NCT00871585已完成不适用
Non-interventional Observational Study to Evaluate Change of PSA Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide in Combination With Medical or Surgical Castration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- To evaluate change in PSA level following 4-9 months of bicalutamide therapy
研究概览
简要总结
Prospective, non-comparative, non-interventional, observational study to collect and analyse real life environment data on advanced prostate cancer patients receiving combination treatment of medical or surgical castration and bicalutamide according to routine medical practice in Croatia. The main aim is to evaluate change of PSA level and prescribing practices based on prostate cancer stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of advanced prostate cancer
- •Patients who are already treated with bicalutamide for at least 4 weeks and maximum 12 weeks
- •Patients capable of signing ICF
排除标准
- •Patients with hypersensitivity to bicalutamide
- •Patients on therapy with terfenadin, astemizol or cisapride
- •Participation in a clinical study during the last 30 days
结局指标
主要结局
To evaluate change in PSA level following 4-9 months of bicalutamide therapy
时间窗: PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide)
次要结局
- bicalutamide prescribing practice based on prostate cancer stage(1 measure (at the time of bicalutamde th introduction))
- to evaluate PSA level after 4-12 weeks of bicalutamide therapy(PSA - 1 measures (1-3 m following bicalutamide))
- to asses time to disease progression based on PSA values(PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide))
- to evaluate percentage of patients with disease progression(2 measures at 1st and 2nd visit)
- to evaluate withdrawals due to adverse events(2 measures, at 1st and 2nd visit)
- to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription(2 measures, at 1st and 2nd visit)
研究者
研究点 (1)
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