# 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.

## Key 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.