Prostatic NeoplasmsDouble-DARENCT07406282
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
An observational study of Prostatic Neoplasms and Metastatic Hormone-Sensitive Prostate Cancer, run by Bayer at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
- What is being tested?
- Darolutamide, Abiraterone acetate and Enzalutamide
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 30 Sep 2026
- 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: Adult men with de novo metastatic hormone-sensitive prostate cancer initiating androgen receptor pathway inhibitor therapy in US community urology clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company
Cleveland, Ohio, 44114-2619
About this study
Official title: 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.
- Being tested
- Darolutamide, Abiraterone acetate, Enzalutamide, Apalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarolutamideDrug
Also called Nubeqa
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Abiraterone acetateDrug
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
EnzalutamideDrug
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
ApalutamideDrug
Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide + ADT + docetaxel | Patients receiving darolutamide in combination with androgen deprivation therapy with docetaxel Receives: Drug: Darolutamide | |
| Abiraterone acetate + ADT + docetaxel | Patients receiving abiraterone acetate in combination with androgen deprivation therapy with docetaxel Receives: Drug: Abiraterone acetate | |
| Enzalutamide + ADT | Patients receiving enzalutamide in combination with androgen deprivation therapy Receives: Drug: Enzalutamide | |
| Apalutamide + ADT | Patients receiving apalutamide in combination with androgen deprivation therapy Receives: Drug: Apalutamide | |
| Darolutamide + ADT | Patients receiving darolutamide in combination with androgen deprivation therapy Receives: Drug: Darolutamide | |
| Abiraterone acetate + ADT | Patients receiving abiraterone acetate in combination with androgen deprivation therapy Receives: Drug: Abiraterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age
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.
Measured: Baseline
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): age
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Concomitant Medication
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Concomitant Medication
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.
Measured: Baseline
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): ethnicity
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.
Measured: Baseline
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): ethnicity
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Charlson Comorbidity Index
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Charlson Comorbidity Index
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Gleason Score
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Gleason Score
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): PSA
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): PSA
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): de novo mHSPC Diagnosis
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.
Measured: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): de novo mHSPC Diagnosis
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.
Measured: Baseline
Describe drug utilization patterns of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy) during the study period: initial dose
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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%
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.
Measured: 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%
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From index date (Day 1) until death from any cause, assessed up to 39 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start22 Jul 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406282
- Sponsor's protocol ID
- 23094
- Acronym
- Double-DARE
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07406282
- Acronym / sponsor ID
- Double-DARE / 23094
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Feb 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Darolutamide + ADT + docetaxel | – | Drug: DarolutamidePatients receiving darolutamide in combination with androgen deprivation therapy with docetaxel |
| Abiraterone acetate + ADT + docetaxel | – | Drug: Abiraterone acetatePatients receiving abiraterone acetate in combination with androgen deprivation therapy with docetaxel |
| Enzalutamide + ADT | – | Drug: EnzalutamidePatients receiving enzalutamide in combination with androgen deprivation therapy |
| Apalutamide + ADT | – | Drug: ApalutamidePatients receiving apalutamide in combination with androgen deprivation therapy |
| Darolutamide + ADT | – | Drug: DarolutamidePatients receiving darolutamide in combination with androgen deprivation therapy |
| Abiraterone acetate + ADT | – | Drug: Abiraterone acetatePatients receiving abiraterone acetate in combination with androgen deprivation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men with de novo metastatic hormone-sensitive prostate cancer initiating androgen receptor pathway inhibitor therapy in US community urology clinics
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| DarolutamideAlso: NubeqaAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer | Drug | Darolutamide + ADT, Darolutamide + ADT + docetaxel |
| Abiraterone acetateAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer | Drug | Abiraterone acetate + ADT, Abiraterone acetate + ADT + docetaxel |
| EnzalutamideAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer | Drug | Enzalutamide + ADT |
| ApalutamideAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer | Drug | Apalutamide + ADT |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Metastatic Hormone-Sensitive Prostate Cancer, run by Bayer at 1 site in United States.
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 6 inclusion and 4 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age (time frame: Baseline). The study lists 39 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 7 Jul 2026.