Clinical use and outcomes of androgen-receptor pathway inhibitors triplet therapy for metastatic hormone-sensitive prostate cancer (ARAAT)

This retrospective cohort analysis used the ConcertAI Patient360 database, a geographically diverse US oncology electronic medical record source. Adult patients with mHSPC who initiated triplet therapy with darolutamide+ADT+DOC (DAR) or abiraterone+ADT+DOC (ABI) from 1/2020–1/2024 were included. Outcomes included the proportion of patients achieving prostate-specific antigen (PSA) response (≥90% decline or undetectable levels <0.2 ng/mL), treatment discontinuation, progression to metastatic castration-resistant prostate cancer (mCRPC), and OS. PSA response during index treatment is reported at 6 and 12 months. Kaplan–Meier (K–M) estimated probability for discontinuation and progression to mCRPC are reported at 18 months.

A total of 243 patients initiated DAR (n=141) and ABI (n=102) for mHSPC. The median age was 66 years; 80% had an Eastern Cooperative Oncology Group performance status score of 0/1; and >80% completed ≥6 DOC cycles. The median baseline PSA was 36 ng/mL for DAR vs 20 ng/mL for ABI. Median follow-up duration was 16 months for the DAR cohort and 19 months for the ABI cohort. More patients in the DAR cohort achieved a PSA response at 6 and 12 months compared with those in the ABI cohort (Table). At 18 months, K–M probability of discontinuation was 25% for DAR vs 38% for ABI, and probability of progression to mCRPC was 24% for DAR vs 46% for ABI (Table). At the end of the follow-up period, 91% of patients in the DAR cohort were alive compared with 78% in the ABI cohort.

Using a real-world dataset, treatment discontinuation rates, progression to mCRPC, and PSA responses were all favorable in patients with mHSPC receiving triplet therapy with DAR vs ABI. Further investigation is warranted.