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Eur Urol: Efficacy and safety assessment of Darolutamide in patients with non-metastatic prostate cancer

 Last Update: 2022-09-30
 Source: Internet
 Author: User

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Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) have a high risk of developing metastatic disease, especially when their prostate-specific antigen doubling time (PSADT) ≤ 6 months
.

Recently, researchers from Germany published an article in Eur Urol evaluating the efficacy and safety of darolutamide and placebo in patients stratified at PSADT>6 or ≤6 months
.

The researchers conducted a global multicenter, double-blind, randomized Phase 3 trial of men
with nmCRPC who had a PSADT ≤ for 10 months.

Of the 1509 enrolled patients, PSADT > 6 months (darolutamide, n=286; placebo, n=183) and 1040 people had PSADT ≤ 6 months (darululamide, n=669; placebo, n=371).

Curative effect of darolutamide in the PSADT subgroup

In summary, darolutamide provided a good benefit/risk ratio in patients with nmCRPC and PSADT greater than 6 months (up to 10 months), characterized by significant improvements in MFS, OS, and other clinically relevant endpoints, maintenance of QoL, and good
tolerability.

Original Source:

Martin Bögemann， Neal D Shore， Matthew R Smith et al.

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