NCT06151418

A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces

Completed Results posted Last updated 4 June 2025

What this trial tests

trial testing Novel hormonal therapy in Prostatic Neoplasms in 2,313 participants. Completed in 23 April 2024.

Timeline

22 November 2023

Primary endpoint
23 April 2024

23 April 2024

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,313
Start date	22 November 2023
Primary completion	23 April 2024
Estimated completion	23 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Novel hormonal therapy (novel-hormonal-therapy) — full drug profile →

Conditions studied

• Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Duration of Therapy (DOT) Primary · From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months

DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of N

Group	Value	95% CI
Participant: NHT	18.5	17.0 – 19.8

Time to Next Therapy (TTNT) Secondary · From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months

TTNT was defined as the time from the index date to the initiation date of a new therapy. Initiation of a new therapy was defined by switching to a different NHT, switching to different therapies. Participants who did not initiate a new therapy were censored at the end of data availability or death, whichever came first. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Kaplan-Meier method was used for

Group	Value	95% CI
Participant: NHT	NA	NA – NA

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.