ALSYMPCA
Radium-223 dichloride versus placebo, each with best standard of care, in castration-resistant prostate cancer with bone metastases
Phase 3N = 921NCT00699751
- Population
- Men with castration-resistant prostate cancer and bone metastases who had received, were not eligible to receive, or declined docetaxel
- Design
- Randomised (2:1), double-blind, placebo-controlled phase 3 trial of six injections of radium-223 (50 kBq per kilogram of body weight, one every 4 weeks) or matching placebo, each added to the best standard of care. A prespecified interim analysis at 314 deaths and an updated analysis at 528 deaths (before crossover from placebo to radium-223) were reported.
- Primary endpoint
- OS
- Arms
- Radium-223 plus best standard of care (experimental): Radium-223 dichloride 50 kBq per kilogram of body weight intravenously every 4 weeks for six injections, plus best standard of care
- Placebo plus best standard of care (control): Matching placebo every 4 weeks for six injections, plus best standard of care
- People
- Parker C
OSHR 0.70 (95% CI 0.55–0.88)Δ median OS+2.8 monthsOSHR 0.70 (95% CI 0.58–0.83)Δ median OS+3.6 months
Show the numbers
| Endpoint | Analysis | Radium-223 plus best standard of care | Placebo plus best standard of care | Effect |
|---|---|---|---|---|
| OSPatients in the prespecified interim analysis (n=809) | interimParker 2013 | median 14 months | median 11.2 months | HR 0.70 (95% CI 0.55–0.88)P=0.002Prespecified interim analysis involving 809 patients, conducted when 314 deaths had occurred; the abstract states the trial was terminated for efficacy at this interim analysis. |
| OSPatients in the updated analysis (n=921) | long term-updateParker 2013 | median 14.9 months | median 11.3 months | HR 0.70 (95% CI 0.58–0.83)P<0.001Updated analysis when 528 deaths had occurred, performed before crossover from placebo to radium-223. |
| Endpoint | Analysis | Radium-223 plus best standard of care | Placebo plus best standard of care | Effect |
|---|---|---|---|---|
| OSPatients in the prespecified interim analysis (n=809) | interimParker 2013 | median 14 months | median 11.2 months | HR 0.70 (95% CI 0.55–0.88)P=0.002Prespecified interim analysis involving 809 patients, conducted when 314 deaths had occurred; the abstract states the trial was terminated for efficacy at this interim analysis. |
| OSPatients in the updated analysis (n=921) | long term-updateParker 2013 | median 14.9 months | median 11.3 months | HR 0.70 (95% CI 0.58–0.83)P<0.001Updated analysis when 528 deaths had occurred, performed before crossover from placebo to radium-223. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.7 | 0.55–0.88 |
| OS | 0.7 | 0.58–0.83 |
- Radium-223 plus best standard of care (experimental)
- Placebo plus best standard of care (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Radium-223 plus best standard of care | Placebo plus best standard of care |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 9 | 64.0% | 57.3% |
| 18 | 41.0% | 32.8% |
| 26 | 27.6% | 20.0% |
| 35 | 17.7% | 11.5% |
- Radium-223 plus best standard of care (experimental)
- Placebo plus best standard of care (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Radium-223 plus best standard of care | Placebo plus best standard of care |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 9 | 65.8% | 57.6% |
| 19 | 41.3% | 31.2% |
| 28 | 27.2% | 18.0% |
| 37 | 17.9% | 10.3% |