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Sandy Srinivas, MD


ESMO 2023: Phase II Results With Enzalutamide Plus Radioligand Therapy in Prostate Cancer

By: Celeste L. Dixon
Posted: Tuesday, October 31, 2023

As first-line treatment in metastatic castration-resistant prostate cancer, adaptive-dosed lutetium-177–prostate-specific membrane antigen–617 (LuPSMA) together with the androgen receptor pathway inhibitor enzalutamide demonstrated more anticancer activity than enzalutamide alone, according to the results of a randomized phase II trial presented at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract LBA84). Louise Emmett, MD, of Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia, and colleagues also noted that serious adverse events were reported in 33% of patients assigned to the combination therapy vs 35% of those given enzalutamide alone.

All participating patients had metastatic castration-resistant prostate cancer not previously treated with chemotherapy or an androgen receptor pathway inhibitor; prior abiraterone and/or docetaxel for hormone-sensitive disease were allowed and had been taken by 13% and 54% of participants, respectively. They also had PET-confirmed 68-Ga–PSMA–positive disease and at least two risk factors associated with early disease progression on enzalutamide.

A total of 162 patients were randomly assigned (1:1) either to enzalutamide at 160 mg/day alone or enzalutamide at 160 mg/day plus adaptive-dosed LuPSMA at 7.5 GBq on days 15 and 57; two further doses of LuPSMA were given if 68-Ga–PSMA PET revealed persistent PSMA-positive disease on day 92. Most of the 83 patients (81%) in the LuPSMA arm received four doses.

PSA progression-free survival was a median of 13 months with enzalutamide plus LuPSMA vs 7.8 months with enzalutamide alone. Similarly, the PSA 50% and 90% response rates were higher with enzalutamide plus LuPSMA vs enzalutamide alone: 93% vs 68% and 78% vs 37%, respectively.

Disclosure: For full disclosures of the study authors, visit

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