pause_circle_filledNot Yet Recruiting

Metastatic Hormone-Sensitive Prostate Cancer

Bayer Identifier:
23100
ClinicalTrials.gov Identifier:
NCT07344779
EudraCT Number:
Not Available
EU CT Number:
Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
    - 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
    - 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

Trial summary

Enrollment Goal
1600
Trial Dates
January 2026 - June 2030
Phase
N/A
Could I Receive a placebo
No
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Many LocationsMany Locations, Spain

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    after 1 year of treatment

Secondary Outcome

  • Overall survival per cohort and per country
    Time from start of darolutamide treatment until death from any cause.
    date_rangeTime Frame:
    up to 4 years
  • Overall survival per cohort in all countries
    Time from start of darolutamide treatment until death from any cause.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    1 year
  • Survival rate per cohort and per country
    Survival rate at specified time points.
    date_rangeTime Frame:
    up to 4 years
  • Survival rate per cohort and all countries
    Survival rate at specified time points.
    date_rangeTime Frame:
    up to 4 years
  • Time to discontinuation per cohort and per country
    Time from start of darolutamide treatment to permanent discontinuation or death
    date_rangeTime Frame:
    up to 4 years
  • Time to discontinuation per cohort in all countries
    Time from start of darolutamide treatment to permanent discontinuation or death
    date_rangeTime Frame:
    up to 4 years
  • Reason for discontinuation percohort and per country
    Reason for permanent darolutamide discontinuation
    date_rangeTime Frame:
    up to 4 years
  • Reason for discontinuation per cohort in all countries
    Reason for permanent darolutamide discontinuation
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    at baseline
  • Patient demographics per cohort in all countries
    Demographic characteristics at the first documented regular visit ion the study, referred to as baseline).
    date_rangeTime Frame:
    at baseline
  • Medical History per cohort and per country
    The medical history will be documented at study start.
    date_rangeTime Frame:
    at baseline
  • Medical History per cohort in all countries
    The medical history will be documented at study start.
    date_rangeTime Frame:
    at baseline
  • Concomitant medication per cohort and per country
    Documentation of Concomitant medication.
    date_rangeTime Frame:
    up to 4 years
  • Concomitant medication per cohort in all countries
    Documentation of Concomitant medication.
    date_rangeTime Frame:
    up to 4 years
  • Concomitant treatment per cohort and per country
    Documentation of Concomitant treatments.
    date_rangeTime Frame:
    up to 4 years
  • Concomitant treatment per cohort in all countries
    Documentation of Concomitant treatments.
    date_rangeTime Frame:
    up to 4 years
  • Darolutamide use per cohort and per country
    To describe real-world use of darolutamide in mHSPC patients.
    date_rangeTime Frame:
    up to 4 years
  • Darolutamide use per cohort in all countries
    To describe real-world use of darolutamide in mHSPC patients.
    date_rangeTime Frame:
    up to 4 years
  • Diagnostic Imaging Technology per cohort and per country
    Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
    date_rangeTime Frame:
    at baseline
  • Diagnostic Imaging Technology per cohort in all countries
    Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
    date_rangeTime Frame:
    at baseline
  • Adverse events per cohort and per country
    Number of all adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Adverse events per cohort in all countries
    Number of all adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Serious Adverse events per cohort and per country
    Number of all serious adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Serious Adverse events per cohort in all countries
    Number of all serious adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Drug-related Adverse events per cohort and per country
    Number of all drug-related (darolutamide) adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Drug-related Adverse events per cohort in all countries
    Number of all drug-related (darolutamide) adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Serious Drug-related Adverse events per cohort and per country
    Number of all serious drug-related (darolutamide) adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Serious Drug-related Adverse events per cohort in all countries
    Number of all serious drug-related (darolutamide) adverse events.
    date_rangeTime Frame:
    up to 4 years
  • Adverse events leading to treatment discontinuation per cohort and per country
    Number of adverse events leading to treatment discontinuation.
    date_rangeTime Frame:
    up to 4 years
  • Adverse events leading to treatment discontinuation per cohort in all countries
    Number of adverse events leading to treatment discontinuation.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    up to 4 years

Trial design

ROAD – Real-World Outcomes of Darolutamide, ADT, with or without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information