check_circleStudy Completed

Non-metastatic prostate cancer, Non-metastatic castration-resistant prostate cancer

Bayer Identifier:

22704

ClinicalTrials.gov Identifier:

NCT06204302

EudraCT Number:

Not Available

EU CT Number:

Not Available
An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men with Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

Trial purpose

This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with ‘androgen receptor inhibitors’ (ARIs) including darolutamide, enzalutamide, and apalutamide. 

Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body.

Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information.

Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones. 

The main purpose of this study is to collect and study information from men with nmPC about:
•   the length of time they continued treatment with an ARI as prescribed by their doctors.
•   the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body.

Data will come from the participants’ information stored in a database called Komodo Research Dataset (KRD) in the US.

The data collected will be from May 2019 to June 2023.

Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Men diagnosed with prostate cancer (≥1 claim for prostate cancer).
    - Treatment with apalutamide, darolutamide or enzalutamide initiated for the first time in the nmPC stage during the patient identification period.
    - Age ≥ 18 years at index date
    - At least 6 months of continuous eligibility in medical and pharmacy benefits prior to the index date
    - At least 6-months of continuous eligibility only in pharmacy benefits after the index date unless patient died before 6 months.
  • - Patients with multiple ARIs recorded at index date
    - Use of an ARI agent or abiraterone acetate prior to the index date
    - Other cancer diagnosis (except prostate and skin cancer) during the 6-month baseline period
    - Evidence of metastatic disease any time before or 30 days after index date.
    - No claim with a diagnosis for hormone sensitive malignancy status (Z19.1) during the study period

Trial summary

Enrollment Goal
1800
Trial Dates
January 2024 - April 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
BayerWhippany, 07981, US

Primary Outcome

  • Time to ARI discontinuation (days) for apalutamide, darolutamide, and enzalutamide
    date_rangeTime Frame:
    Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
  • Time to progression to metastatic prostate cancer (mPC) (days) for apalutamide, darolutamide, and enzalutamide
    date_rangeTime Frame:
    Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023

Secondary Outcome

  • Descriptive summary of patient characteristics by cohort during baseline
    date_rangeTime Frame:
    Retrospective analysis from index date 01 May 2019 up to 31 Dec 2022
  • Descriptive summary of initiating prescribed daily dose of apalutamide, darolutamide, and enzalutamide
    date_rangeTime Frame:
    Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
  • Descriptive summary of initiating prescribed daily dose intensity of apalutamide, darolutamide, and enzalutamide
    date_rangeTime Frame:
    Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
  • Initiating dose changes (increase/decrease) of apalutamide, darolutamide, and enzalutamide (yes/no)
    date_rangeTime Frame:
    Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
  • Switching between apalutamide, darolutamide, and enzalutamide (yes/no)
    date_rangeTime Frame:
    Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
  • Proportion of days covered (PDC)
    PDC is calculated by dividing the total non-overlapping days of supply by the length of a fixed time interval (6, 12, 18, 24 months) and by the patient specific treatment duration.
    date_rangeTime Frame:
    Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023

Trial design

ARI treatment use and outcomes in non-metastatic prostate cancer (nmPC) patients in the US
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here for access to information about Bayer’s transparency standards and Bayer studies.Study_Synopsis-22704.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (3.0), Protocol (0.1), Results(0.1)