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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06151418

Collaborator

Astellas Pharma Inc (Industry)

1,000

Enrollment

Location

11.3

Anticipated Duration (Months)

88.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: Novel hormonal therapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Title Not in Corporate Clinical Trial Registry (CCTR)

Anticipated Study Start Date :

Nov 21, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Novel hormonal therapy cohort Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC	Drug: Novel hormonal therapy As provided in real-world setting Other Names: Abiraterone(Yonsa, Zytiga) Apalutamide(Erleada) Enzalutamide(Xtandi)

Arm

Intervention/Treatment

Novel hormonal therapy cohort

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

Drug: Novel hormonal therapy

As provided in real-world setting

Other Names:

Abiraterone(Yonsa, Zytiga)

Apalutamide(Erleada)

Enzalutamide(Xtandi)

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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