2025-520571-66-00招募中3 期
CYPENZA - A prospective cohort trial on antiandrogens influences on the pharmacokinetics of corticosteroids.
Region Vaesterbotten1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The difference in the AUC (area under curve) of dexamethasone serum concentration before, and after steady-state, of two different antiandrogens (enzalutamide or apalutamide).
研究概览
简要总结
To assess the extent to which the antiandrogens (enzalutamide and apalutamide) influence the pharmacokinetics of the administered corticosteroid dexamethasone.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed prostate cancer
- •Intended to begin treatment with antiandrogen therapy, -enzalutamide or apalutamide-
- •Can understand all the requirements of the trial, provide informed consent, and provide authorization of use and disclosure of personal health information
- •WHO performance status 0-1
排除标准
- •Treatment with systemic corticosteroids (ongoing or last 4 weeks), inhalations steroids, topical steroids or nasal steroids are not regarded as systemic therapies
- •Treatment with health product modulating CYP3A4
- •Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)
- •Diabetes (defined as diagnosed diabetes type I or type II)
- •Previous seizure in medical history
- •Other serious illness or medical condition according to the investigator, e.g., other cancer, history of peptic ulcer, or bipolar disorder.
结局指标
主要结局
The difference in the AUC (area under curve) of dexamethasone serum concentration before, and after steady-state, of two different antiandrogens (enzalutamide or apalutamide).
The difference in the AUC (area under curve) of dexamethasone serum concentration before, and after steady-state, of two different antiandrogens (enzalutamide or apalutamide).
次要结局
- To assess whether doubling the corticosteroid dose can compensate for any reduction of the AUC by antiandrogen therapy (enzalutamide or apalutamide).
- To evaluate possible adverse events of giving a single dose dexamethasone at three separate occasions.
- To evaluate the AUC following administration of a doubled dose of dexamethasone during ongoing treatment with antiandrogens (enzalutamide or apalutamide).
研究者
Sarah Jonsson
Scientific
Region Vaesterbotten
研究点 (1)
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