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
Overview
- Phase
- Phase 2
- Intervention
- Radium-223 dichloride (BAY88-8223)
- Conditions
- Hormone Refractory Prostate Cancer
- Sponsor
- Bayer
- Enrollment
- 100
- Primary Endpoint
- Analgesic consumption
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Radium-223 dichloride (BAY88-8223)
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.
Intervention: Radium-223 dichloride (BAY88-8223)
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.
Intervention: Radium-223 dichloride (BAY88-8223)
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.
Intervention: Radium-223 dichloride (BAY88-8223)
Outcomes
Primary Outcomes
Analgesic consumption
Time Frame: 16 weeks
Pain Assessment (using a 100mm Visual Analogue Scale)
Time Frame: 16 weeks
Secondary Outcomes
- 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)