{"entity":{"id":"alsympca","kind":"trial","name":"ALSYMPCA","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00699751","url":"https://clinicaltrials.gov/study/NCT00699751"}],"tags":[],"related":["ac-225","ra-223"],"indications":["prostate","prostate-mcrpc"],"sections":[],"technologies":["targeted-alpha-therapy"],"targets":[],"drugs":["radium-223"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["oliver-sartor","karim-fizazi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00699751","phase":"3","setting":"Symptomatic bone-metastatic CRPC without visceral disease: radium-223 vs placebo","sponsor":"Bayer / Algeta","result":"OS HR 0.70.","yearReported":2013,"enrolled":921,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Radium-223","n":614,"value":14.9},{"name":"Placebo","n":307,"value":11.3}],"hr":0.7,"ci":[0.58,0.83],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1213755"}],"replication":"Single pivotal trial; the ERA 223 combination with abiraterone was harmful, so use is now restricted to monotherapy in bone-predominant disease."},"route":"/trials/alsympca/","neighbours":{"isotope":[{"id":"ac-225","kind":"isotope","name":"Actinium-225","route":"/isotopes/ac-225/"},{"id":"ra-223","kind":"isotope","name":"Radium-223","route":"/isotopes/ra-223/"}],"indication":[{"id":"bone-pain-palliation","kind":"indication","name":"Bone pain palliation from osteoblastic metastases","route":"/indications/bone-pain-palliation/"},{"id":"prostate-mcrpc","kind":"indication","name":"Metastatic castration-resistant prostate cancer","route":"/indications/prostate-mcrpc/"},{"id":"prostate","kind":"indication","name":"Prostate cancer","route":"/indications/prostate/"}],"technology":[{"id":"targeted-alpha-therapy","kind":"technology","name":"Targeted alpha therapy","route":"/technologies/targeted-alpha-therapy/"}],"drug":[{"id":"radium-223","kind":"drug","name":"Radium-223 dichloride","route":"/drugs/radium-223/"}],"person":[{"id":"oliver-sartor","kind":"person","name":"A. Oliver Sartor","route":"/people/oliver-sartor/"},{"id":"karim-fizazi","kind":"person","name":"Karim Fizazi","route":"/people/karim-fizazi/"}],"paper":[{"id":"paper-alsympca-radium-223-nejm-2013","kind":"paper","name":"ALSYMPCA: alpha emitter radium-223 and survival in metastatic prostate cancer with bone metastases","route":"/key-papers/paper-alsympca-radium-223-nejm-2013/"}],"section":[{"id":"f-bone-targeted","kind":"section","name":"Bone-targeted radiopharmaceuticals","route":"/fronts/f-bone-targeted/"},{"id":"f-alpha-therapy","kind":"section","name":"Targeted alpha therapy","route":"/fronts/f-alpha-therapy/"}],"roadmap":[{"id":"alpha-therapy-roadmap","kind":"roadmap","name":"Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline","route":"/roadmaps/alpha-therapy-roadmap/"}]}}