NCT06072196Completed
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
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3017 (actual)
- First submitted
- 2 Oct 2023
- Start date
- 4 Oct 2023
- Primary completion date
- 18 Dec 2024
- Lead sponsor
- Pfizer
- Diseases
- Prostate cancer
- NCT number
- NCT06072196
What you commit to
- Study type: Observational
- Participants enrolled: 3017
- From 4 Oct 2023 to the primary completion date, 18 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance
- Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date
Other illness
- Had a prior history of other cancers
Who the study is looking for
- Male with ≥ 1 diagnosis claim for prostate cancer
- Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
- Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date.
- Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date
- ≥65 years old 12 months prior to the index date
- Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death)
Age in the registry: 65 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Inc Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.