Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,472
- 主要终点
- Number of Participants With Second Primary Malignancies (SPM)
研究概览
简要总结
Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study
- •Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
- •Signed informed consent
排除标准
- •Previously treated with Radium-223 for any reason
- •Currently treated in clinical trials including other Radium-223 studies
- •Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use
研究组 & 干预措施
Radium-223 dichloride (Xofigo, BAY88-8223)
Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Number of Participants With Second Primary Malignancies (SPM)
时间窗: From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223
Second primary malignancies (SPMs) are defined as new malignancies unrelated to prostate cancer or progression of prostate cancer. All types of SPMs will be collected irrespectively of their relationship to Radium-223. All reported SPMs will be summarized as assessed by the physician
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
时间窗: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
Number of Participants With Drug-related Treatment-emergent Adverse Events
时间窗: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
Number of Participants With Drug-related SAEs
时间窗: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks), up to 7 years after the last dose of Radium-223
All drug-related SAEs were collected up to 7 years after the last administration of radium-223.
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression
时间窗: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after last dose of Radium-223
Bone marrow suppression relevant treatments for participants with subsequent chemotherapy (e.g., blood transfusion/erythropoietin/colony growth stimulating factors)
Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression
时间窗: From last Radium-223 dose up to 6 months post last dose of Radium-223
Hematological toxicities were summarized by the Common Terminology Criteria for Adverse Events (CTCAE) coding system and the worst grade. The grading system ranges from Grade 1 (mild) to Grade 5 (death). The percentage of participants with post-radium-223 treatment CTCAE grade 3 or 4 hematological toxicities that occurred within 183 days from last radium-223 injection are reported
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC)
时间窗: From 30 days after last dose of Radium-223 up to 6 months after last dose
Participants with a platelet count or WBC less than the lower limit of normal at 6 months post last dose of Radium- 223
Bone Marrow Suppression: Number of Participants Who Underwent Subsequent Chemotherapy That Experienced Febrile Neutropenia or Hemorrhage
时间窗: From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy
Participants who receive subsequent cytotoxic chemotherapy were followed for the development of febrile neutropenia and hemorrhage up to 6 months after the last administration of chemotherapy at a frequency based on local clinical practice.
次要结局
- Overall Survival(From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223)
- Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire(From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after the last dose of Radium-223)
- The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire(From initiation of Radium-223 (treatment period up to 6 months which includes 4 cycles every 4 weeks) up to 6 months after the last dose of Radium-223)
- Percentage of Participants With Bone Fractures(From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223)
- Percentage of Participants With Bone Associated Events(From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223)