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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

Qualifiers

Has an International Classification of Diseases (ICD) diagnosis of PC (ICD-9 185x or ICD-10 C61x)

At least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011

Has evidence of diagnosis of PC with an initial or metastatic diagnosis date.

Has evidence of treatment with enzalutamide or darolutamide in combination with ADT in the 1L mCSPC setting , on or after 01 August 2022.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • darolutamide plus androgen deprivation therapy
  • Enzalutamide plus androgen deprivation therapy

Treatment groups

4,700 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators