Seminal Papers in Urology: Darolutamide and survival in metastatic, hormone-sensitive prostate cancer

TL;DR

A clinical trial found that adding darolutamide to standard treatments for prostate cancer improved patient survival without increasing side effects.

Contribution

The study demonstrates that triple therapy with darolutamide, ADT, and docetaxel significantly improves survival in metastatic prostate cancer.

Findings

Triple therapy improved overall survival with a hazard ratio of 0.68 compared to placebo.

The treatment had a similar side effect profile to the standard therapy without darolutamide.

The trial was assessed as having a low risk of bias.

Abstract

The ARASENS trial recruited 1306 men with metastatic hormone sensitive prostate cancer. It investigated the effect of androgen deprivation therapy (ADT) and systemic therapy docetaxel in combination with a third novel drug – daralutamide, compared with placebo on overall survival. Triple therapy with ADT, docetaxel and darolutamide resulted in improved overall survival rates as compared with ADT, docetaxel and placebo (HR 0.68; 95% CI, 0.57–0.80; p < 0.001). The side effect profile for both treatments was similar. This randomised, double blinded, placebo controlled study, was assessed to have a low risk of bias using the Cochrane Risk of Bias 2 tool.