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A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)

NCT07779590 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 4700

Last updated 2026-08-21

No results posted yet for this study

Summary

The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT). ADT is a hormone therapy used to stop testosterone from being released or to prevent it from acting on prostate cells. The study includes men with metastatic castration-sensitive prostate cancer (mCSPC). This is a cancer that has spread outside the prostate to other parts of the body, but can still be successfully managed by lowering male hormones like testosterone. The study uses data from the Flatiron's Prostate Cancer Panoramic Database. This data base contains information on prostate cancer patients such as their clinical characteristics, lab, vitals, treatments and outcomes.

This study is seeking participants included in the Flatiron Prostate Cancer Panoramic dataset who:

* Have a diagnosis of prostate cancer (PC) that has spread to other parts of the body
* With at least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011
* Has proof of treatment with enzalutamide or darolutamide in combination with ADT as a first line treatment
* The treatment with enzalutamide or darolutamide in combination with ADT is no more than 30 days prior to or 6 months after the mCSPC diagnosis date

All participants in this study received at least 1 dose of enzalutamide or darolutamide in combination with ADT. The experiences of the participants receiving the enzalutamide or darolutamide will be looked at.

Participants will take part in this study for at least 6 months. During this time, they will have at least 2 documented clinic visits from 01 January 2011 to 31 March 2026. These visits will be updated if newer information becomes available at the time of the analysis.

Conditions

  • Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Interventions

DRUG

darolutamide plus androgen deprivation therapy

As provided in real world setting

DRUG

Enzalutamide plus androgen deprivation therapy

As provided in real world setting

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-11-15
Completion
2026-11-15
FDA Drug
Yes

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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 NCT07779590 on ClinicalTrials.gov