Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 8
- 主要终点
- Assess the epidemiological characteristics of the treated patient population
研究概览
简要总结
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.
bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
详细描述
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. Prostate cancer is the most common non-cutaneous cancer in men internationally, and more than 90% of patients with hormone-resistant prostate cancer will have bone metastases.
They frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.
Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.
There is therefore a need for bone-targeting therapeutic agents that provide a benefit in terms of survival.
Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who received treatment with XOFIGO in the framework of the AMM, in France since November 2013 are potentially eligible.
排除标准
- •Patients expressing a refusal to use this research data
结局指标
主要结局
Assess the epidemiological characteristics of the treated patient population
时间窗: during the treatment of XOFIGO an average of 24 weeks
clinical data collection in the medical record
次要结局
- assess the antalgic effet of treatment (number of antalgic taken and how many time)(during the treatment of XOFIGO an average of 24 weeks)
- Collect the causes of premature discontinuation of treatment(during the treatment of XOFIGO an average of 24 weeks)
- Assess the presence of adverse events resulting from short-term and medium-term XOFIGO treatment(during the treatment of XOFIGO an average of 24 weeks)
- Assess the number of patients who were able to benefit from the complete treatment (6 cycles)(during the treatment of XOFIGO an average of 24 weeks)
- assess the overall survival(during the treatment of XOFIGO an average of 24 weeks)