NCT02450812已完成不适用
URANIS -Data Collection in Urological Centers During Treatment With Ra-223 Dichloride (Xofigo) Within the Framework of a Non-interventional Study Assessing Overall Survival (OS) and Effectiveness Predictors of Ra-223 Dichloride Treated mCRPC Patients in a Real Life Setting in Germany.
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
- 86
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This observational prospective single arm cohort study is designed to assess overall survival, symptomatic skeletal event free survival and quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223 under real life conditions. In addition, time to next tumor treatment (TTNT), mobility, quality of life and selfcare, independence in activities of daily living and safety will be assessed.
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
- •Male patients diagnosed with castration resistant adenocarcinoma of the prostate (CRPC) with symptomatic bone metastases without known visceral metastases
- •Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice and also in all non-interventional studies focusing on Radium- 223-dichloride.
研究组 & 干预措施
Radium-223-dichloride (Xofigo, BAY88-8223)
patients with mCRPC with symptomatic bone metastases
干预措施: Radium-223-dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 60 months
次要结局
- Estimation of the non-pathological fractures(Up to 60 months)
- Estimation of the bone associated events(Up to 60 months)
- Estimation of the incidence of pathological fractures.(Up to 60 months)
- Time to next tumor treatment(s) (TTNT)(Up to 24 months)
- Quality of life as patient reported outcome estimated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire(Up to 60 months)
- Body function assessed in dimensions of "mobility", "self-care" and "domestic life" using the Medical Oncology Status in Europe Survey (MOSES) questionnaire(Up to 7 months)
- Evaluation of symptomatic skeletal event free survival (SSE-FS) of mCRPC patients(Up to 60 months)
- Incidence of treatment-emergent adverse events (TEAE)(Up to 30 days after last administration of Radium-223)
- Activities of daily living assessed according to the Katz-Index(Up to 7 months)
研究者
研究点 (1)
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