Dr Mota on Using Darolutamide to Enhance PSMA Expression in Localized Prostate Cancer

“The trial was declared positive, and, per protocol analysis, 3 patients achieved the primary end point.”

Jose Mauricio Mota, MD, PhD, the chief of the Genitourinary Medical Oncology Service at Instituto do Câncer do Estado de São Paulo, discussed data from the phase 2 Daro-PET trial (NCT05900973), which he presented in a poster during the 2026 Genitourinary Cancers Symposium.

Daro-PET was a single-arm study that evaluated whether short-course darolutamide (Nubeqa) could increase PSMA expression levels in 16 patients with high-risk localized prostate cancer, Mota began. The primary end point of the trial was the proportion of patients with an increase in SUV max from PSMA-PET 1 to PSMA-PET 2 of at least 20%.

Treatment in the trial was found to be feasible and well tolerated, with all patients completing therapy, Mota explained. Three patients (18.8% [90% CI, 5.3%-41.7%]) in the intention-to-treat (ITT) population achieved the primary end point and the study was declared positive per protocol analysis, he added. Additionally, 7 patients (50% [90% CI, 26.4%-73.6%]) in the per-protocol population (n = 14) had an increase in tumor volume, he said.

Further data from the study demonstrated that 5 patients in the per-protocol population achieved an SUVmax increase and 3 patients experienced an SUVmax increase of at least 20%. No new pelvic or extrapelvic metastases were detected following treatment with darolutamide.

Disclosures: Mota received honoraria from Amgen, Astellas Pharma, AstraZeneca, Bayer, Ipsen, Janssen, Merck, Novartis, Pfizer, and Zodiac Pharma; holds consulting or advisory roles with Astellas Pharma and Janssen Oncology, serves on the speakers’ bureaus of Amgen, Astellas Pharma, AstraZeneca, Bayer, Ipsen, Janssen Oncology, Merck, Novartis, Pfizer, and Zodiac Pharma; received research funding from Bayer; provided expert testimony for Adium Pharma, Astellas Pharma, and Bayer; and received travel, accommodations, and/or expenses from Janssen Oncology and Zodiac Pharma.