ACTRN12614000689673终止2 期
The effects of estradiol on bone architecture and fat mass in men with prostate cancer
niversity of Melbourne0 个研究点目标入组 78 人开始时间: 2014年6月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 No limit 至 o limit（—）
- 性别
- Male
入选标准
- •1. Men with prostate cancer receiving gonadotropin-releasing hormone agonists or antagonists to suppress androgen production
- •2. Androgen Deprivation Therapy intended to continue for at least 6 months
- •3. Able and willing to comply with the study protocol requirements
排除标准
- •1. Bone metastases within imaging fields detectable by conventional imaging (e.g. CT scanning, bone scanning)
- •2. Significantly impaired performance status (ECOG > 2)
- •3. Previous history of deep vein thrombosis or pulmonary embolism
- •4. Stroke, transient ischaemic attack, myocardial infarction, or angina within the previous 12 months
- •5. New York Heart Association class 3-4 heart failure
- •6. Systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, or both.
- •7. Previous history of breast cancer
- •8. Current oral glucocorticoid therapy
- •9. Any current or previous antiresorptive therapy
- •10. Recreational drug use, alcohol dependence, known HIV/AIDS or any disease which is likely to lead to serious illness or death within the study period
- •11. Inability to understand sufficient English to give informed consent.
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