Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07406282

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Hormone-sensitive Prostate Cancer Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company

Cleveland, Ohio, 44114-2619, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darolutamide

Drug

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Other names: Nubeqa

Abiraterone Acetate

Drug

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Enzalutamide

Drug

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Apalutamide

Drug

Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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).

  20. 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).

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: Double-DARE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.