EUCTR2016-004120-39-SE进行中（未招募）1 期
An experimental pilot study on immune and inflammatory biomarkers in patients with advanced prostatecancer treated with degarelix vs. GnRH agonist and with cardiovascular disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Region Skåne
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •18 years of age or above
- •Patients with advanced prostate cancer and scheduled for androgen deprivation treatment for at least 8 weeks
- •Patients with a history of cardiovascular disease according to specified criteria
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Current or prior use in the past 6 months of androgen deprivation therapy
- •Prior use of dutasteride/finasteride or antiandrogen in the past 6 months
- •Ongoing diagnosed chronic or immune disease
- •Known or suspected allergy to medications used in the study
- •QT-interval at ECG>450 ms
- •Subject has total bilirubin >= 1.5 x ULN (except subjects with Gilberts disease), or alanine aminotransferase (ALT) or aspartate aminotransferase >= 2.5 x ULN at screening
- •Creatine > 2 mg/dL (177 umol) at screening
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