跳至主要内容
临床试验/NCT02128334
NCT02128334已完成不适用

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

Astellas Pharma Europe B.V.52 个研究点 分布在 1 个国家目标入组 645 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (52)

Loading locations...

相似试验

An Observational Study Looking at How Well the Drug... | 临床试验