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

About This Trial

This study looks at medical records to learn how standard hormone-blocking medicines, such as darolutamide, work in everyday care.
It is for men whose prostate cancer was already found to have spread to other parts of the body when they were first diagnosed.
Because researchers are only reviewing information from routine doctor visits, you do not need to take a new experimental drug or attend extra clinic appointments.
The findings will help doctors better understand which combinations of approved treatments lead to the best results for future patients.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study looks at medical records to learn how standard hormone-blocking medicines, such as darolutamide, work in everyday care.

Study Details

Start Date: July 22, 2025
Lead Sponsor: Bayer

Full Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.