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ARAMIS subgroup analysis: darolutamide benefits across PSADT groups

Prof. Martin Bögemann (University of Münster, Germany) presented a subgroup analysis of the ARAMIS trial (darolutamide vs placebo), which stratified patients into risk groups based on their prostate-specific antigen doubling time (PSADT), comparing safety and efficacy in patients with PSADTs of ≤6 months versus those with PSADTs >6-10 months [1,2]. Darolutamide demonstrated similar benefits in reducing metastases and death in both the PSADT ≤6 months and >6-10 months subgroups. The safety profile of the PSADT >6-10 months was similar to PSADT ≤6 months.

ARAMIS was a randomised, double-blind, placebo-controlled, phase 3 trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC) and a PSADT of ≤10 months. Participants (n=1,509) received darolutamide or placebo while continuing androgen-deprivation therapy. The primary endpoint of metastasis-free survival was met [2]; moreover, ...



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