Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial

Future Oncol. 2022 Jul;18(21):2585-2597. doi: 10.2217/fon-2022-0433. Epub 2022 Jun 3.


What is this summary about?: This is a summary of a publication about the ARASENS trial, which was published in the New England Journal of Medicine in February 2022. The trial includes 1,306 men with a type of prostate cancer called metastatic, hormone-sensitive prostate cancer (also called mHSPC). In the trial, researchers wanted to learn if combining a treatment called darolutamide (also known by the brand name Nubeqa®) with two other medicines called androgen deprivation therapy (also called ADT) and docetaxel (brand name Taxotere®) could help treat patients with mHSPC better than placebo plus ADT and docetaxel. ADT with docetaxel is a treatment used for patients with mHSPC. Darolutamide is an approved treatment for a different type of prostate cancer called non-metastatic, castration-resistant prostate cancer (also called nmCRPC).

What were the results?: The trial results showed that combining darolutamide with ADT and docetaxel increased the chance of survival and lowered the risk of death by 32.5% compared to combining ADT and docetaxel with placebo instead. Compared to patients who received the placebo, patients who received darolutamide had a delay in: their cancer becoming castration-resistant worsening pain having cancer-related bone fractures or related symptoms needing additional therapies for cancer The percentage of trial patients who had medical problems during the trial, also called adverse events, was similar between trial patients who received darolutamide and those who received the placebo.

What do the results of the study mean?: Combining darolutamide with ADT and docetaxel helped treat trial patients with mHSPC better than placebo with ADT and docetaxel. Darolutamide in combination with ADT and docetaxel could be a treatment option for patients with mHSPC. Patients should always talk to their doctors and nurses before making any decisions about their treatment. This summary also includes perspectives on the ARASENS trial and prostate cancer from 3 members of the patient community. ClinicalTrials.gov NCT number: NCT02799602.

Keywords: Darolutamide; Drug development; Lay summary; Metastatic hormone-sensitive prostate cancer; Novel therapy; Overall survival; Plain language summary; Safety; Urological/prostate.

Publication types

  • Review
  • Comment

MeSH terms

  • Androgen Antagonists* / administration & dosage
  • Androgen Antagonists* / adverse effects
  • Caregivers
  • Docetaxel / therapeutic use
  • Hormones
  • Humans
  • Language
  • Male
  • Prostatic Neoplasms* / drug therapy
  • Prostatic Neoplasms* / pathology
  • Pyrazoles


  • Androgen Antagonists
  • Hormones
  • Pyrazoles
  • darolutamide
  • Docetaxel

Associated data

  • ClinicalTrials.gov/NCT02799602

Grant support