Actively Recruiting
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
Led by Bayer · Updated on 2026-04-09
1400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Prostate cancer is the most common non-skin cancer among men in the United States, and some men are diagnosed when the cancer has already spread, known as metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has evolved to include androgen deprivation therapy (ADT) combined with androgen receptor pathway inhibitors (ARPIs) and sometimes chemotherapy like docetaxel. Darolutamide is an ARPI approved for use in combination with ADT and docetaxel (triplet therapy) or with ADT alone (doublet therapy). This research aims to analyze real-world data to better understand how darolutamide and other ARPIs are used in clinical practice for newly diagnosed mHSPC patients in US urology clinics, filling gaps in knowledge about treatment patterns and outcomes. The study observes patients receiving different ARPI regimens, including darolutamide with ADT and docetaxel, abiraterone acetate with ADT and docetaxel, enzalutamide with ADT, apalutamide with ADT, and the doublet combinations of darolutamide or abiraterone acetate with ADT alone. Data are collected retrospectively from electronic medical records in community urology practices across the US. The analysis will describe patient characteristics, drug use patterns such as initial doses, dose changes, interruptions, and discontinuations, as well as clinical outcomes including PSA responses, adverse events, disease progression, and mortality. Participants' medical records will be reviewed for baseline demographics and clinical characteristics, treatment details, and follow-up outcomes up to 39 months. The study evaluates PSA levels at 3, 6, and 12 months, treatment tolerability, comorbid conditions, and progression to castration-resistant prostate cancer or death. This observational study does not involve active treatment assignment but gathers real-world evidence to support future research and inform treatment decisions for men with newly diagnosed metastatic hormone-sensitive prostate cancer.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with evidence of de novo metastatic hormone-sensitive prostate cancer during the study period
- Started androgen receptor pathway inhibitor therapy within 90 days of diagnosis
- Age 18 years or older at the start of ARPI treatment
- Initiated androgen deprivation therapy and/or docetaxel within 90 days of ARPI initiation
- At least 90 days of electronic medical record activity before starting ARPI
- At least 90 days of electronic medical record activity after ARPI start, unless the patient died earlier
You will not qualify if you...
- History of other primary cancers except non-melanoma skin cancer
- Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy, or radiopharmaceuticals before starting ARPI
- Evidence of castration resistance before or up to 90 days after metastatic hormone-sensitive prostate cancer diagnosis
- Participation in a clinical trial during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 39 months
Participants who receive androgen receptor pathway inhibitor therapy are observed for treatment utilization and health outcomes.
Visits and assessments occur according to routine clinical care and electronic medical record documentation
Trial Site Locations
Total: 1 location
1
Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company
Cleveland, Ohio, United States, 44114-2619
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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