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Completed

NCT Number: 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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Pfizer Inc

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male with ≥ 1 diagnosis claim for prostate cancer
  • Had documented secondary metastasis code on or after the initial prostate cancer diagnosis
  • Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 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
  • ≥18 years old on index date
  • Continuous enrollment for at least 365 days before index date
  • Evidence to be castration-sensitive:
  • No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR
  • Diagnosis of hormone sensitive malignancy status within 90 days before the index date

Exclusion criteria

  • Evidence of castration-resistance prior to the index date
  • Received other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date
  • Had diagnosis code indicating hormone resistance prior to the index date
  • A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration
  • Had a prior history of other cancers (except non-melanoma skin cancer)
  • Participation in a clinical trial during the 30 days before the index date

Treatment and study plan

Novel hormonal therapy

Drug

As provided in real-world setting

Other names: Abiraterone(Yonsa, Zytiga), Apalutamide(Erleada), Enzalutamide(Xtandi)

Primary outcomes

  1. Duration of Therapy (DOT)

    Time frame: 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 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).

Secondary outcomes

  1. Time to Next Therapy (TTNT)

    Time frame: 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 analysis.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Astellas Pharma Inc

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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