Dr. Shore on the Design of the ARAMIS Trial With Darolutamide in nmCRPC

Neal D. Shore, MD, FACS, medical director of the Carolina Urologic Research Center, discusses the design of the phase 3 ARAMIS trial (NCT02200614) in nonmetastatic castration-resistant prostate cancer (nmCRPC).

ARAMIS was a global study that examined the safety and efficacy of darolutamide (Nubeqa) in the treatment of patients with nmCRPC, Shore says. At the time that the study was designed, no treatment options were approved for patients with nmCRPC who had rising levels of prostate-specific antigen (PSA), a castrate level of testosterone, and negative imaging on conventional CT and technetium bone scans, Shore explains.

Approximately 1500 patients were enrolled to the study. Participants were randomized 2:1 to receive either darolutamide or placebo, as well as continuous androgen deprivation therapy, Shore says.

The primary end point of the study was metastasis-free survival, and the primary analysis was considered to be successful, Shore concludes.