ALSYMPCA
ALSYMPCA is the trial that won approval for the first alpha-emitting drug.
921 men; OS 14.9 vs 11.3 months (HR 0.70); fewer skeletal events.
Setting
Symptomatic bone-metastatic CRPC without visceral disease: radium-223 vs placebo
Phase
Phase 3
Sponsor
Bayer / Algeta
Registry
Headline result
OS HR 0.70.
Reported
2013
Enrolled
921
Replication
Single pivotal trial; the ERA 223 combination with abiraterone was harmful, so use is now restricted to monotherapy in bone-predominant disease.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 14.9 vs 11.3 months with Radium-223 compared with Placebo; about 3.6 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 30 percent lower chance of the event at any given time (hazard ratio 0.7, likely range 0.58 to 0.83).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Symptomatic bone-metastatic CRPC without visceral disease: radium-223 vs placebo. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
921 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Radium-223 | 614 | 14.9 months | 0.7 (0.58–0.83) | <0.001 | link |
| Placebo | 307 | 11.3 months |
Replication
Single pivotal trial; the ERA 223 combination with abiraterone was harmful, so use is now restricted to monotherapy in bone-predominant disease.Pages like this
not linked directly; found by shared links- TrialPEACE-1
Shares Karim Fizazi, Prostate cancer.
- TrialLATITUDE
Shares Karim Fizazi, Prostate cancer.
- PersonClemens Kratochwil
Shares Targeted alpha therapy, Prostate cancer.
- TermBone metastases and skeletal-related events
Shares Radium-223 dichloride, Prostate cancer.
- CompanyAktis Oncology
Shares Targeted alpha therapy, Prostate cancer.
- TechnologyBone-modifying agents (bisphosphonates, denosumab)
Shares Radium-223 dichloride, Prostate cancer.
- TrialAlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617)
Shares Targeted alpha therapy, Prostate cancer.
- InstitutionQST Hospital (National Institutes for Quantum Science and Technology)
Shares Targeted alpha therapy, Prostate cancer.