PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 363
- 主要终点
- Pain response
研究概览
简要总结
This observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, 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
- •Adult male patients diagnosed with 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 or participating in another observational study with Xofigo
研究组 & 干预措施
Radium-223 dichloride
Male patients with a diagnosis of CRPC with symptomatic bone metastases without known visceral metastases will be enrolled after the decision for treatment with Radium-223 has been made by the attending physician according to his/her medical practice.
干预措施: Radium-223 dichloride, (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Pain response
时间窗: Up to 6 months
Determined by the worst pain item on the Brief Pain Inventory - Short Form (BPI-SF) patient questionnaire. A clinically meaningful pain response is defined as an improvement of two points from the baseline BPI-SF worst pain score at any post-baseline assessment.
次要结局
- Time to first pain progression(Up to 6 months)
- Summary description of covariates on pain response(Up to 6 months)
- Number of participants with Treatment-emergent Adverse Events (TEAE)(Up to 6 months)
- Overall survival(Up to 5.5 years)
- Bone Scan Index (BSI) as Imaging Biomarker in metastatic castration-resistant prostate cancer (mCRPC)(Up to 6 months)
- Change in bone pain related quality of life(Up to 6 months from baseline)
- Pain control rate(Up to 6 months)
- Pain progression rate(Up to 6 months)
- Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up(Up to 5.5 years)
- Time to first opioid use(Up to 5.5 years)
- Relation between bone uptake in known lesions and pain palliation(Up to 6 months)
- Course of blood count presented as percentage of patients below limit for further injections according to the local product information(Up to 5 months)
- Change of pain over time(Up to 6 months from baseline)
- Dosage of Radium-223(Up to 5 months)
- Number of injections of Radium-223(Up to 5 months)
- Time to next tumor treatment(s) (TTNT)(Up to 5.5 years)
- Time to first symptomatic skeletal event (SSE)(Up to 5.5 years)
- Time from castration resistance to treatment with Radium-223(First treatment)
- Effect of concomitant drug treatment on pain, quality of life, and overall survival(Up to 5.5 years)
- Description of covariates on duration of therapy(Up to 6 months)
- Factors positively influencing mCRPC patients to get ≥ 5 injections versus ≤ 4 injections(Up to 6 months)