A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics (Double-DARE)

April 8, 2026 updated by: Bayer

Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA

Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a "triplet" combination with ADT and docetaxel. It is also used in a "doublet" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44114-2619
        • Recruiting
        • Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult men with de novo metastatic hormone-sensitive prostate cancer initiating androgen receptor pathway inhibitor therapy in US community urology clinics

Description

Inclusion Criteria:

  • Male patients with evidence of de novo mHSPC during the study period
  • Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis
  • Age ≥18 years at index date (ARPI initiation for mHSPC)
  • Initiation of ADT and/or docetaxel therapy within ±90 days from index date
  • At least 90 days of EMR activity prior to the index date
  • At least 90 days of EMR activity post-index, unless the patient died earlier.

Exclusion Criteria:

  • History of other primary cancers (except non-melanoma skin cancer)
  • Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date
  • Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis
  • Clinical trial participation during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Darolutamide + ADT + docetaxel
Patients receiving darolutamide in combination with androgen deprivation therapy with docetaxel
Drug: Darolutamide
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Other Names:
  • Nubeqa
Abiraterone acetate + ADT + docetaxel
Patients receiving abiraterone acetate in combination with androgen deprivation therapy with docetaxel
Drug: Abiraterone acetate
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Enzalutamide + ADT
Patients receiving enzalutamide in combination with androgen deprivation therapy
Drug: Enzalutamide
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Apalutamide + ADT
Patients receiving apalutamide in combination with androgen deprivation therapy
Drug: Apalutamide
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Darolutamide + ADT
Patients receiving darolutamide in combination with androgen deprivation therapy
Drug: Darolutamide
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Other Names:
  • Nubeqa
Abiraterone acetate + ADT
Patients receiving abiraterone acetate in combination with androgen deprivation therapy
Drug: Abiraterone acetate
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age
Time Frame: Baseline
Age will be documented in years to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): age
Time Frame: Baseline
Age will be documented in years to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Concomitant Medication
Time Frame: Baseline
Number of concomitant medication will be recorded to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Concomitant Medication
Time Frame: Baseline
Number of concomitant medication will be recorded to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): ethnicity
Time Frame: Baseline
Ethnicity will be documented to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): ethnicity
Time Frame: Baseline
Ethnicity will be documented to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Charlson Comorbidity Index
Time Frame: Baseline
The Charlson Comorbidity Index (CCI) (ranging 0 (no comorbid coonditions) to 5 (high comorbidity burden)) will be determined to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Charlson Comorbidity Index
Time Frame: Baseline
The Charlson Comorbidity Index (CCI) (ranging 0 (no comorbid coonditions) to 5 (high comorbidity burden)) will be determined to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Gleason Score
Time Frame: Baseline
The Gleason Score (primary and secondary cancer cell pattern are graded on a scale from 1 (least aggressive) to 5 (most aggressive)) will be determined to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Gleason Score
Time Frame: Baseline
The Gleason Score (primary and secondary cancer cell pattern are graded on a scale from 1 (least aggressive) to 5 (most aggressive)) will be determined to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): PSA
Time Frame: Baseline
Most recent prostate specific antigen (PSA) value will be recorded to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): PSA
Time Frame: Baseline
Most recent prostate specific antigen (PSA) value will be recorded to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): de novo mHSPC Diagnosis
Time Frame: Baseline
Record of time from de novo mHSPC diagnosis to Index Date to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): de novo mHSPC Diagnosis
Time Frame: Baseline
Record of time from de novo mHSPC diagnosis to Index Date to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Baseline
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: initial dose
Time Frame: Day 1 - recorded on the index date (date of first evidence of darolutamide initiation/prescription).
Document initial dose. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Day 1 - recorded on the index date (date of first evidence of darolutamide initiation/prescription).
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: initial dose
Time Frame: Day 1 - recorded on the index date (date of first evidence of darolutamide initiation/prescription).
Document initial dose. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
Day 1 - recorded on the index date (date of first evidence of darolutamide initiation/prescription).
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: dose change
Time Frame: From index date (Day 1) until the date of the first documented darolutamide dose modification, assessed up to 39 months.
Document dose change. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until the date of the first documented darolutamide dose modification, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: dose change
Time Frame: From index date (Day 1) until the date of the first documented darolutamide dose modification, assessed up to 39 months.
Document dose change. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until the date of the first documented darolutamide dose modification, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: treatment interruption
Time Frame: From index date (Day 1) until the date of the first documented darolutamide interruption, assessed up to 39 months.
Document period of treatment interruption. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics. Interruptions shorter than 60 days will be considered ongoing treatment (i.e., not counted as a discontinuation).
From index date (Day 1) until the date of the first documented darolutamide interruption, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: treatment interruption
Time Frame: From index date (Day 1) until the date of the first documented darolutamide interruption, assessed up to 39 months.
Document period of tretament interruption. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics. Interruptions shorter than 60 days will be considered ongoing treatment (i.e., not counted as a discontinuation).
From index date (Day 1) until the date of the first documented darolutamide interruption, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: treatment discontinuation
Time Frame: From index date until permanent darolutamide discontinuation, assessed up to 39 months.
Document permanent treatment discontinuation. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date until permanent darolutamide discontinuation, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: treatment discontinuation
Time Frame: From index date until permanent darolutamide discontinuation, assessed up to 39 months.
Document permanent treatment discontinuation. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date until permanent darolutamide discontinuation, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period:switch to another Androgen receptor pathway inhibitor (ARPI)
Time Frame: From the index date until the date of new ARPI initiation, assessed up to 39 months.
Date of new ARPI initiation after index; if no prior darolutamide discontinuation recorded, use the day prior to the new ARPI start as darolutamide discontinuation. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From the index date until the date of new ARPI initiation, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period:switch to another Androgen receptor pathway inhibitor (ARPI)
Time Frame: From the index date until the date of new ARPI initiation, assessed up to 39 months.
Date of new ARPI initiation after index; if no prior darolutamide discontinuation recorded, use the day prior to the new ARPI start as darolutamide discontinuation. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From the index date until the date of new ARPI initiation, assessed up to 39 months.
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period:number of docetaxel cycles (if information is available)
Time Frame: Date of first docetaxel infusion that occurs within ±90 days of index through the last documented docetaxel infusion
Document number of docetaxel cycles. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Date of first docetaxel infusion that occurs within ±90 days of index through the last documented docetaxel infusion
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: adverse events
Time Frame: From index date (Day 1) through 30 days after recorded end-of-darolutamide treatment
Document adverse events. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) through 30 days after recorded end-of-darolutamide treatment
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: adverse events
Time Frame: From index date (Day 1) through 30 days after recorded end-of-darolutamide treatment
Document adverse events. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) through 30 days after recorded end-of-darolutamide treatment
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: comorbid conditions not recorded at baseline
Time Frame: From index date (Day 1) through recorded end of darolutamide treatment, up to 39 months.
Any new comorbid condition documented from the index date (date of first darolutamide/ARPI initiation) through the recorded end-of-darolutamide treatment in the PPS database. Document comorbid conditions. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) through recorded end of darolutamide treatment, up to 39 months.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period:comorbid conditions not recorded at baseline
Time Frame: From index date (Day 1) through recorded end of darolutamide treatment, up to 39 months.
Any new comorbid condition documented from the index date (date of first darolutamide/ARPI initiation) through the recorded end-of-darolutamide treatment in the PPS database. Document comorbid conditions. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) through recorded end of darolutamide treatment, up to 39 months.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: PSA response ≥90%
Time Frame: Evaluated at 3, 6, and 12 months from the index treatment.
Document PSA response ≥90%. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Evaluated at 3, 6, and 12 months from the index treatment.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period:PSA response ≥90%
Time Frame: Evaluated at 3, 6, and 12 months from the index treatment.
Document PSA response ≥90%. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
Evaluated at 3, 6, and 12 months from the index treatment.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: PSA decline to <0.2 ng/mL (undetectable)
Time Frame: Evaluated at 3, 6, and 12 months from the index treatment.
Document PSA decline to <0.2 ng/mL (undetectable). Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Evaluated at 3, 6, and 12 months from the index treatment.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: PSA decline to <0.2 ng/mL (undetectable)
Time Frame: Evaluated at 3, 6, and 12 months from the index treatment.
Document PSA decline to <0.2 ng/mL (undetectable). Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
Evaluated at 3, 6, and 12 months from the index treatment.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: initiation of next antineoplastic therapy
Time Frame: From index date (Day 1) until initiation of next antineoplastic therapy, assessed up to 39 months.
Document date of next antineoplastic therapy. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until initiation of next antineoplastic therapy, assessed up to 39 months.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: initiation of next antineoplastic therapy
Time Frame: From index date (Day 1) until initiation of next antineoplastic therapy, assessed up to 39 months.
Document date of next antineoplastic therapy. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until initiation of next antineoplastic therapy, assessed up to 39 months.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: radiographic progression to mCRPC
Time Frame: From index date (Day 1) until radiographic progression to mCRPC, assessed up to 39 months.
Document radiographic progression to mCRPC. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until radiographic progression to mCRPC, assessed up to 39 months.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: radiographic progression to mCRPC
Time Frame: From index date (Day 1) until radiographic progression to mCRPC, assessed up to 39 months.
Document radiographic progression to mCRPC. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until radiographic progression to mCRPC, assessed up to 39 months.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: all-cause mortality
Time Frame: From index date (Day 1) until death from any cause, assessed up to 39 months.
Date of death. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until death from any cause, assessed up to 39 months.
Describe treatment outcomes of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy) during the study period: all-cause mortality
Time Frame: From index date (Day 1) until death from any cause, assessed up to 39 months.
Date of death. Characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
From index date (Day 1) until death from any cause, assessed up to 39 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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