Daro-PET: PSMA PET After Short-Course Darolutamide in Prostate Cancer

In an interview with Targeted Oncology, Jose Mauricio Mota, MD, PhD, a medical oncologist at the University of São Paulo Institute of Cancer in Brazil, discussed the design, findings, and next steps for the phase 2 Daro-PET study (NCT05900973) presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium.

The ongoing Daro-PET study set out to evaluate the ability of the oral androgen receptor inhibitor darolutamide (Nubeqa) to enhance prostate-specific membrane antigen (PSMA) expression in 16 patients with high-risk localized prostate cancer.

Patients first underwent a PSMA PET scan to establish a baseline assessment of tumor activity. They then received darolutamide at the standard dose for 7 days, followed by a second PSMA PET scan to measure changes.

The treatment phase proved feasible and well tolerated, with 100% of enrolled patients completing both the 7-day course of therapy and follow-up imaging. The trial met its predefined primary end point, with 3 of the 16 enrolled patients achieving the primary outcome. Per protocol analysis showed 3 of 14 evaluable patients met the end point criteria. Based on these findings, the study was declared positive.

The research team is now expanding the cohort and launching a comprehensive translational research component. Tissue samples collected before treatment from prostate biopsies, along with posttreatment prostatectomy specimens from 14 patients, will undergo immunohistochemical analysis to evaluate PSMA expression. RNA sequencing studies are also planned to explore molecular changes associated with short-term darolutamide exposure.

Together, these efforts aim to better understand how androgen receptor inhibition affects PSMA imaging and disease detection in localized prostate cancer, potentially informing future imaging interpretation.

REFERENCE

Mota JM. A phase 2 trial of darolutamide to enhance prostate-specific membrane antigen expression in patients with localized prostate cancer (Daro-PET). Presented at: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium; February 26-28, 2026; San Francisco, CA. Abstract 310.