Treatment Patterns in Metastatic Prostate Cancer
2018年1月24日 更新者：Bayer
Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .
This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives).
Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective).
The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.
研究概览
研究类型
观察性的
注册 (实际的)
565
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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New Jersey
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Whippany、New Jersey、美国
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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
45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
Part 1 - Assessment of treatment patterns, healthcare resource utilization, and costs The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
Part 2 - Assessment of mortality The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
描述
Inclusion Criteria:
- Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:
- At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR
- At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims.
Exclusion Criteria:
- Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period.
- Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
- Patients who had a SRE in the 12-month pre-index period.
- Subjects without continuous enrollment for at least 12 months before the index date.
- Subjects without continuous eligibility for at least 6 months after the index date.
- Subjects that are female.
- Subjects that have negative costs.
- Subjects that are less than 45 years of age on the index date.
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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Treatment patterns, healthcare resource utilization and costs
Part 1 - Assessment of treatment patterns, healthcare resource utilization and costs.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no skeletal-related events (SREs) in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before and at least 6 months after the index date.
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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Mortality
Part 2 - Assessment of mortality.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no SREs in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before the index date.
Unlike in Part 1, there will be no required minimum follow-up time after the index date (in order to assess mortality).
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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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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Distribution of treatment types among lines of therapy
大体时间：Up to 6 months
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Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Time to treatment (days)
大体时间：Up to 6 months
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Up to 6 months
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Duration of treatment (days)
大体时间：Up to 6 months
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Up to 6 months
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Number of patients on each drug or drug combination
大体时间：Up to 6 months
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Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Number of inpatient visits per patient
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Length of hospital stay (days) among those with an inpatient visit
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Number of outpatient visits per patient
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Number of emergency room (ER) visits per patient
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Number of physician office visits per patient
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Number of medication prescriptions per patient
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Number of patients by provider type
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Number of claims per patient
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Total costs of healthcare
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Medical costs of healthcare
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Pharmacy costs of healthcare
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Per-patient-per-month (PPPM)) costs of healthcare
大体时间：Upto 6 month post index period
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Upto 6 month post index period
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Mortality rate
大体时间：Up to 6 months
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Up to 6 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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Opioid/analgesic use among lines of therapy(Y/N)
大体时间：Up to 6 months
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Opioid and analgesics use among lines of therapy (e.g.
1st, 2nd, 3rd)
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Up to 6 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 (实际的)
2016年10月31日
初级完成 (实际的)
2017年1月19日
研究完成 (实际的)
2017年1月19日
研究注册日期
首次提交
2016年3月16日
首先提交符合 QC 标准的
2016年3月31日
首次发布 (估计)
2016年4月6日
研究记录更新
最后更新发布 (实际的)
2018年1月25日
上次提交的符合 QC 标准的更新
2018年1月24日
最后验证
2018年1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.
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