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临床试验/NCT02518698
NCT02518698已完成不适用

Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases

Bayer0 个研究点目标入组 1,163 人开始时间: 2015年8月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
1,163
主要终点
Overall survival of mCRPC patients

研究概览

简要总结

The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
55 Years 至 88 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
  • Members age ≥ 55 to 89 years at index
  • Medicare members with medical and pharmacy coverage; and
  • Continuously enrolled during the pre- and post-index periods.

排除标准

  • Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
  • Members age ≥ 89 years of age at index date

研究组 & 干预措施

Cohort 1 / Treatment patterns

Patients with castrated resistant prostate cancer and bone metastases

干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)

结局指标

主要结局

Overall survival of mCRPC patients

时间窗: Up to 24 months

mCRPC: Metastatic castrate-resistant prostate cancer

Number of skeletal related events (SREs) of the mCRPC patients

时间窗: Up to 30 months

Duration for each treatment identified

时间窗: Up to 30 months

Clinical and demographic characteristics of the mCRPC patients

时间窗: Up to 12 months

Gender, age, geographical region and race/ethnicity, Key comorbidities will also be documented using the Deyo-Charlson Comorbidity Index (DCCI); laboratory results for Prostate-Specific Antigen (PSA) and alkaline phosphatase (ALP) testing using laboratory claims; Rx utilization including opioid use

Type of skeletal related events (SREs) of the mCRPC patients

时间窗: Up to 30 months

Number of patients with mCRPC with bone metastases

时间窗: Up to 24 months

Type of treatments associated with mCRPC

时间窗: Up to 24 months

Treatments could include chemotherapy or bone radiation

Distribution of providers by treatment

时间窗: Up to 30 months

Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)

Treatment patterns of mCRPC patients with bone metastases

时间窗: Up to 30 months

Progression of the disease of mCRPC patients

时间窗: Up to 12 months

次要结局

  • All-cause healthcare resource utilization for mCRPC patients(Up to 30 months)
  • mCRPC-specific healthcare costs for mCRPC patients(Up to 30 months)
  • All-cause healthcare costs for mCRPC patients(Up to 30 months)
  • mCRPC-specific healthcare resource utilization for mCRPC patients(Up to 30 months)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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