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

Recruiting now

Conditions studied: Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer

In brief

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 facts

Study ID

NCT07406282

Run by

Bayer

People needed

1400

Starts

2025-07-22

Expected to finish

2026-09-30

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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