ARASEC: Clinical Implications and the Role of Multidisciplinary Care

With the phase 2 ARASEC (NCT02799602) results establishing an rPFS and overall survival benefit for darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC), Neal D. Shore, MD, FACS, and Rana R. McKay, MD, FASCO, turned to the practical implications of these findings for clinicians managing patients across the disease spectrum. The conversation addressed how darolutamide fits within a therapeutic landscape now populated by proven doublet and triplet regimens, and why the ARASEC data add meaningful specificity for US practitioners.

McKay noted that safety data from ARASEC were benchmarked against the ADT monotherapy arm of ARANOTE (NCT04736199), given that CHAARTED (NCT02799602) did not collect safety data from its control arm. The safety profile of darolutamide plus ADT was largely consistent with ADT monotherapy, reflecting darolutamide's known pharmacologic properties, including limited central nervous system penetration, which is associated with a reduced risk of cognitive adverse effects. McKay referenced forthcoming ECOG data comparing cognitive effects of darolutamide and enzalutamide (Xtandi), anticipating that these data will further differentiate agents within the ARPI class and support shared clinical decision-making.

Shore and McKay emphasized that prostate cancer management in the mHSPC setting is now inherently multidisciplinary, with urologists, medical oncologists, and radiation oncologists each playing a role in initiating and coordinating therapy. McKay—who holds appointments in medicine, urology, and radiation oncology at the University of California, San Diego—underscored that patients seen initially by a urologist can appropriately begin darolutamide and ADT, with input from other specialists as needed. Shore noted that the ARASEC data, combined with the expanded FDA label for darolutamide in mHSPC without chemotherapy, now provide US physicians a well-characterized doublet option supported by prospective data across both high- and low-volume disease.