NCT06072196

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Novel Hormonal Therapies (NHTs) for the Treatment of Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Medicare Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,017 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide. Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery. This is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use insurance claim information from Medicare claims data. The study will include patients' information from the database for men who: * Were identified to have mCSPC. * Started treatment with novel hormonal therapy (index date) for mCSPC. * Were 65 years of age or older one year before index date. Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Novel hormonal therapy	As provided in real-world setting

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2023-10-10
• Last updated: 2025-12-31
• Results posted: 2025-12-31

Locations

1 site across 1 country: United States