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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,400 (estimated)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Prostatic Neoplasms
• Metastatic Hormone-Sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Darolutamide	Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
DRUG	Abiraterone acetate	Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
DRUG	Enzalutamide	Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
DRUG	Apalutamide	Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Timeline

• Start date: 2025-07-22
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2026-02-12
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study