{"entity":{"id":"therap","kind":"trial","name":"TheraP (ANZUP 1603)","aka":[],"tldr":"The randomised trial that first pitted a radioligand against chemotherapy and won on response, with fewer side effects.","summary":"TheraP, ANZUP trial 1603, NCT03392428, sponsored by ANZUP and Peter MacCallum and reported in 2021, was the randomised phase 2 that first pitted a radioligand against chemotherapy, comparing 177Lu-PSMA-617 with cabazitaxel in metastatic castration-resistant prostate cancer after docetaxel, with patients selected by PSMA and FDG PET. It randomised 200 men, met its primary endpoint with a PSA response of at least fifty percent in 66 percent of men against 37 percent, delayed progression and gave better quality of life with fewer side effects, but overall survival was similar in the 2024 analysis after crossover. Nuclide links it to radioligand therapy, PSMA PET, lutetium-177 vipivotide tetraxetan, cabazitaxel, Michael Hofman and the PSA50 term, and it is consistent with VISION on activity. The survival equivalence with cabazitaxel is the nuance that matters for sequencing, which remains open.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT03392428","url":"https://clinicaltrials.gov/study/NCT03392428"}],"tags":[],"related":["lu-177"],"indications":["prostate","prostate-mcrpc"],"sections":[],"technologies":["radioligand-therapy","psma-pet"],"targets":[],"drugs":["pluvicto","cabazitaxel"],"companies":[],"institutions":["peter-mac"],"pathways":[],"terms":["psa50"],"trials":[],"people":["hofman-michael"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03392428","phase":"2","setting":"mCRPC after docetaxel: 177Lu-PSMA-617 vs cabazitaxel, PSMA PET/FDG PET selected","sponsor":"ANZUP / Peter MacCallum","result":"PSA50 66% vs 37%; OS HR 0.97.","yearReported":2021,"enrolled":201,"enrolledBasis":"registry","outcomes":[{"endpoint":"PSA response ≥50%","primary":true,"unit":"%","arms":[{"name":"177Lu-PSMA-617","n":99,"value":66},{"name":"Cabazitaxel","n":101,"value":37}],"p":"<0.0001","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00237-3/fulltext"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"177Lu-PSMA-617","value":19.1,"note":"Not different"},{"name":"Cabazitaxel","value":19.6}],"hr":0.97,"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00529-6/fulltext"}],"replication":"Consistent with VISION on activity; the OS equivalence with cabazitaxel is an important nuance for sequencing."},"route":"/trials/therap/","neighbours":{"isotope":[{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}],"indication":[{"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":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"drug":[{"id":"cabazitaxel","kind":"drug","name":"Cabazitaxel","route":"/drugs/cabazitaxel/"},{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","route":"/drugs/pluvicto/"}],"institution":[{"id":"anzup","kind":"institution","name":"ANZUP Cancer Trials Group","route":"/institutions/anzup/"},{"id":"peter-mac","kind":"institution","name":"Peter MacCallum Cancer Centre","route":"/institutions/peter-mac/"}],"term":[{"id":"crossover","kind":"term","name":"Crossover in trials","route":"/terms/crossover/"},{"id":"psa50","kind":"term","name":"PSA50 / PSA90 response","route":"/terms/psa50/"}],"person":[{"id":"amir-iravani","kind":"person","name":"Amir Iravani","route":"/people/amir-iravani/"},{"id":"hofman-michael","kind":"person","name":"Michael Hofman","route":"/people/hofman-michael/"}],"idea":[{"id":"idea-rlt-plus-checkpoint-inhibitor","kind":"idea","name":"Adding a checkpoint inhibitor to PSMA radioligand therapy","route":"/ideas/idea-rlt-plus-checkpoint-inhibitor/"}],"paper":[{"id":"paper-hofman-lupsma-lancet-oncol-2018","kind":"paper","name":"LuPSMA trial: single-arm phase 2 study of 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer","route":"/key-papers/paper-hofman-lupsma-lancet-oncol-2018/"},{"id":"paper-therap-lancet-2021","kind":"paper","name":"TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer","route":"/key-papers/paper-therap-lancet-2021/"}]}}