NCT03017313已完成不适用
A Prospective Post Marketing Non Interventional Study to Evaluate the Criteria on Which Renewal of LHRH Analogue Treatment is Made in Patients With Prostate Cancer Locally Advanced or Metastatic.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 510
- 试验地点
- 27
- 主要终点
- Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
研究概览
简要总结
The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed
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
- •Adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy with a 3 or 6 month LHRH analogue including those requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with radiotherapy
- •Patients having provided written informed consent
- •Patients mentally fit for completing a self-administrated questionnaire
排除标准
- •Patients participating in another clinical study at the time of inclusion
- •Patients with another severe malignant disease
- •Life expectancy of less than 12 months
- •Patients already treated with a LHRH analogue within the last year
结局指标
主要结局
Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
时间窗: First follow-up visit (occurs 3 to 6 months from baseline)
次要结局
- Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.(Baseline)
- Percentage of patients starting a 6-month formulation at baseline.(Baseline)
- Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
- Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
- Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
- Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
- Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
- Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
- Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.(Baseline, between 3 to 6 months, 12 months, 18 months and 24 months)
研究者
研究点 (27)
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