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

NCT06151418 | Completed Results

• 2 other identifiers: C3431052NCT06151418
• Study Type: observational
• Target: 2,313
• Locations: 1 country
• Sites: 1

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

Keywords

metastatic castration-sensitive prostate cancer; mCSPC; metastatic hormone-sensitive prostate cancer; mHSPC; enzalutamide; abiraterone; treatment duration; time to next therapy

Outcome Measures

Primary Outcomes (1)

• Duration of Therapy (DOT)

  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).

  From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months

Secondary Outcomes (1)

• Time to Next Therapy (TTNT)

  From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months

Study Arms (1)

Novel hormonal therapy cohort

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

Drug: Novel hormonal therapy

Interventions

Novel hormonal therapy DRUG

As provided in real-world setting

Also known as: Abiraterone(Yonsa, Zytiga), Apalutamide(Erleada), Enzalutamide(Xtandi)

Novel hormonal therapy cohort

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with metastatic castration-sensitive prostate cancer who initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) and met eligibility criteria will be included in the study. Patients will be identified from the National Veterans Affairs Health Care Network.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Pfizer Inc

New York, New York, 10001, United States

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; apalutamide; enzalutamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: November 22, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)