check_circleStudy Completed

Non-metastatic castration-resistant prostate cancer

Bayer Identifier:

22625

ClinicalTrials.gov Identifier:

NCT06013475

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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 Participants Requirements

Sex

Male

Age

18 - N/A
  • 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.
  • 1. Evidence of metastatic disease before or 30 days after treatment start
    2. Prior history of other primary cancers

Trial summary

Enrollment Goal
1375
Trial Dates
August 2023 - June 2024
Phase
N/A
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
BayerWhippany, 07981, United States

Primary Outcome

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

Secondary Outcome

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

Trial design

Use of Darolutamide, Enzalutamide and Apalutamide for non-metastatic castration-Resistant prostate cancer (nmCRPC) – EXTension of the DEAR real-world study (NCT05362149)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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