A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Pfizer

Status

Completed

Conditions

Prostatic Neoplasms

Treatments

Drug: Novel hormonal therapy

Study type

Observational

Funder types

Industry

Identifiers

NCT06072196

C3431049

NCT06072196 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and 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. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.

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 insurance claim information from Medicare claims data.

The study will include patients' information from the database for men who:

Were identified to have mCSPC.
Started treatment with novel hormonal therapy (index date) for mCSPC.
Were 65 years of age or older one year before index date.

Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.

Enrollment

3,017 patients

Sex

Male

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male with ≥ 1 diagnosis claim for prostate cancer
Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 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.
Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date
≥65 years old 12 months prior to the index date
Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death)

Exclusion criteria

Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance
Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date
Had a prior history of other cancers