An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

Completed

Conditions studied: Non-metastatic Castration-resistant Prostate Cancer

In brief

This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones. The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .

Key facts

Study ID

NCT06013475

Run by

Bayer

People needed

1375

Starts

2023-08-31

Expected to finish

2024-10-28

Last updated by the study team

2025-06-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men diagnosed with prostate cancer.
• Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation
• Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time
• Age ≥ 18 years at treatment start
• At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months.

You may not qualify if…

• Evidence of metastatic disease before or 30 days after treatment start
• Prior history of other primary cancers

Where it is running

• Bayer — Whippany, New Jersey, United States

Full record on ClinicalTrials.gov

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