A Double Blind, Dose Response Phase II, Multicentre Study of Radium 223 (Alpharadin®) for the Palliation of Painful Bone Metastases in Hormone Refractory Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 100
- 主要终点
- Analgesic consumption
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
详细描述
The study is designed to investigate whether there is a dose-response relationship for radium-223 in patients with painful bone metastases secondary to prostate carcinoma regarding palliation of bone pain. The palliative efficacy will be established through assessments of bone pain and consumption of analgesia. Furthermore, the aim is to find the most efficient dose with an acceptable safety profile. The safety will be assessed through measurements of adverse events, and acute haematological toxicity during the study period. Long-term chronic toxicity, and the overall survival at one and two years post treatment will also be assessed.
This is a double-blind, dose-response, randomized, multi-centre phase II efficacy and safety study of radium- 223. The clinical sites will enroll a total of 100 eligible patients. The treatment is a single intravenous administration of radium-223.
The target population is patients suffering from bone pain due to skeletal metastasis secondary to hormone refractory prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radium-223 dichloride (Xofigo, BAY88-8223)-5kBq/kg
Each patient received a single injection of radium-223 , based on the randomised dose level (5kBq/kg) and individual body weight.
A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
干预措施: Radium-223 dichloride (BAY88-8223) (Drug)
Radium-223 dichloride (Xofigo, BAY88-8223)-25 kBq/kg
Each patient received a single injection of radium-223 , based on the randomised dose level (25kBq/kg) and individual body weight.
A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
干预措施: Radium-223 dichloride (BAY88-8223) (Drug)
Radium-223 dichloride (Xofigo, BAY88-8223)-50 kBq/kg
Each patient received a single injection of radium-223 , based on the randomised dose level (50kBq/kg) and individual body weight.
A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
干预措施: Radium-223 dichloride (BAY88-8223) (Drug)
Radium-223 dichloride (Xofigo, BAY88-8223)-100 kBq/kg
Each patient received a single injection of radium-223 , based on the randomised dose level (100kBq/kg) and individual body weight.
A second injection of radium-223 set to 50 kBq/kg b.w. could be offered to patients in the Follow-up Period at the discretion of the investigator.
干预措施: Radium-223 dichloride (BAY88-8223) (Drug)
结局指标
主要结局
Analgesic consumption
时间窗: 16 weeks
Pain Assessment (using a 100mm Visual Analogue Scale)
时间窗: 16 weeks
次要结局
- The safety of radium-223: the total safety profile including adverse events and clinical laboratory measurements, with emphasis on haematological toxicity. Adverse events will be recorded continuously during the study period.(2 years)
- The date of death (if within 24 months after the injection of study drug)(2 years)
- Reduction of pain: the pain dimension of Quality of Life assessed using the Brief Pain Inventory (BPI) form, with total pain score and subtotals, after injection and compared to scores at baseline(16 weeks)
- Duration of pain relief: measured as the time between the first and last evaluation time points at which the pain response criteria were met(16 weeks)