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Novo Nordisk 20 March 2024, 11:21
Carterra – 24th March 2025

Data day: Trial results deliver hope for prostate cancer patients

New combination treatment can significantly reduce the risk of death among prostate cancer patients

A pivotal Phase 3 trial has shown that a new combination treatment can significantly reduce the risk of death among prostate cancer patients by almost 33%.

Results from the Phase 3 ARASENS clinical trial have shown that the use of the oral androgen receptor inhibitor (ARi) darolutamide, with ADT and docetaxel, significantly reduced the risk of death by 32.5%, compared to docetaxel plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

mHSPC refers to when cancer has spread past the prostate into the body, but can be treated with hormone therapy.

“Despite existing effective treatments, many men with metastatic hormone-sensitive prostate cancer (mHSPC) will unfortunately progress to metastatic castration-resistant prostate cancer (mCRPC) within 2-3 years, when treatment options become more limited,” explained Professor Alison Birtle, Consultant Clinical Oncologist at Lancashire Teaching Hospitals NHS Foundation Trust.

In the ARASENS trial, darolutamide plus ADT and docetaxel showed significant increase in overall survival, and decrease in disease progression, in patients with mHSPC. Treatment with darolutamide also showed consistent improvements in key secondary endpoints, including delaying the time to castration-resistance prostate cancer (CRPC) by 64.3% compared to the placebo arm

“The exciting results from the ARASENS study show that darolutamide given with two other standard treatments for newly diagnosed metastatic prostate cancer can make men live longer and have a good quality of life,” Professor Alison Birtle added. “We need more treatments like darolutamide and I hope the novel combination of these three treatments will soon be available on the NHS for men with mHSPC in the UK.”

Dr Matthew Hobbs, Director of Research at Prostate Cancer UK, concluded: “Treatment for advanced prostate cancer that is still responding to hormone therapy has improved rapidly in the past six years. The results of the ARASENS study show that adding darolutamide to androgen deprivation therapy and docetaxel could give men with advanced prostate cancer even longer life expectancy.”

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