Dr Morgans on Previously Reported Data From the ARAMIS Trial in nmCRPC

Alicia Morgans, MD, MPH, genitourinary medical oncologist, medical director, Survivorship Program, Dana-Farber Cancer Institute, and associate professor of medicine, Harvard Medical School, discusses previously reported data from the phase 3 ARAMIS trial (NCT02200614), highlighting the rationale for conducting a follow-up analysis of the study in nonmetastatic castration-resistant prostate cancer (nmCRPC).

ARAMIS was an international registration trial that evaluated the combination of androgen deprivation therapy (ADT) and darolutamide (Nubeqa) in patients with nmCRPC, Morgans begins. All participants received ADT but continued to experience rising prostate-specific antigen (PSA) levels without radiographic evidence of metastatic disease on conventional CT and bone scans. To be eligible, patients also had to have high-risk nmCRPC, characterized by a PSA doubling time of 10 months or less, she reports.

The original findings from ARAMIS showed that adding darolutamide to ADT significantly improved metastasis-free survival (MFS) by 22 months compared with ADT plus placebo at a median follow-up of 17.9 months, Morgans explains. Additionally, improvement in overall survival with the combination ultimately led to the FDA approval of darolutamide in this setting, she emphasizes

A follow-up analysis using the data gathered from the ARAMIS trial was conducted to better understand disease progression and prognosis, Morgans continues. This analysis aimed to provide clinicians with more detailed insights into what to expect for each patient when treated with this combination. Researchers evaluated whether those who received intensified therapy with darolutamide experienced different, or potentially more difficult-to-detect, disease progression compared with those who received ADT plus placebo, she continues.

Another important goal was to determine whether achieving an undetectable PSA level, defined internationally as less than 0.2 ng/mL, was associated with longer disease control, Morgans states. This comparison aimed to better understand the clinical implications of PSA levels and their role in predicting treatment outcomes in patients with nmCRPC, she concludes.