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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 (DEAR-EXT)

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Bayer

Status

Completed

Conditions

Non-metastatic Castration-resistant Prostate Cancer

Treatments

Drug: Darolutamide (BAY 1841788)
Drug: Apalutamide
Drug: Enzalutamide

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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. .

Enrollment

1,375 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

1,375 participants in 3 patient groups

Apalutamide
Treatment:
Drug: Apalutamide
Darolutamide
Treatment:
Drug: Darolutamide (BAY 1841788)
Enzalutamide
Treatment:
Drug: Enzalutamide

Trial contacts and locations

1

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Central trial contact

Bayer Clinical Trials Contact

Data sourced from clinicaltrials.gov

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