ALSYMPCA
ALSYMPCA is the trial that won approval for the first alpha-emitting drug.
Overview
ALSYMPCA, trial NCT00699751 sponsored by Bayer and Algeta and reported in 2013, is the trial that won approval for radium-223, the first alpha-emitting drug. It randomised 921 men with symptomatic bone-metastatic castration-resistant prostate cancer and no visceral disease to radium-223 or placebo, met its primary overall survival endpoint and reduced skeletal events. Nuclide links it to prostate cancer, targeted alpha therapy, radium-223 dichloride, A. Oliver Sartor and Karim Fizazi; it was a single pivotal trial, and the later ERA 223 combination with abiraterone was harmful, so use is now restricted to monotherapy in bone-predominant disease. Whether targeted alpha emitters such as actinium-225 PSMA agents can go further than a bone-seeking radium ever could is the question its legacy poses. Radium-223 has its own page.
- 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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Radium-223 | 614 | 14.9 months | 0.7 (0.58 to 0.83) | <0.001 | link |
| Placebo | 307 | 11.3 months |
Similar pages
not linked directly; found by shared links- PairingRadium-223 with abiraterone: a caution, not a combination
Shares Karim Fizazi, Radium-223 dichloride, Radium-223, Metastatic castration-resistant prostate cancer.
- PersonChris C. Parker
Shares ALSYMPCA: alpha emitter radium-223 and survival in metastatic prostate cancer with bone metastases, Radium-223, Metastatic castration-resistant prostate cancer, Prostate cancer.
- Key paperPhase I dose-escalation study of 225Ac-J591, a PSMA-targeting alpha-emitting antibody, in mCRPC
Shares A. Oliver Sartor, Metastatic castration-resistant prostate cancer, Targeted alpha therapy, Actinium-225.
- TrialAlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617)
Shares Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline, Metastatic castration-resistant prostate cancer, Targeted alpha therapy, Actinium-225.
- AgentSamarium-153 lexidronam
Shares Bone pain palliation from osteoblastic metastases, Radium-223 dichloride, Radium-223, Prostate cancer.
- Key paperPSMAfore: 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor in taxane-naive mCRPC
Shares Karim Fizazi, A. Oliver Sartor, Metastatic castration-resistant prostate cancer.
- CompanyFull-Life Technologies
Shares Metastatic castration-resistant prostate cancer, Targeted alpha therapy, Actinium-225.
- IsotopeStrontium-89
Shares Bone pain palliation from osteoblastic metastases, Radium-223, Prostate cancer.