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Phase 2 results from the US ARASEC trial, presented Friday during the plenary session of the American Urological Association (AUA) 2026 Annual Meeting and published the same week in The Journal of Urology, add new evidence supporting darolutamide (Nubeqa) combined with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC). In 320 US patients, the combination produced a 71% reduction in the risk of progression or death compared with a matched ADT-alone control from the historical CHAARTED trial (hazard ratio [HR] 0.29; 95% CI 0.20 to 0.40; P<.001).
ARASEC was designed to address a practical research problem. ADT monotherapy is no longer considered a defensible US control arm in mCSPC, so investigators prospectively enrolled patients to receive darolutamide 600 mg twice daily plus ADT and matched them one-to-one against CHAARTED ADT-alone patients using propensity scores based on age, ECOG performance status, disease extent, prior local therapy, Gleason score, and baseline PSA. Principal investigator Rana R. McKay, MD, presented the data.
Secondary endpoints favored the combination: overall survival (HR 0.50; 95% CI 0.30 to 0.82; P=.003), time to castration-resistant disease (HR 0.26), and radiological progression-free survival (HR 0.30) all reached statistical significance. PSA below 0.2 ng/mL at six months was achieved by 59% of the darolutamide arm versus 23% of the ADT-only group. Safety was consistent with prior darolutamide studies; 58% of treatment-emergent adverse events were grade 1 or 2, and 8% of patients discontinued because of them.
For managed care decision-makers, ARASEC adds a US-specific dataset to a treatment class already shaping mCSPC formulary positioning, while underscoring the limits of single-arm and externally controlled designs.
