Metastatic Hormone-Sensitive Prostate CancerROADNCT07344779
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
An observational study of Metastatic Hormone-Sensitive Prostate Cancer, run by Bayer at 16 sites in 16 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer
- What is being tested?
- Darolutamide (BAY 1841788), ADT and Docetaxel
- How many people
- 1,600 participants
- Where
- 16 sitesin 16 countries
- Study dates
- 29 Jan 2026to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to local marketing authorization
- Any prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, or other investigational AR inhibitors, cytochrome P17 enzyme inhibitor (except prior abiraterone acetate if discontinued at least 24 months before metastatic diagnosis) or other investigational CYP 17 enzyme 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
Trial locations and contacts
16 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 16 countries
Lithuania1 site, 1 recruiting
- Not yet recruiting
Many Locations
Many Locations
Saudi Arabia1 site, 1 recruiting
- Not yet recruiting
Many Locations
Many Locations
United Kingdom1 site, 1 recruiting
- Recruiting
Many Locations
Many Locations
About this study
Official title: 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.
- Being tested
- Darolutamide (BAY 1841788), ADT, Docetaxel
- Keywords
- Prostatic Neoplasms, Hormone-Sensitive/Metastatic Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide (BAY 1841788)Drug
Also called NUBEQA
Darolutamide administered per local standard of care in combination with ADT.
ADTDrug
Androgen deprivation therapy administered per local standard of care.
DocetaxelDrug
Docetaxel administered per local standard of care in combination with darolutamide and ADT for cohort 1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Darolutamide (BAY 1841788); Drug: ADT; Drug: Docetaxel | |
| 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. Receives: Drug: Darolutamide (BAY 1841788); Drug: ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 1 year of treatment
Secondary outcomes (64)
Overall survival per cohort and per country
Time from start of darolutamide treatment until death from any cause.
Measured: up to 4 years
Overall survival per cohort in all countries
Time from start of darolutamide treatment until death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 1 year
Survival rate per cohort and per country
Survival rate at specified time points.
Measured: up to 4 years
Survival rate per cohort and all countries
Survival rate at specified time points.
Measured: up to 4 years
Time to discontinuation per cohort and per country
Time from start of darolutamide treatment to permanent discontinuation or death
Measured: up to 4 years
Time to discontinuation per cohort in all countries
Time from start of darolutamide treatment to permanent discontinuation or death
Measured: up to 4 years
Reason for discontinuation percohort and per country
Reason for permanent darolutamide discontinuation
Measured: up to 4 years
Reason for discontinuation per cohort in all countries
Reason for permanent darolutamide discontinuation
Measured: 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).
Measured: at baseline
Patient demographics per cohort in all countries
Demographic characteristics at the first documented regular visit ion the study, referred to as baseline).
Measured: at baseline
Medical History per cohort and per country
The medical history will be documented at study start.
Measured: at baseline
Medical History per cohort in all countries
The medical history will be documented at study start.
Measured: at baseline
Concomitant medication per cohort and per country
Documentation of Concomitant medication.
Measured: up to 4 years
Concomitant medication per cohort in all countries
Documentation of Concomitant medication.
Measured: up to 4 years
Concomitant treatment per cohort and per country
Documentation of Concomitant treatments.
Measured: up to 4 years
Concomitant treatment per cohort in all countries
Documentation of Concomitant treatments.
Measured: up to 4 years
Darolutamide use per cohort and per country
To describe real-world use of darolutamide in mHSPC patients.
Measured: up to 4 years
Darolutamide use per cohort in all countries
To describe real-world use of darolutamide in mHSPC patients.
Measured: up to 4 years
Diagnostic Imaging Technology per cohort and per country
Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
Measured: at baseline
Diagnostic Imaging Technology per cohort in all countries
Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
Measured: at baseline
Adverse events per cohort and per country
Number of all adverse events.
Measured: up to 4 years
Adverse events per cohort in all countries
Number of all adverse events.
Measured: up to 4 years
Serious Adverse events per cohort and per country
Number of all serious adverse events.
Measured: up to 4 years
Serious Adverse events per cohort in all countries
Number of all serious adverse events.
Measured: up to 4 years
Drug-related Adverse events per cohort and per country
Number of all drug-related (darolutamide) adverse events.
Measured: up to 4 years
Drug-related Adverse events per cohort in all countries
Number of all drug-related (darolutamide) adverse events.
Measured: up to 4 years
Serious Drug-related Adverse events per cohort and per country
Number of all serious drug-related (darolutamide) adverse events.
Measured: up to 4 years
Serious Drug-related Adverse events per cohort in all countries
Number of all serious drug-related (darolutamide) adverse events.
Measured: up to 4 years
Adverse events leading to treatment discontinuation per cohort and per country
Number of adverse events leading to treatment discontinuation.
Measured: up to 4 years
Adverse events leading to treatment discontinuation per cohort in all countries
Number of adverse events leading to treatment discontinuation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start29 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344779
- Sponsor's protocol ID
- 23100
- Acronym
- ROAD
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07344779
- Acronym / sponsor ID
- ROAD / 23100
- Keywords
- Prostatic Neoplasms, Hormone-Sensitive/Metastatic Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darolutamide + ADT + Docetaxel (Triplet therapy) | – | Drug: Darolutamide (BAY 1841788), Drug: ADT, Drug: DocetaxelThis 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. |
| Darolutamide + ADT (Doublet therapy) | – | Drug: Darolutamide (BAY 1841788), Drug: ADTThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to local marketing authorization
- Any prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, or other investigational AR inhibitors, cytochrome P17 enzyme inhibitor (except prior abiraterone acetate if discontinued at least 24 months before metastatic diagnosis) or other investigational CYP 17 enzyme 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darolutamide (BAY 1841788)Also: NUBEQADarolutamide administered per local standard of care in combination with ADT. | Drug | Darolutamide + ADT (Doublet therapy), Darolutamide + ADT + Docetaxel (Triplet therapy) |
| ADTAndrogen deprivation therapy administered per local standard of care. | Drug | Darolutamide + ADT (Doublet therapy), Darolutamide + ADT + Docetaxel (Triplet therapy) |
| DocetaxelDocetaxel administered per local standard of care in combination with darolutamide and ADT for cohort 1. | Drug | Darolutamide + ADT + Docetaxel (Triplet therapy) |
Primary outcome
Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year
Time frame: after 1 year of treatment
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.
Proportion of patients in cohort 2 achieving undetectable PSA (<0.2 ng/mL) at 1 year
Time frame: after 1 year of treatment
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.
64 secondary outcomes
Overall survival per cohort and per country
Time frame: up to 4 years
Overall survival per cohort in all countries
Time frame: up to 4 years
Time to subsequent treatment per cohort and per country
Time frame: up to 4 years
Time to subsequent treatment per cohort in all countries
Time frame: up to 4 years
Time to castration resistance (CRPC) per cohort and per country
Time frame: up to 4 years
Time to castration resistance (CRPC) per cohort in all countries
Time frame: up to 4 years
Time to PSA progression per cohort and per country
Time frame: up to 4 years
Time to PSA progression per cohort in all countries
Time frame: up to 4 years
PSA response rate per cohort and per country
Time frame: 1 year
PSA response rate per cohort in all countries
Time frame: 1 year
Survival rate per cohort and per country
Time frame: up to 4 years
Survival rate per cohort and all countries
Time frame: up to 4 years
Time to discontinuation per cohort and per country
Time frame: up to 4 years
Time to discontinuation per cohort in all countries
Time frame: up to 4 years
Reason for discontinuation percohort and per country
Time frame: up to 4 years
Reason for discontinuation per cohort in all countries
Time frame: up to 4 years
Patient demographics per cohort and per country
Time frame: at baseline
Patient demographics per cohort in all countries
Time frame: at baseline
Medical History per cohort and per country
Time frame: at baseline
Medical History per cohort in all countries
Time frame: at baseline
Concomitant medication per cohort and per country
Time frame: up to 4 years
Concomitant medication per cohort in all countries
Time frame: up to 4 years
Concomitant treatment per cohort and per country
Time frame: up to 4 years
Concomitant treatment per cohort in all countries
Time frame: up to 4 years
Darolutamide use per cohort and per country
Time frame: up to 4 years
Darolutamide use per cohort in all countries
Time frame: up to 4 years
Diagnostic Imaging Technology per cohort and per country
Time frame: at baseline
Diagnostic Imaging Technology per cohort in all countries
Time frame: at baseline
Adverse events per cohort and per country
Time frame: up to 4 years
Adverse events per cohort in all countries
Time frame: up to 4 years
Serious Adverse events per cohort and per country
Time frame: up to 4 years
Serious Adverse events per cohort in all countries
Time frame: up to 4 years
Drug-related Adverse events per cohort and per country
Time frame: up to 4 years
Drug-related Adverse events per cohort in all countries
Time frame: up to 4 years
Serious Drug-related Adverse events per cohort and per country
Time frame: up to 4 years
Serious Drug-related Adverse events per cohort in all countries
Time frame: up to 4 years
Adverse events leading to treatment discontinuation per cohort and per country
Time frame: up to 4 years
Adverse events leading to treatment discontinuation per cohort in all countries
Time frame: up to 4 years
Vital Signs: Blood Pressure per cohort and per country
Time frame: up to 4 years
Vital Signs: Blood Pressure per cohort in all countries
Time frame: up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Hormone-Sensitive Prostate Cancer, run by Bayer at 16 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Belgium, Finland, France, Germany, Greece and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in cohort 1 achieving undetectable PSA (<0.2 ng/mL) at 1 year (time frame: after 1 year of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.