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

NCT ID: NCT06151418

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2313 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2024-04-23

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.

Conditions

Prostatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Novel hormonal therapy cohort

Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC

Novel hormonal therapy

Intervention Type: DRUG

As provided in real-world setting

Interventions

Novel hormonal therapy

As provided in real-world setting

Intervention Type: DRUG

Other Intervention Names

Abiraterone(Yonsa, Zytiga); Apalutamide(Erleada); Enzalutamide(Xtandi)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Inc

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3431052

To obtain contact information for a study center near you, click here.

Other Identifiers

C3431052

Identifier Type: -

Identifier Source: org_study_id

NCT06151418

Identifier Type: REGISTRY

Identifier Source: secondary_id