Status:

COMPLETED

An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings

Lead Sponsor:

Bayer

Conditions:

Non-metastatic Castration-resistant Prostate Cancer

Eligibility:

MALE

18+ years

Brief Summary

This is an observational study in which patient data from the past on men with non-metastatic castration-resistant prostate cancer are studied. In observational studies, only observations are made wit...

Eligibility Criteria

Inclusion

  • Men diagnosed with prostate cancer
  • Diagnosis of castration-resistant prostate cancer (CRPC) prior to or during the patient identification period
  • Treatment with daro, enza, or apa initiated for the first time during the patient identification period for nmCRPC
  • Age ≥ 18 years at index date
  • At least 6 months of electronic medical records (EMR) activity after the index date unless the patient died earlier than 6 months

Exclusion

  • Evidence of metastatic disease before or 30 days after index date.
  • Prior history (within five years before index date) of other primary cancers, except for non-melanoma skin cancer
  • Patients with multiple SGARIs recorded at index date
  • Use of a NAH agent (daro, enza, apa or abiraterone acetate) prior to the index date
  • Evidence of inclusion in clinical trials during the study period.

Key Trial Info

Start Date :

April 4 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 30 2023

Estimated Enrollment :

870 Patients enrolled

Trial Details

Trial ID

NCT05362149

Start Date

April 4 2022

End Date

June 30 2023

Last Update

March 20 2024

Active Locations (1)

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1

Bayer

Whippany, New Jersey, United States, 07981