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OpenTrials
Completed

NCT Number: NCT06013475

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

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. .

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Key information

Conditions

Non-metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Bayer

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Apalutamide

Drug

Decision by the treating physician

Darolutamide (BAY 1841788)

Drug

Decision by the treating physician

Other names: Nubeqa

Enzalutamide

Drug

Decision by treating physician

Primary outcomes

  1. Time to ARI treatment discontinuation

    Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Secondary outcomes

  1. Reasons for ARI treatment discontinuation

    Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  2. Proportion of patients, who switched to another ARI therapy

    Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  3. Frequency of adverse events

    Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  4. Time to progression to mCRPC

    Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  5. Dose modification of initial ARI

    Time frame: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)

Acronym: DEAR-EXT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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