NCT02542501已完成不适用
A Prospective Post Marketing Non Interventional Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive LHRH Analogues and to Evaluate the Effect of LHRH Analogues on Lower Urinary Tract Symptoms (ANALUTS Study)
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
- 470
- 试验地点
- 32
- 主要终点
- The percentage of patients suffering from prostate cancer with moderate to severe LUTS (International prostate symptom score (IPSS) >7) at baseline and having at least 3 points reduction of IPSS score at the end of study (48 weeks).
研究概览
简要总结
The intention of this study is to investigate how many patients with prostate cancer, planned to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS symptoms over time will be investigated.
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
- •Adult men with locally advanced or metastatic prostate cancer scheduled to receive LHRH analogues. A patient who has completed an IPSS questionnaire in his last visit, before the start of LHRH analogues, will be able to participate in the study. This last visit has to be done 6 months before the baseline visit.
- •Patients having provided written informed consent
- •Patients mentally fit for completing a self-administered questionnaire
排除标准
- •Any surgical or radiotherapy treatment performed at prostate level before the entry of the study
- •Patient with castrate levels of testosterone ( < 50 ng/dL) at his first IPSS questionnaire
- •Patients who are also participating in any other clinical study within the last 2 months before study entry
- •Life expectancy of less than 12 months
结局指标
主要结局
The percentage of patients suffering from prostate cancer with moderate to severe LUTS (International prostate symptom score (IPSS) >7) at baseline and having at least 3 points reduction of IPSS score at the end of study (48 weeks).
时间窗: Week 48
The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline.
时间窗: Baseline
次要结局
- The correlation between IPSS score changes and total PSA changes after 48 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7).(Week 48)
- The correlation between IPSS score changes and total prostatic-specific antigen (PSA) changes after 24 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7) at baseline.(Week 24)
- Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 48 to the percentage of patients presenting an IPSS ≥ 3 at baseline.(Week 48)
- The percentage of patients suffering from prostate cancer with moderate to severe LUTS (score IPSS > 7) at baseline and having at least 3 points reduction of IPSS score at week 24.(Week 24)
- Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 24 to the percentage of patients presenting an IPSS ≥ 3 at baseline.(Week 24)
研究者
研究点 (32)
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