ALSYMPCA is the trial that won approval for the first alpha-emitting drug.
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. OnCo 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.
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 |
Shares ALSYMPCA: alpha emitter radium-223 and survival in metastatic prostate cancer with bone metastases, Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares Karim Fizazi, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Bayer, Prostate cancer.
Shares A. Oliver Sartor, VISION, What follows what in castration-resistant prostate cancer, Metastatic castration-resistant prostate cancer.
Shares Bayer, Targeted alpha therapy, Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares A. Oliver Sartor, Karim Fizazi, VISION, Metastatic castration-resistant prostate cancer.
Shares VISION, What follows what in castration-resistant prostate cancer, Metastatic castration-resistant prostate cancer, Prostate cancer.
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Bayer, Prostate cancer.
Shares Karim Fizazi, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Prostate cancer.