Prospective Multicenter Observational Program for Evaluation of Efficacy and Tolerability of the 6-month Depot Eligard 45 mg in Patients With Advanced Prostate Carcinoma in Routine Clinical Practice of Uro-Oncologists in the Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 645
- 试验地点
- 52
- 主要终点
- Percentage change in total serum PSA
研究概览
简要总结
Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in several clinical trials. However, clinical trials are limited by strict patient inclusion and exclusion criteria. Therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month LA depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation.
This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of patients, demographic patient data, diagnosis and diagnostic findings in patients. It will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •All male patients > 18 years of age with advanced PCa to whom oncourologist decided to prescribe Eligard 45 mg
排除标准
- •Patient participation in any clinical trials.
研究组 & 干预措施
Patients with advanced prostate carcinoma
干预措施: Eligard 45 mg Exposure (Drug)
结局指标
主要结局
Percentage change in total serum PSA
时间窗: Baseline and every 6 months until 24 months after treatment start
Percentage change in testosterone levels
时间窗: Baseline and every 6 months until 24 months after treatment start
次要结局
- Number of adverse drug reactions(Baseline to 24 months after treatment start)
- Mean change in QoL based on EuroQOL five dimensions questionnaire (EQ-5D)(Baseline to 24 months after treatment start)
