# ALSYMPCA

Source: https://nuclide.cc/trials/alsympca/  
Nuclide record `alsympca` (Trial). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

ALSYMPCA is the trial that won approval for the first alpha-emitting drug.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-06
- Registry id: NCT00699751
- Phase: 3
- Setting: Symptomatic bone-metastatic CRPC without visceral disease: radium-223 vs placebo
- Sponsor: Bayer / Algeta
- Enrolled: 921
- Result: OS HR 0.70.
- Outcomes: Overall survival: Radium-223 14.9 months vs Placebo 11.3 months, HR 0.7
- Replication: Single pivotal trial; the ERA 223 combination with abiraterone was harmful, so use is now restricted to monotherapy in bone-predominant disease.

## Sources

- ClinicalTrials.gov NCT00699751: https://clinicaltrials.gov/study/NCT00699751

## Connected records

- isotopes: [Actinium-225](https://nuclide.cc/isotopes/ac-225/), [Radium-223](https://nuclide.cc/isotopes/ra-223/)
- indications: [Bone pain palliation from osteoblastic metastases](https://nuclide.cc/indications/bone-pain-palliation/), [Metastatic castration-resistant prostate cancer](https://nuclide.cc/indications/prostate-mcrpc/), [Prostate cancer](https://nuclide.cc/indications/prostate/)
- technologies: [Targeted alpha therapy](https://nuclide.cc/technologies/targeted-alpha-therapy/)
- drugs: [Radium-223 dichloride](https://nuclide.cc/drugs/radium-223/)
- people: [A. Oliver Sartor](https://nuclide.cc/people/oliver-sartor/), [Karim Fizazi](https://nuclide.cc/people/karim-fizazi/)
- key papers: [ALSYMPCA: alpha emitter radium-223 and survival in metastatic prostate cancer with bone metastases](https://nuclide.cc/key-papers/paper-alsympca-radium-223-nejm-2013/)
- fronts: [Bone-targeted radiopharmaceuticals](https://nuclide.cc/fronts/f-bone-targeted/), [Targeted alpha therapy](https://nuclide.cc/fronts/f-alpha-therapy/)
- roadmaps: [Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline](https://nuclide.cc/roadmaps/alpha-therapy-roadmap/)

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JSON: https://nuclide.cc/api/v1/entities/alsympca.json