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)

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

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. .

Study Overview

• Status: Completed
• Conditions: Non-metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: Apalutamide; Drug: Darolutamide (BAY 1841788); Drug: Enzalutamide

• Study Type: Observational
• Enrollment (Actual): 1375

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult men previously not treated with a novel antihormonal agent and starting the initial ARI treatment for nmCRPC during the study period, in US community urology practices

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Apalutamide	Drug: Apalutamide; Decision by the treating physician
Darolutamide	Drug: Darolutamide (BAY 1841788); Decision by the treating physician; Other Names: Nubeqa
Enzalutamide	Drug: Enzalutamide; Decision by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to ARI treatment discontinuation	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Secondary Outcome Measures

Outcome Measure	Time Frame
Reasons for ARI treatment discontinuation	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Proportion of patients, who switched to another ARI therapy	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Frequency of adverse events	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Time to progression to mCRPC	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
Dose modification of initial ARI	Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 22625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No