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

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Novel hormonal therapy

• Registration Number: NCT06151418
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study Start: 2023-11-22
• Study First Posted: 2023-11-30
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novel hormonal therapy cohort	Novel hormonal therapy	Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC

Primary Outcome Measures

Name	Time	Method
Treatment duration	Up to 48 months	Duration of therapy will be defined as the time from the index date to the date of novel hormonal therapy (NHT) discontinuation for any reason. Discontinuation of the current NHT will be 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 comes first.

Secondary Outcome Measures

Name	Time	Method
Time to next therapy	Up to 48 months	Time to next therapy will be defined as the time from the index date to the initiation date of a new therapy. Patients who do not initiate a new therapy will be censored at the end of data availability or death, whichever comes first.

Trial Locations

Locations (1)

Pfizer Inc; 🇺🇸 New York, New York, United States