RECRUITING

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

Conditions

Metastatic Castration Sensitive Prostate Cancer (mCSPC)Cancer of the Prostate Prostate Neoplasms Prostate Cancer enzalutamide Xtandi apalutamide Erleada mCSPC metastatic castration-sensitive prostate cancer treatment duration metastatic hormone-sensitive prostate cancer mHSPC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Real-world Clinical Outcomes With Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Flatiron Health Electronic Health Records (EHR) Database

Quick Facts

Study Start:2025-07-21

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07086651

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Pfizer Inc

New York, New York, 10001

United States

Collaborators and Investigators

Sponsor: Pfizer

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-21

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2025-07-21

Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

enzalutamide
Xtandi
apalutamide
Erleada
mCSPC
metastatic castration-sensitive prostate cancer
treatment duration
metastatic hormone-sensitive prostate cancer
mHSPC

Additional Relevant MeSH Terms

Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Cancer of the Prostate
Prostate Neoplasms
Prostate Cancer