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

Non-metastatic Prostate Cancer Clinical Trial

— ARENA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06204302
• Other study ID #: 22704
• Status: Completed
• Start date: January 5, 2024
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Darolutamide (Nubeqa, BAY1841788)
Retrospective cohort analysis, using Komodo Research Database (KRD)
• Enzalutamide
Retrospective cohort analysis, using Komodo Research Database (KRD)
• Apalutamide
Retrospective cohort analysis, using Komodo Research Database (KRD)

Locations

Country	Name	City	State
United States	Bayer	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to ARI discontinuation (days) for apalutamide, darolutamide, and enzalutamide		Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Primary	Time to progression to metastatic prostate cancer (mPC) (days) for apalutamide, darolutamide, and enzalutamide		Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Secondary	Descriptive summary of patient characteristics by cohort during baseline		Retrospective analysis from index date 01 May 2019 up to 31 Dec 2022
Secondary	Descriptive summary of initiating prescribed daily dose of apalutamide, darolutamide, and enzalutamide		Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Secondary	Descriptive summary of initiating prescribed daily dose intensity of apalutamide, darolutamide, and enzalutamide		Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Secondary	Initiating dose changes (increase/decrease) of apalutamide, darolutamide, and enzalutamide (yes/no)		Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Secondary	Switching between apalutamide, darolutamide, and enzalutamide (yes/no)		Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Secondary	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.	Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023

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