Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 676
- 试验地点
- 88
- 主要终点
- duration of the PSA progression-free survival
研究概览
简要总结
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA) progression during the Firmagon® therapy is to be documented and related to the testosterone values measured in the course of therapy (if available). Other clinical parameters, the patients' quality of life and the direct and indirect costs incurred by the medical care for the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In this context the medical outcome and the life quality are defined as effectiveness and benefit value parameters. Both the effectiveness under daily life circumstances and economic variables of the therapy can thus be shown and compared within an analysis of costs vs. benefits or costs vs. effectiveness.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •therapeutic need according to SPC
- •written informed consent
排除标准
- •contraindications according to SPC
结局指标
主要结局
duration of the PSA progression-free survival
时间窗: open (until therapy end or stop)
次要结局
- 2. number of ADRs and SUSARs(open (until therapy end or stop))
- 3. quality of life(open (until therapy end or stop))
- 1. testosterone levels(open (until therapy end or stop))