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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Bayer
Study ID
NCT07406282
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Darolutamide — DRUG
    Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
  • 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

Study Details

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 Dates

Start date
Jul 22, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
1,400 participants (estimated)

Arms

  • Arm: Darolutamide + ADT + docetaxel
    Patients receiving darolutamide in combination with androgen deprivation therapy with docetaxel
  • Arm: Abiraterone acetate + ADT + docetaxel
    Patients receiving abiraterone acetate in combination with androgen deprivation therapy with docetaxel
  • Arm: Enzalutamide + ADT
    Patients receiving enzalutamide in combination with androgen deprivation therapy
  • Arm: Apalutamide + ADT
    Patients receiving apalutamide in combination with androgen deprivation therapy
  • Arm: Darolutamide + ADT
    Patients receiving darolutamide in combination with androgen deprivation therapy
  • Arm: Abiraterone acetate + ADT
    Patients receiving abiraterone acetate in combination with androgen deprivation therapy

Primary Outcome Measure

Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC CompanyClevelandOhio44114-2619-

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company· Cleveland, OH

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