A Phase II Randomised, Placebo-controlled, Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections
Primary objective:
To study the biological effectiveness of radium-223 therapy measured as
- Time to occurrence of skeletal-related events(SREs)
- Change in bone-specific alkaline phosphatase (bone-ALP) levels
Secondary objectives:
To study the efficacy of radium-223 therapy in terms of:
- Frequency of new SREs
- Proportions of patients with an SRE
- Proportions of patients with SRE at different time points
- Changes of biochemical markers of bone turnover
- Treatment response with regard to pain and analgesic use(termed "Palliative effect" in
study protocol)
- Quality of life assessment
- Overall survival
To study the safety of the repeated radium-223 regimen.
Total Enrollment:64 Study start: February 2004
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Change in Bone-ALP levels from baseline to 4 weeks after last injection
Sten Nilsson, MD
Principal Investigator
Radiumhemmet, Karolinska Hospital, Stockholm, Sweden
Sweden: Medical Products Agency
BC1-02
NCT00459654
February 2004
May 2007
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