NCT04593420已完成不适用
Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 817
- 试验地点
- 1
- 主要终点
- Proportion of subjects treated continuously with triptorelin for the 12 months
研究概览
简要总结
The purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France.
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
- •At least 18 years old
- •Histologically confirmed prostate cancer
- •Triptorelin to be initiated in its labelled indication for a planned total duration of at least 12 months; decision to start triptorelin was made voluntarily by the physician as part of routine medical practice, prior to the inclusion in the study
- •Ability to understand and complete questionnaire,
排除标准
- •Previously received a hormonal therapy during the last 6 months before inclusion,
- •Simultaneously participates in a clinical trial.
结局指标
主要结局
Proportion of subjects treated continuously with triptorelin for the 12 months
时间窗: 12 months
The proportion of subjects treated continuously with triptorelin for the 12 months following treatment initiation, with any formulation and any route of administration. The treatment status (i.e. patient continuously treated / patient not continuously treated) will be assessed according to the investigator's judgment.
次要结局
- Description of the reasons of choice of formulation and administration route of triptorelin prescribed(baseline)
- Formulation and administration route of triptorelin prescribed(baseline, 6 and 12 months)
- Description and change at each follow-up visit from baseline(baseline, 6 months, 12 months)
- Planned total duration of triptorelin treatment(Baseline, 6 months, 12 months)
- Primary reasons of choice of planned total triptorelin treatment duration(baseline, 6 month, 12 months)
- Parameters that influence the planned total duration of triptorelin treatment(Baseline)
- Parameters that influence the choice of formulation and administration route of triptorelin prescribed(baseline)
- Parameters that influence the modification of the planned total duration of triptorelin treatment(12 months)
研究者
研究点 (1)
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