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

Conditions

• Non-metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apalutamide — DRUG
  Decision by the treating physician
• Darolutamide (BAY 1841788) — DRUG
  Decision by the treating physician
• Enzalutamide — DRUG
  Decision by treating physician

Study Details

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 Dates

Start date

Aug 31, 2023

Status verified

Jun 2025

Primary completion

Jun 28, 2024

Completion

Oct 28, 2024

Study Design

Enrollment

1,375 participants (actual)

Arms

• Arm: Apalutamide
• Arm: Darolutamide
• Arm: Enzalutamide

Primary Outcome Measure

Time to ARI treatment discontinuation [ Time Frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023 ]

Locations (1)

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