Trial Information

Status:

Open

Specialty:

Prostate

Date Opened:

12-03-2026

Planned Close date:

31-12-2027

Sponsors:

Bayer AG

Site Recruitment:

6 /

36

Principal Investigator:

Dr Omi Parikh

Study Title:

ROAD: Real World Outcomes of Darolutamide, ADT ± Docetaxel

Contacts

Research Nurse / Study Coordinator:

Sarah Keith

Administrator:

Philippa Springle

Real-World Outcomes of Darolutamide, ADT, with or without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

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.

• INC1: Male patient with a diagnosis of mHSPC.
• INC2: Male aged ≥ 18 years (or country’s legal age of adulthood if the legal age is > 18 years).
• INC3: Histologically or cytologically confirmed adenocarcinoma of prostate. Participants may have begun ADT (up to 120 days prior to enrollment).
• INC4: Metastatic disease by conventional or new generation imaging.
• INC5: Decision to initiate treatment with darolutamide with, or without docetaxel was made as per investigator’s routine treatment practice prior to enrollment in the study.
• INC6: Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
• INC7: Life expectancy of ≥ 3 months based on clinical judgement.

• EXC1: Participation in an investigational program with interventions outside of routine clinical practice.
• EXC2: Contra-indications according to the local marketing authorization.
• EXC3: Any prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, or other investigational AR inhibitors, cytochrome P17 enzyme inhibitor such as abiraterone acetate or other investigational CYP 17 as antineoplastic treatment for prostate cancer.
• EXC4: Prior hormone therapy in the metastatic setting.
• EXC5: Treatment with darolutamide initiated more than 7 days prior to enrollment.