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[ 177 Lu]Lu-PSMA-617 vs cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): A randomised, open-label, phase 2 trial

The Lancet Feb 15, 2021

Hofman MS, Emmett L, Sandhu S, et al. - Researchers performed this multicenter, unblinded, randomized phase 2 trial in Australia to compare lutetium-177 [ 177 Lu]Lu-PSMA-617 vs cabazitaxel as a treatment choice for patients suffering from metastatic castration-resistant prostate cancer. This analysis involved males experiencing metastatic castration-resistant prostate cancer for whom cabazitaxel was thought to be the next suitable standard treatment. The presence of adequate renal, hematological, and liver function, and an Eastern Cooperative Oncology Group performance status of 0–2 was necessary for inclusion in the study. Men were randomized 1:1 to [ 177 Lu]Lu-PSMA-617 (6.0–8.5 GBq intravenously every 6 weeks for up to six cycles) or cabazitaxel (20 mg/m 2 intravenously every 3 weeks for up to ten cycles). Prostate-specific antigen (PSA) response, defined by a decrease of at least 50% from baseline, was considered as the primary endpoint. Findings revealed that a higher PSA response and fewer grade 3 or 4 adverse events was associated with treatment with [ 177 Lu]Lu-PSMA-617 vs cabazitaxel in men suffering from metastatic castration-resistant prostate cancer. [ 177 Lu]Lu-PSMA-617 represents a novel effective class of therapy as well as affords a potential alternative to cabazitaxel.

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