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

NCT07086651 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1300

Last updated 2025-12-08

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Enzalutamide

As provided in real-world setting

DRUG

Apalutamide

As provided in real-world setting

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-21
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086651 on ClinicalTrials.gov