The Phase 3 ARANOTE trial has revealed that the combination of darolutamide (Nubeqa) and androgen-deprivation therapy (ADT) significantly lowers the risk of radiological progression or death in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study's findings, presented at the 2024 European Society for Medical Oncology Annual Congress, suggest a potential new standard of care for mHSPC.
Key Findings from ARANOTE
The ARANOTE trial (NCT04736199) evaluated the efficacy and safety of darolutamide plus ADT in men with mHSPC. The results indicated a notable reduction in the risk of radiological progression or death with the combination therapy. Dr. Fred Saad, Director of Prostate Cancer Research at the Montreal Cancer Institute/University of Montreal Hospital Center (CHUM) Research Center (CRCHUM), highlighted the potential clinical implications of these findings.
Clinical Implications and Future Directions
Dr. Saad emphasized that darolutamide plus ADT could become a standard of care, offering another therapeutic option alongside existing androgen receptor pathway inhibitors (ARPIs). This allows for tailoring treatments based on individual patient needs and profiles. The availability of docetaxel in combination regimens further expands treatment possibilities, enabling clinicians to consider ADT plus darolutamide with or without docetaxel.
Future research will explore darolutamide's efficacy in earlier stages of prostate cancer, including non-metastatic and hormone-sensitive settings. Dr. Saad noted the drug's favorable safety profile and minimal drug-drug interactions, making it an attractive candidate for combination therapies. These ongoing trials aim to optimize treatment strategies and improve outcomes for patients across different stages of prostate cancer.
