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

StatusActive, Not Recruiting
PhaseNot specified
SponsorPfizer
Started

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Record History

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  1. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2026 to Aug 19, 2026
    • Eligibility criteria expanded, about 20 words
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
438 trials monitored
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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.
Trial Details
NCT Number NCT07779590
Lead Sponsor Pfizer
Conditions
(from sponsor)
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Enrollment 4,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov