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DEAR-EXT: 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

Sponsor
Bayer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06013475
Collaborator
(none)
1,170
Enrollment
1
Location
12
Anticipated Duration (Months)
97.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. .

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
1170 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)
Anticipated Study Start Date :
Aug 31, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Reasons for ARI treatment discontinuation [Retrospective analysis from 01-Aug-2019 to 30 Sep 2023]

    2. Proportion of patients, who switched to another ARI therapy [Retrospective analysis from 01-Aug-2019 to 30 Sep 2023]

    3. Frequency of adverse events [Retrospective analysis from 01-Aug-2019 to 30 Sep 2023]

    4. Time to progression to mCRPC [Retrospective analysis from 01-Aug-2019 to 30 Sep 2023]

    5. Dose modification of initial ARI [Retrospective analysis from 01-Aug-2019 to 30 Sep 2023]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bayer Whippany New Jersey United States 07981

    Sponsors and Collaborators

    • Bayer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bayer
    ClinicalTrials.gov Identifier:
    NCT06013475
    Other Study ID Numbers:
    • 22625
    First Posted:
    Aug 28, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Aug 28, 2023