NCT01344564已完成不适用
Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Testosterone measurement
研究概览
简要总结
The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •18 years or older
- •Histologically confirmed adenocarcinoma of the prostate
- •Androgen deprivation therapy is indicated
排除标准
- •Baseline screening serum testosterone <150ng/dL
- •Eastern Cooperative Oncology Group (ECOG) score > 2
- •Diagnosed spinal or brain metastases
- •Hormonal manipulation within previous 6 months
研究组 & 干预措施
ADT
Other
All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.
干预措施: Degarelix acetate, Leuprolide acetate (Drug)
结局指标
主要结局
Testosterone measurement
时间窗: 11 times over 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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