time of consent (around the time of consultation with a Thoracic Surgeon) to date of surgery (on average, approximately 4-6 weeks following Thoracic Surgeon consultation).
次要结局
未报告次要终点