CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,017 enrolled
Drug / intervention
Novel hormonal therapydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06072196
NCT06072196N/ACompleted

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

Pfizer·observational·Posted Oct 10, 2023·Updated Dec 31, 2025

In Brief

An observational study evaluating Novel hormonal therapy for Prostatic Neoplasms. Completed, enrolled 3,017 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstellas Pharma Inc

Timeline

N/ACompletedFinished
202420252026
First PostedOct 10, 2023
Enrollment StartOct 4, 2023
Primary CompletionDec 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.7 years ago

Interventions

Novel hormonal therapydrug

As provided in real-world setting