Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 23
- 主要终点
- Evaluation of tolerability of treatment on a 4 point scale
研究概览
简要总结
Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients.
Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study.
There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient.
Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.
排除标准
- 未提供
研究组 & 干预措施
Prostate Cancer patients
干预措施: Depo-Eligard® (Drug)
结局指标
主要结局
Evaluation of tolerability of treatment on a 4 point scale
时间窗: Last Visit (after at least 180 days of treatment)
次要结局
- Investigator satisfaction with treatment(Last Visit (after at least 180 days of treatment))
- Overall patient's assessment of treatment benefit(Last Visit (after at least 180 days of treatment))
- Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule(Day 1 and Last Visit (after at least 180 days of treatment))
- Efficacy of treatment(Day 1 and Last Visit (after at least 180 days of treatment))
- Occurrence of Adverse Drug Reactions(Day 1 and Last Visit (after at least 180 days of treatment))
- Changes in quality of life of subjects as measured by EORTC QLQ-C30(Day 1 and Last Visit (after at least 180 days of treatment))