A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Phase 3
Completed
NCT00699751
| Condition | Hormone Refractory Prostate Cancer, Bone Metastases |
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| Phase | Phase 3 |
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| Sponsor | Bayer |
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| Status | Completed |
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| Enrollment | 921 participants |
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| Interventions | Radium-223 dichloride (Xofigo, BAY88-8223), Best standard of care (BSoC) |
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| Start date | Jun 12, 2008 |
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| Completion date | Jul 15, 2011 |
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| Results posted | May 7, 2014 |
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Summary
ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.
Overall Survival
From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011) · Months
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 14.9 Months |
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| Placebo | 11.3 Months |
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| p-value | 0.00005 |
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| Hazard Ratio (HR) | 0.691 (95% CI 0.578–0.827) |
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Open in BENITIONS
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