{"entity":{"id":"alphabreak","kind":"trial","name":"AlphaBreak (FPI-2265) & AcTION (225Ac-PSMA-617)","aka":[],"tldr":"The phase 3 trials that will decide whether alpha-emitting PSMA drugs become the next step after Pluvicto.","summary":"AlphaBreak and AcTION, led by trial NCT06402331, are the phase 3 trials that will decide whether alpha-emitting PSMA drugs become the next step after Pluvicto in PSMA-positive metastatic castration-resistant prostate cancer. AlphaBreak tests FPI-2265, an actinium-225 PSMA-I&T agent from AstraZeneca and Fusion, after lutetium PSMA therapy, while Novartis' AcTION programme tests actinium-225 PSMA-617 in post-lutetium and lutetium-naive settings, and Bayer's PAnTHA phase 1 of 225Ac-PSMA-Trillium reported at ASCO GU 2026; the record lists an enrolment target of 600. OnCo links them to targeted alpha therapy, the actinium-225 PSMA agents record, and to Fusion, AstraZeneca, Novartis and Bayer. Both are recruiting with no results, dry mouth and actinium-225 supply are the constraints, and whether alpha emitters help after lutetium is the question they exist to answer.","status":"active","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT06402331","url":"https://clinicaltrials.gov/study/NCT06402331"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["targeted-alpha-therapy"],"targets":[],"drugs":["ac225-psma"],"companies":["fusion-pharma","astrazeneca","novartis","bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06402331","phase":"2","setting":"PSMA-positive mCRPC: actinium-225 PSMA radioligands vs standard of care, including after 177Lu-PSMA","sponsor":"AstraZeneca (Fusion); Novartis","started":"2024-03-05","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing phase 3 of 225Ac-PSMA-I&T after 177Lu-PSMA; no results."},"route":"/trials/alphabreak/","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":"ac225-psma","kind":"drug","name":"Actinium-225 PSMA agents","route":"/drugs/ac225-psma/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"},{"id":"fusion-pharma","kind":"company","name":"Fusion Pharmaceuticals (AstraZeneca)","route":"/companies/fusion-pharma/"},{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}]}}