account_circleRecruiting

Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer

Bayer Identifier:
23094
ClinicalTrials.gov Identifier:
NCT07406282
EudraCT Number:
Not Available
EU CT Number:
Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
    - 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.
    - 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 summary

Enrollment Goal
1400
Trial Dates
July 2025 - February 2026
Phase
N/A
Could I Receive a placebo
No
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC CompanyCleveland, 44114-2619, United States of America

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    From index date (Day 1) until death from any cause, assessed up to 39 months.

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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