A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice (ROAD)

ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment. The primary objective is to estimate the proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (<0.2 ng/mL) at 1 year of treatment in each cohort. Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression. Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates. Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care. All patients must provide informed consent prior to participation. The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries. Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy. The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Hormone-Sensitive Prostate Cancer
• Intervention / Treatment: Drug: Darolutamide (BAY 1841788); Drug: ADT; Drug: Docetaxel

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Many locations
• Finland
  • Multiple Locations, Finland
    • Many locations
• France
  • Multiple Locations, France
    • Many locations
• Germany
  • Multiple Locations, Germany
    • Many locations
• Greece
  • Multiple Locations, Greece
    • Many locations
• Israel
  • Multiple Locations, Israel
    • Many locations
• Italy
  • Multiple Locations, Italy
    • Many locations
• Lithuania
  • Multiple Locations, Lithuania
    • Many locations
• Norway
  • Multiple Locations, Norway
    • Many locations
• Poland
  • Multiple Locations, Poland
    • Many locations
• Portugal
  • Multiple Locations, Portugal
    • Many locations
• Saudi Arabia
  • Multiple Locations, Saudi Arabia
    • Many locations
• Spain
  • Multiple Locations, Spain
    • Many locations
• Sweden
  • Multiple Locations, Sweden
    • Many locations
• Switzerland
  • Multiple Locations, Switzerland
    • Many locations
• United Kingdom
  • Multiple Locations, United Kingdom
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients with a diagnosis of metastatic hormone-sensitive prostate cancer (mHSPC) for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment.

Description

Inclusion Criteria:

• Male patient with a diagnosis of mHSPC
• Male aged ≥18 years (or country's legal age of adulthood if >18 years)
• Histologically or cytologically confirmed adenocarcinoma of prostate; may have begun ADT (up to 120 days prior to enrollment)
• Metastatic disease by conventional or new generation imaging
• Decision to initiate treatment with darolutamide with or without docetaxel made prior to enrollment
• Signed informed patient consent before start of data collection
• Life expectancy of ≥3 months based on clinical judgment

Exclusion Criteria:

• Participation in an investigational program with interventions outside of routine clinical practice
• Contraindications according to local marketing authorization
• Any prior treatment with second-generation AR inhibitors (enzalutamide, apalutamide, or investigational AR inhibitors), CYP17 inhibitors (abiraterone acetate or investigational CYP17 inhibitors) as antineoplastic treatment for prostate cancer
• Prior hormone therapy in the metastatic setting
• Treatment with darolutamide initiated more than 7 days prior to enrollment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Darolutamide + ADT + Docetaxel (Triplet therapy); This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The decision to use this triplet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive all three treatments according to local standard of care.	Drug: Darolutamide (BAY 1841788); Darolutamide administered per local standard of care in combination with ADT.; Other Names: NUBEQA; Drug: ADT; Androgen deprivation therapy administered per local standard of care.; Drug: Docetaxel; Docetaxel administered per local standard of care in combination with darolutamide and ADT for cohort 1.
Darolutamide + ADT (Doublet therapy); This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with darolutamide and androgen deprivation therapy (ADT), but without docetaxel. The decision to use this doublet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive darolutamide and ADT according to local standard of care.	Drug: Darolutamide (BAY 1841788); Darolutamide administered per local standard of care in combination with ADT.; Other Names: NUBEQA; Drug: ADT; Androgen deprivation therapy administered per local standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year	To describe the effectiveness of darolutamide + ADT + docetaxel in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA<0.2 ng/mL) after 1 year of study treatment.	after 1 year of treatment
Proportion of patients in cohort 2 achieving undetectable PSA (<0.2 ng/mL) at 1 year	To describe the effectiveness of darolutamide + ADT in patients with mHSPC by means of estimating the prostate-specific antigen (PSA) undetectable rates (PSA<0.2 ng/mL) after 1 year of study treatment.	after 1 year of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival per cohort and per country	Time from start of darolutamide treatment until death from any cause.	up to 4 years
Overall survival per cohort in all countries	Time from start of darolutamide treatment until death from any cause.	up to 4 years
Time to subsequent treatment per cohort and per country	Time from start of darolutamide treatment to initiation of a new anti-cancer therapy.	up to 4 years
Time to subsequent treatment per cohort in all countries	Time from start of darolutamide treatment to initiation of a new anti-cancer therapy.	up to 4 years
Time to castration resistance (CRPC) per cohort and per country	Time from enrollment until documented clinical or PSA progression with testosterone level <50 ng/dL or documented medical/surgical castration.	up to 4 years
Time to castration resistance (CRPC) per cohort in all countries	Time from enrollment until documented clinical or PSA progression with testosterone level <50 ng/dL or documented medical/surgical castration.	up to 4 years
Time to PSA progression per cohort and per country	Time from start of darolutamide treatment to PSA progression (≥25% increase above nadir and ≥2 ng/mL, confirmed by a second value ≥3 weeks later, but prior to 6 months, while on treatment).	up to 4 years
Time to PSA progression per cohort in all countries	Time from start of darolutamide treatment to PSA progression (≥25% increase above nadir and ≥2 ng/mL, confirmed by a second value ≥3 weeks later, but prior to 6 months, while on treatment).	up to 4 years
PSA response rate per cohort and per country	Proportion of patients with blood PSA level <0.2 ng/mL, confirmed by a second subsequent PSA value <0.2 ng/mL 3 or more weeks later	1 year
PSA response rate per cohort in all countries	Proportion of patients with blood PSA level <0.2 ng/mL, confirmed by a second subsequent PSA value <0.2 ng/mL 3 or more weeks later	1 year
Survival rate per cohort and per country	Survival rate at specified time points.	up to 4 years
Survival rate per cohort and all countries	Survival rate at specified time points.	up to 4 years
Time to discontinuation per cohort and per country	Time from start of darolutamide treatment to permanent discontinuation or death	up to 4 years
Time to discontinuation per cohort in all countries	Time from start of darolutamide treatment to permanent discontinuation or death	up to 4 years
Reason for discontinuation percohort and per country	Reason for permanent darolutamide discontinuation	up to 4 years
Reason for discontinuation per cohort in all countries	Reason for permanent darolutamide discontinuation	up to 4 years
Patient demographics per cohort and per country	Demographic characteristics at the first documented regular visit ion the study, referred to as baseline).	at baseline
Patient demographics per cohort in all countries	Demographic characteristics at the first documented regular visit ion the study, referred to as baseline).	at baseline
Medical History per cohort and per country	The medical history will be documented at study start.	at baseline
Medical History per cohort in all countries	The medical history will be documented at study start.	at baseline
Concomitant medication per cohort and per country	Documentation of Concomitant medication.	up to 4 years
Concomitant medication per cohort in all countries	Documentation of Concomitant medication.	up to 4 years
Concomitant treatment per cohort and per country	Documentation of Concomitant treatments.	up to 4 years
Concomitant treatment per cohort in all countries	Documentation of Concomitant treatments.	up to 4 years
Darolutamide use per cohort and per country	To describe real-world use of darolutamide in mHSPC patients.	up to 4 years
Darolutamide use per cohort in all countries	To describe real-world use of darolutamide in mHSPC patients.	up to 4 years
Diagnostic Imaging Technology per cohort and per country	Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).	at baseline
Diagnostic Imaging Technology per cohort in all countries	Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).	at baseline
Adverse events per cohort and per country	Number of all adverse events.	up to 4 years
Adverse events per cohort in all countries	Number of all adverse events.	up to 4 years
Serious Adverse events per cohort and per country	Number of all serious adverse events.	up to 4 years
Serious Adverse events per cohort in all countries	Number of all serious adverse events.	up to 4 years
Drug-related Adverse events per cohort and per country	Number of all drug-related (darolutamide) adverse events.	up to 4 years
Drug-related Adverse events per cohort in all countries	Number of all drug-related (darolutamide) adverse events.	up to 4 years
Serious Drug-related Adverse events per cohort and per country	Number of all serious drug-related (darolutamide) adverse events.	up to 4 years
Serious Drug-related Adverse events per cohort in all countries	Number of all serious drug-related (darolutamide) adverse events.	up to 4 years
Adverse events leading to treatment discontinuation per cohort and per country	Number of adverse events leading to treatment discontinuation.	up to 4 years
Adverse events leading to treatment discontinuation per cohort in all countries	Number of adverse events leading to treatment discontinuation.	up to 4 years
Vital Signs: Blood Pressure per cohort and per country	Blood Pressure is measured in mmHg throughout the study, at all major visit types, over the full observation period.	up to 4 years
Vital Signs: Blood Pressure per cohort in all countries	Blood Pressure is measured in mmHg throughout the study, at all major visit types, over the full observation period.	up to 4 years
Vital Signs: Body Temperature per cohort and per country	Body Temperature is measured in degrees Celsius (°C) or Fahrenheit (°F) (as per local practice) throughout the study, at all major visit types, over the full observation period.	up to 4 years
Vital Signs: Body Temperature per cohort in all countries	Body Temperature is measured in degrees Celsius (°C) or Fahrenheit (°F) (as per local practice) throughout the study, at all major visit types, over the full observation period.	up to 4 years
Vital Signs: Weight per cohort and per country	Weight is measured in kilograms (kg) throughout the study, at all major visit types, over the full observation period.	up to 4 years
Vital Signs: Weight per cohort in all countries	Weight is measured in kilograms (kg) throughout the study, at all major visit types, over the full observation period.	up to 4 years
Vital Signs: Height per cohort and per country	Height is measured in centimeters (cm) throughout the study, at all major visit types, over the full observation period.	up to 4 years
Vital Signs: Height per cohort in all countries	Height is measured in centimeters (cm) throughout the study, at all major visit types, over the full observation period.	up to 4 years
Laboratory Parameters: Hematology (Hemoglobin) per cohort and per country	Hemoglobin (g/dL)) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Hematology (Hemoglobin) per cohort in all countries	Hemoglobin (g/dL)) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Hematology (WBC) per cohort and per country	White Blood Cell Count (WBC) (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Hematology (WBC) per cohort in all countries	White Blood Cell Count (WBC) (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Hematology (Platelet Count) per cohort and per country	Platelet Count (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Hematology (Platelet Count) per cohort in all countries	Platelet Count (x10^9/L) is performed throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (Creatinine) per cohort and per country	Serum Creatinine (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (Creatinine) per cohort in all countries	Serum Creatinine (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (ALT) per cohort and per country	Alanine Aminotransferase (ALT) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (ALT) per cohort in all countries	Alanine Aminotransferase (ALT) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (AST) per cohort and per country	Aspartate Aminotransferase (AST) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (AST) per cohort in all countries	Aspartate Aminotransferase (AST) (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (Bilirubin) per cohort and per country	Total Bilirubin (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (Bilirubin) per cohort in all countries	Total Bilirubin (mg/dL or µmol/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (Alkaline Phosphatase) per cohort and per country	Alkaline Phosphatase (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (Alkaline Phosphatase) per cohort in all countries	Alkaline Phosphatase (U/L) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (PSA) per cohort and per country	Prostate-Specific Antigen (PSA) (ng/mL) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years
Laboratory Parameters: Clinical Chemistry (PSA) per cohort in all countries	Prostate-Specific Antigen (PSA) (ng/mL) is determined throughout the study, at all major visit types, for the duration of darolutamide treatment and as needed during follow-up, up to the end of observation.	up to 4 years

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Prostatic Neoplasms, Hormone-Sensitive/Metastatic Prostate Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; darolutamide
• Other Study ID Numbers: 23100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No