Actively Recruiting
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
Led by Bayer · Updated on 2026-04-09
1400
Participants Needed
1
Research Sites
44 weeks
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. 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
Official 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 ARPI therapy during the patient identification period and within approximately 90 days from mHSPC diagnosis
- Age 18 years or older at the time of ARPI start
- Started ADT and/or docetaxel therapy within approximately 90 days from ARPI start
- Have at least 90 days of electronic medical record activity before starting ARPI
- Have at least 90 days of electronic medical record activity after starting ARPI 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 ARPI start or up to 90 days after de novo mHSPC 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
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
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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