{"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. 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.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00699751","url":"https://clinicaltrials.gov/study/NCT00699751"},{"label":"NICE TA412: radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases","url":"https://www.nice.org.uk/guidance/ta412"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["targeted-alpha-therapy"],"targets":[],"drugs":["radium-223"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":["prostate-crpc-sequencing","prostate-uk-drug-approvals"],"trials":["era-223","peace-3"],"people":["oliver-sartor","karim-fizazi"],"bottlenecks":[],"keyPapers":["paper-alsympca-radium-223-nejm-2013"],"journals":[],"dependsOn":[],"notes":["In England NICE TA412 recommends radium-223 dichloride for hormone-relapsed prostate cancer with symptomatic bone metastases and no known visceral metastases, only if the man has already had docetaxel or docetaxel is contraindicated or unsuitable, and only with the patient access scheme discount. Two subsequent trials define how it should be combined: ERA 223 found that adding it to abiraterone without mandatory bone protection produced fractures in 29 against 11 percent and no benefit, while PEACE-3, with enzalutamide and with bone-protecting agents mandatory for everyone from March 2018, found median overall survival 38.2 against 32.6 months (hazard ratio 0.76, 95 percent confidence interval 0.60 to 0.96)."],"nct":"NCT00699751","phase":"3","setting":"Symptomatic bone-metastatic CRPC without visceral disease: radium-223 vs placebo","sponsor":"Bayer / Algeta","result":"OS HR 0.70.","started":"2008-06-12","startedType":"actual","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":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/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/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"term":[{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"},{"id":"prostate-crpc-sequencing","kind":"term","name":"What follows what in castration-resistant prostate cancer","route":"/terms/prostate-crpc-sequencing/"}],"trial":[{"id":"era-223","kind":"trial","name":"ERA 223","route":"/trials/era-223/"},{"id":"peace-3","kind":"trial","name":"PEACE-3 (EORTC 1333)","route":"/trials/peace-3/"},{"id":"vision","kind":"trial","name":"VISION","route":"/trials/vision/"}],"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/"}]}}