An observational study in Metastatic Hormone-Sensitive Prostate Cancer, sponsored by Bayer. Active, not recruiting at 16 sites in 16 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Bayer · Observational
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.
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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.
Exclusion Criteria:
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) · Drug: ADT · Drug: Docetaxel
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) · Drug: ADT
Darolutamide administered per local standard of care in combination with ADT.
Also known as: NUBEQA
Androgen deprivation therapy administered per local standard of care.
Docetaxel administered per local standard of care in combination with darolutamide and ADT for cohort 1.
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.
Time 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.
Time frame: after 1 year of treatment
Overall survival per cohort and per country
Time from start of darolutamide treatment until death from any cause.
Time frame: up to 4 years
Overall survival per cohort in all countries
Time from start of darolutamide treatment until death from any cause.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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).
Time 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).
Time 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
Time 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
Time frame: 1 year
Survival rate per cohort and per country
Survival rate at specified time points.
Time frame: up to 4 years
Survival rate per cohort and all countries
Survival rate at specified time points.
Time frame: up to 4 years
Time to discontinuation per cohort and per country
Time from start of darolutamide treatment to permanent discontinuation or death
Time frame: up to 4 years
Time to discontinuation per cohort in all countries
Time from start of darolutamide treatment to permanent discontinuation or death
Time frame: up to 4 years
Reason for discontinuation percohort and per country
Reason for permanent darolutamide discontinuation
Time frame: up to 4 years
Reason for discontinuation per cohort in all countries
Reason for permanent darolutamide discontinuation
Time 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).
Time 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).
Time frame: at baseline
Medical History per cohort and per country
The medical history will be documented at study start.
Time frame: at baseline
Medical History per cohort in all countries
The medical history will be documented at study start.
Time frame: at baseline
Concomitant medication per cohort and per country
Documentation of Concomitant medication.
Time frame: up to 4 years
Concomitant medication per cohort in all countries
Documentation of Concomitant medication.
Time frame: up to 4 years
Concomitant treatment per cohort and per country
Documentation of Concomitant treatments.
Time frame: up to 4 years
Concomitant treatment per cohort in all countries
Documentation of Concomitant treatments.
Time frame: up to 4 years
Darolutamide use per cohort and per country
To describe real-world use of darolutamide in mHSPC patients.
Time frame: up to 4 years
Darolutamide use per cohort in all countries
To describe real-world use of darolutamide in mHSPC patients.
Time frame: up to 4 years
Diagnostic Imaging Technology per cohort and per country
Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
Time frame: at baseline
Diagnostic Imaging Technology per cohort in all countries
Documentation of Diagnostic Imaging Technology at the initial study visits (baseline).
Time frame: at baseline
Adverse events per cohort and per country
Number of all adverse events.
Time frame: up to 4 years
Adverse events per cohort in all countries
Number of all adverse events.
Time frame: up to 4 years
Serious Adverse events per cohort and per country
Number of all serious adverse events.
Time frame: up to 4 years
Serious Adverse events per cohort in all countries
Number of all serious adverse events.
Time frame: up to 4 years
Drug-related Adverse events per cohort and per country
Number of all drug-related (darolutamide) adverse events.
Time frame: up to 4 years
Drug-related Adverse events per cohort in all countries
Number of all drug-related (darolutamide) adverse events.
Time frame: up to 4 years
Serious Drug-related Adverse events per cohort and per country
Number of all serious drug-related (darolutamide) adverse events.
Time frame: up to 4 years
Serious Drug-related Adverse events per cohort in all countries
Number of all serious drug-related (darolutamide) adverse events.
Time frame: up to 4 years
Adverse events leading to treatment discontinuation per cohort and per country
Number of adverse events leading to treatment discontinuation.
Time frame: up to 4 years
Adverse events leading to treatment discontinuation per cohort in all countries
Number of adverse events leading to treatment discontinuation.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time 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.
Time frame: up to 4 years
Plan to share: 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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