Overall survival with Lu-PSMA-617 versus cabazitaxel for mCRPC in the randomized phase 2 TheraP trial

Lutetium-177 (¹⁷⁷Lu)-PSMA-617 is a radiolabelled small molecule that delivers β radiation to cells expressing prostate-specific membrane antigen (PSMA). The randomized phase 2 trial TheraP, at 11 centers in Australia, randomized patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), progressing after docetaxel, to ¹⁷⁷Lu-PSMA-617 or cabazitaxel. In 2021 the primary analysis of the trial was reported, showing that the ¹⁷⁷Lu-PSMA-617 group had higher PSA response and fewer grade 3 or 4 adverse events. Final analysis of the trial no shows that overall survival was similar in both groups (p=0.77). The authors conclude that these results support the use of ¹⁷⁷Lu-PSMA-617 as an alternative to cabazitaxel for PSMA-positive mCRPC. Median overall survival was shorter for men who were excluded because of low PSMA expression.