Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT06151418
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2023-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Novel Hormonal Therapy (NHT) for Treating Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC): An Analysis of National Veterans Affairs Health Care Network Data
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines:
* abiraterone,
* apalutamide,
* 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. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer.
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 information from National Veteran's Affairs (VA) Health Care Network.
The study will include patients' information from the database for men who:
* were identified to have mCSPC.
* started treatment with NHT for mCSPC.
* were 18 years of age or older at start of NHT.
Men in this study will be taking NHT for treatment of their mCSPC. The study will explain:
* how long men take the therapy.
* how long it takes to start next therapy.
This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT until information is available.
* abiraterone,
* apalutamide,
* 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. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer.
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 information from National Veteran's Affairs (VA) Health Care Network.
The study will include patients' information from the database for men who:
* were identified to have mCSPC.
* started treatment with NHT for mCSPC.
* were 18 years of age or older at start of NHT.
Men in this study will be taking NHT for treatment of their mCSPC. The study will explain:
* how long men take the therapy.
* how long it takes to start next therapy.
This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT until information is available.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCT06151418 | REGISTRY | ClinicalTrials.gov | View |