Study to Assess the Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC) (REALIST-PRO)
2014年9月24日 更新者：Janssen Research & Development, LLC
Treatment Patterns in Metastatic Castration-Resistance Prostate Cancer (mCRPC): Real Life Analysis In Brazilian Oncology Centers (REALIST-PRO)
The purpose of this study is to assess the treatment patterns in participants with metastatic castration-resistant prostate cancer (mCRPC).
Additionally, participant's demographic and clinical characteristics, skeletal-related events, criteria used to define CRPC, prostate specific antigen (PSA) levels and pain related to disease and overall survival will be observed.
研究概览
详细说明
This is an observational (study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes), longitudinal (correlational research study that involves repeated observations of the same variables over long periods of time) and retrospective (study looking back over past experience) study to describe the treatment patterns in mCRPC.
Treatment patterns will be assessed by collecting medical charts from participants diagnosed with mCRPC in or prior 2009.
Primarily, percentage of participants who received therapy as first line treatment will be assessed.
All adverse events associated with the use of Sponsor drugs will be reported.
研究类型
观察性的
注册 (实际的)
382
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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Brasilia、巴西
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Curitiba、巴西
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Distrito Federal、巴西
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Florianopolis、巴西
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Goiania、巴西
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Ijuí、巴西
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Jau、巴西
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Porto Alegre、巴西
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Rio De Janeiro、巴西
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Sao Paulo、巴西
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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
Male participants with history of prostatic cancer and metastatic castration-resistant prostate cancer (mCRPC) from Brazil will be assessed.
描述
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Report of previous surgical or medical castration
- Castration-resistant prostate cancer (CRPC) diagnosis in or before 2009
- Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging in or before 2009. If lymph node metastasis is the only evidence of metastasis, it must be 2 centimeters (cm) in diameter
Exclusion Criteria:
- Participation in any investigational drug or device study or early access programme
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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Metastatic Castration-resistant Prostate Cancer
Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
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Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
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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 Participants Treated With Chemotherapy in First Line Therapy
大体时间：Day 1
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Participants treated with chemotherapy in first line therapy will be reported.
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Day 1
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Percentage of Participants Treated With Other Therapies in First Line Therapy
大体时间：Day 1
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Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in first line therapy will be reported.
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Day 1
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Percentage of Participants Treated With Chemotherapy in Second Line Therapy
大体时间：Day 1
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Participants who were treated with chemotherapy in second line therapy will be reported.
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Day 1
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Percentage of Participants Treated With Other Therapies in Second Line Therapy
大体时间：Day 1
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Participants treated with other therapies including secondary hormone therapy, steroids, radiation therapy, radionuclide therapy, bisphosphonates and best supportive care in second line therapy will be reported.
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Day 1
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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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Eastern Cooperative Oncology Group (ECOG) Performance Status
大体时间：Day 1
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ECOG performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (best) to grade 5 (worst).
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Day 1
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Number of Participants with Comorbidities
大体时间：Day 1
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Participants with comorbidities such as hypertension, diabetes, cardiac diseases, congestive cardiac failure, thyroid diseases and stroke will be reported.
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Day 1
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Blood Prostate Specific Antigen (PSA) levels
大体时间：Day 1
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Blood PSA levels will be reported.
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Day 1
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Number of participants With Bone or Visceral Metastasis
大体时间：Day 1
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Participants with bone or visceral metastasis will be reported.
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Day 1
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Assessment of Pain Related With Disease
大体时间：Day 1
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Pain will be assessed by reviewing the charts having information regarding pain (bone or other sites).
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Day 1
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Number of Participants With Gleason score
大体时间：Day 1
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Gleason scoring is used to grade tumors.
A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern.
The two grades are added together to get a GS.
Gleason grade range= 1-5; 5=worst prognosis.
GS range=2-10; 10=worst prognosis.
Improvement is defined as a decrease in GS from a Baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).
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Day 1
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Percentage of Participants With Skeletal Related Events (SREs)
大体时间：Day 1
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SREs include vertebral collapse, bone fractures, spinal cord compression, bone surgery and radiotherapy for bone complications.
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Day 1
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Number of Participants who were used to define mCRPC Criteria
大体时间：Day 1
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Participants with criteria used to define mCRPC as described by European Association of Urology (EAU) International Guidelines will be reported.
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Day 1
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Percentage of Participants Who Received Therapies After Second Line
大体时间：Day 1
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Participants who received therapies after second line will be reported.
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Day 1
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Overall Survival
大体时间：Day 1
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Day 1
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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。
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7月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2014年8月29日
首先提交符合 QC 标准的
2014年8月29日
首次发布 (估计)
2014年9月3日
研究记录更新
最后更新发布 (估计)
2014年9月25日
上次提交的符合 QC 标准的更新
2014年9月24日
最后验证
2014年9月1日
更多信息
与本研究相关的术语
其他研究编号
- CR100943
- 212082PCR0001 (其他标识符：Janssen Research & Development, LLC)
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.
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