A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)

Pfizer

Status

Not yet enrolling

Conditions

Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Prostate Neoplasms

Prostate Cancer

Cancer of the Prostate

Treatments

Drug: Enzalutamide

Drug: Apalutamide

Study type

Observational

Funder types

Industry

Identifiers

NCT07086651

C3431053

Details and patient eligibility

About

The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC.

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 study. 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 cancer clinics (Flatiron Health electronic health records).

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

Were identified to have mCSPC.
Started treatment with apalutamide or enzalutamide (index date) for mCSPC.
Were 18 years of age or older on the index date. Men in this study will be taking apalutamide or enzalutamide for treatment of their mCSPC. The study will compare how long men take apalutamide or enzalutamide. This study will use patient information from cancer clinics. Information from start of apalutamide or enzalutamide treatment until information is available in the database will be used to describe how long patients receive treatment.

Enrollment

1,300 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male patients diagnosed with metastatic prostate cancer
Initiated apalutamide or enzalutamide for the first-line treatment of metastatic castration-sensitive prostate cancer (mCSPC). Initiation date of first treatment defines the index date.
Index date on or after 1 January 2020
Evidence of androgen deprivation therapy (ADT) use between 90 days prior to the index date and 6 months following the index date
Age ≥18 years on the index date -≥6 months of clinical activity following the index date, unless the patient died

Exclusion criteria

Evidence of castration-resistance prior to the index date
Received chemotherapy, androgen receptor pathway inhibitor, radiopharmaceuticals, immunotherapy, PARP inhibitor, or estrogens prior to the index date
Evidence of ADT use between 1 year and 91 days prior to the index date
Had a prior history of other cancers