Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 Concomitantly With Abiraterone or Enzalutamide in First Line Setting : A Retrospective Chart Abstraction Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Bayer
- 主要终点
- Survival rates
研究概览
简要总结
There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mCRPC and bone metastases
- •≥ 40 years of age at diagnosis of mCRPC
- •Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed)
- •Receipt of at least one cycle of radium-223 after 15 May 2013
- •First cycle of Ra-223 occurs while receiving first line treatment with abi/enza
- •Treated with abi/enza for at least 28 days (1 cycle) following initiation of Ra-223
- •Initiation of Ra-223 at least 6 months after the start of treatment with abi/enza
- •Completion of Ra-223 treatment prior to the receipt of any chemotherapy for mCRPC
- •At least 12 months of follow-up (or until death) from date of initiation of Ra-223
- •Known date of death (if patient deceased)
排除标准
- •Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC
- •Active participant in an interventional clinical trial for CRPC in first line
- •Presence of visceral metastases at initiation of Ra-223 treatment
- •Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease
研究组 & 干预措施
Radium-223 concomitant with Abiraterone or Enzalutamide
Approximately 150 medical charts from mCRPC patients within the network will be collected
干预措施: Zytiga (Drug)
Radium-223 concomitant with Abiraterone or Enzalutamide
Approximately 150 medical charts from mCRPC patients within the network will be collected
干预措施: radium Ra 223 dichloride (Xofigo, BAY88-8223) (Drug)
Radium-223 concomitant with Abiraterone or Enzalutamide
Approximately 150 medical charts from mCRPC patients within the network will be collected
干预措施: Xtandi (Drug)
结局指标
主要结局
Survival rates
时间窗: Up to 1 year
Survival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjects
次要结局
- Disease progression(Up to 1 year)
- Skeletal related events (SRE)(Up to 1 year)
- Symptomatic Skeletal Events (SSE)(Up to 1 year)
- Time to death(Up to 1 year)
- Sequence of treatment regimens(Up to 1 year)
- Dose schedule(Up to 1 year)
- Time to first visceral metastasis(Up to 1 year)
- Proportion of patients developing visceral metastasis(Up to 1 year)
- Duration of therapy(Up to 1 year)