Phase 1 Trial: 177Lu-PSMA-617 Plus Darolutamide in High-Risk Localized Prostate Cancer

A new trial phase 1 trial is investigating the combination of 177Lu-PSMA-617 (Pluvicto) with darolutamide in high-risk localized prostate cancer.Both agents are already established in prostate cancer care, but using them together before surgery is a novel way to intensify treatment in patients whose disease is still potentially curable.

Its main idea is simple: attack the cancer before prostatectomy, when the tumor burden is still localized but the risk of hidden spread is high. 177Lu-PSMA-617 delivers targeted radiation to PSMA-expressing cells, while darolutamide blocks androgen signaling, which prostate cancer cells depend on for growth and survival. The hope is that this dual approach will shrink the tumor more deeply, improve pathologic response, and reduce the chance of early recurrence.

Clinical trial.