Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer (CHRONOS3)
2019年7月24日 更新者：Ipsen
A Non-interventional, Multi-centric, Observational, Prospective Study to Collect the Criteria on Which Renewal of GnRH Analogue Treatment With Triptorelin (Diphereline 3.75mg or Diphereline pr 11.25mg) is Made in Patients Recently Diagnosed With Prostate Cancer Requiring Androgen Deprivation Therapy
The purpose of this study is to collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.
研究概览
研究类型
观察性的
注册 (实际的)
368
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arad、罗马尼亚
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Bucharest、罗马尼亚
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Cluj-Napoca、罗马尼亚
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Constanta、罗马尼亚
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Craiova、罗马尼亚
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Iasi、罗马尼亚
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Timisoara、罗马尼亚
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.
描述
Inclusion Criteria:
- Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation
- Expected survival > 12 months.
- Patients having provided written informed consent.
- Patients mentally fit for completing a questionnaire.
Exclusion Criteria:
- Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study.
- Patients who already have been treated with a GnRH analogue within the last year.
- Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients.
- Patients with a contraindication according to SmPC.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Prostate cancer patients
Patients recently diagnosed with prostate cancer requiring ADT.
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This is an observational study.
Thus, the treatment selection with triptorelin (Diphereline® or Diphereline PR®) is at investigator's discretion based on the current practice principles and guidelines/protocols, in accordance with the Summary of Product Characteristics (SmPC) approved in Romania by the National Medicines Agency.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.
大体时间：1 month
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To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at 1-month +/- 7 days for Diphereline 3.75mg.
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1 month
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Percentage of patients for whom the initial GnRH analogue formulation has been renewed.
大体时间：3 months
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To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at at 3-months +/- 10 days for Diphereline PR 11.25mg (Visit 2).
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit
大体时间：6 and 12 months
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To evaluate the percentage of patients for whom the initial GnRH formulation (triptorelin-Diphereline®) had been renewed at each follow up visit [Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)].
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6 and 12 months
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Percentage of patients that switched from a 1-month to a 3-months formulation
大体时间：3, 6, 12 months
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To evaluate the percentage of patients having switched from a 1-month to a 3-months formulation at each visit [Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)].
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3, 6, 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2019年6月6日
研究完成 (实际的)
2019年6月6日
研究注册日期
首次提交
2014年9月2日
首先提交符合 QC 标准的
2014年9月10日
首次发布 (估计)
2014年9月12日
研究记录更新
最后更新发布 (实际的)
2019年7月25日
上次提交的符合 QC 标准的更新
2019年7月24日
最后验证
2019年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.