NCT02899104已完成不适用
Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223
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
- 200
- 试验地点
- 1
- 主要终点
- Determining factors that drive physician decision for treatment selection.
研究概览
简要总结
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
详细描述
This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
- •Patients were at least 18 years of age as of the first diagnosis for mCRPC.
- •Patients must have received at least one intravenous injection of Radium-223 (Xofigo).
- •First injection of Radium-223 must have started between periods
- •1-January-2014 to 30-June-2014 or 15-November-2014 to present.
- •Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.
排除标准
- •Patients who received Radium-223 as part in an interventional clinical trial
- •Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.
研究组 & 干预措施
Radium-223 dichloride
Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223.
干预措施: Xofigo (Radium-223 dichloride, BAY88-8223) (Drug)
结局指标
主要结局
Determining factors that drive physician decision for treatment selection.
时间窗: Up to 9 months
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression.
次要结局
- Most common treatment sequences(Up to 9 months)
- Integration of Xofigo into the common treatment sequences, monotherapy or in combination.(Up to 9 months)
- Mean Xofigo dose(Up to 9 months)
- Duration of Xofigo treatment(Up to 9 months)
- Overall survival (OS)(Up to 9 months)
- Time to radiographic progression(Up to 9 months)
- Time to PSA (Prostate specific antigen) progression(Up to 9 months)
- Most common SRE (Skeletal Related Event)(Up to 9 months)
- Most common clinical intervention(Up to 9 months)
- Time to first SSE(Symptomatic Skeletal Events)(Up to 9 months)
- Reasons for discontinuation(Up to 9 months)
- Change in laboratory values from baseline(Up to 9 months)
- Radiological progression free survival (rPFS)(Up to 9 months)
- Time to alkaline phosphatase (ALP) progression(Up to 9 months)
- Time to visceral metastasis(Up to 9 months)
- Time to onset of first subsequent treatment(Up to 9 months)
- Pain(Up to 9 months)
- Most common symptoms(Up to 9 months)
- Type of physician(Up to 9 months)
- Change in PSA from baseline to 12 weeks, and baseline to discontinuation(Baseline and 12 weeks,Baseline and through study completion, an average of 1 year)
- Resource utilization(Up to 9 months)
- Change in ALP from baseline to 12 weeks, and baseline to discontinuation(Baseline and 12 weeks,Baseline and through study completion, an average of 1 year)
- Change in LDH from baseline to 12 weeks, and baseline to discontinuation(Baseline and 12 weeks,Baseline and through study completion, an average of 1 year)
研究者
研究点 (1)
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