NCT01215526已完成不适用
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 45
- 主要终点
- To estimate the progression-free survival (PFS) failure rate
研究概览
简要总结
Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy
排除标准
- •Patients with a contraindication for prescription of Firmagon®
结局指标
主要结局
To estimate the progression-free survival (PFS) failure rate
时间窗: Maximum 3 years
次要结局
- To prescribe the change in patient's quality of life (QoL) during therapy.(From study start and after 6 months)
- To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects(Every 3 months (during 3 years))
- To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy(From study start, after 3 months and at end of treatment)
- To assess the reduction of prostate volume (neoadjuvant therapy)(Fom baseline after 3 months)
研究者
研究点 (45)
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