Skip to main content
OpenTrials
Completed

NCT Number: NCT06204302

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

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.

Completed

Looking for future studies?

Notify Me

Key information

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 (≥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.

Exclusion criteria

  • 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

Treatment and study plan

Darolutamide (Nubeqa, BAY1841788)

Drug

Retrospective cohort analysis, using Komodo Research Database (KRD)

Enzalutamide

Drug

Retrospective cohort analysis, using Komodo Research Database (KRD)

Apalutamide

Drug

Retrospective cohort analysis, using Komodo Research Database (KRD)

Primary outcomes

  1. Time to ARI discontinuation (days) for apalutamide, darolutamide, and enzalutamide

    Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023

  2. Time to progression to metastatic prostate cancer (mPC) (days) for apalutamide, darolutamide, and enzalutamide

    Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023

Secondary outcomes

  1. Descriptive summary of patient characteristics by cohort during baseline

    Time frame: Retrospective analysis from index date 01 May 2019 up to 31 Dec 2022

  2. Descriptive summary of initiating prescribed daily dose of apalutamide, darolutamide, and enzalutamide

    Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023

  3. Descriptive summary of initiating prescribed daily dose intensity of apalutamide, darolutamide, and enzalutamide

    Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023

  4. Initiating dose changes (increase/decrease) of apalutamide, darolutamide, and enzalutamide (yes/no)

    Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023

  5. Switching between apalutamide, darolutamide, and enzalutamide (yes/no)

    Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023

  6. Proportion of days covered (PDC)

    Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

ARI Treatment Use and Outcomes in Non-metastatic Prostate Cancer (nmPC) Patients in the US

Acronym: ARENA

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2024
Registry last updated
Apr 9, 2024

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.

Published trials that share one or more normalized conditions with this study.