ROAD: Real World Outcomes of Darolutamide, ADT ± Docetaxel
Research type
Research Study
Full title
Real-World Outcomes of Darolutamide, ADT, with or without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
IRAS ID
365460
Contact name
Amit K Bahl
Contact email
Sponsor organisation
Bayer
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Prostate cancer is the second most common cancer and the fifth leading cause of cancer death among men worldwide, with an estimated 1,414,259 new cases and 375,304 deaths in 2020.
Previous standard treatment for patients with metastatic, hormone sensitive prostate cancer (mHSPC) includes the addition of either docetaxel or an androgen-receptor pathway inhibitor to androgen deprivation therapy (ADT)
Darolutamide has been evaluated in the phase 3 ARANOTE study, the combination of darolutamide and ADT (doublet) will be a new option for the management of patients with mHSPC. Consequently, the purpose of this observational study will be to describe the treatment outcomes of darolutamide (with docetaxel: triplet in the cohort 1 or without docetaxel: doublet in the cohort 2) in patients with mHSPC and also to describe their clinical and demographic characteristics with 2 cohorts.
As such this study will prospectively collect for the first time clinical and demographic data of patients treated with darolutamide triplet (cohort 1) and doublet (cohort 2) and will help to address these important clinical questions in the mHSPC setting in a descriptive manner in real life setting. The study findings may help guide clinicians in decision-making for the management of mHSPC patients in clinical practice, especially with the increasing use of darolutamide.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
25/WM/0246
Date of REC Opinion
27 Nov 2025
REC opinion
Further Information Favourable Opinion