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

NCT06204302 | Completed

• 1 other identifier: 22704
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-metastatic Prostate Cancer; Non-metastatic Castration-resistant Prostate Cancer

Keywords

nmPC; nmCRPC

Outcome Measures

Primary Outcomes (2)

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

  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

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

Secondary Outcomes (6)

• Descriptive summary of patient characteristics by cohort during baseline

  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

  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

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

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

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

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

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

Study Arms (3)

Darolutamide

Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Darolutamide as initial treatment.

Drug: Darolutamide (Nubeqa, BAY1841788)

Enzalutamide

Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Enzalutamide as initial treatment.

Drug: Enzalutamide

Apalutamide

Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Apalutamide as initial treatment.

Drug: Apalutamide

Interventions

Darolutamide (Nubeqa, BAY1841788) DRUG

Retrospective cohort analysis, using Komodo Research Database (KRD)

Darolutamide

Enzalutamide DRUG

Retrospective cohort analysis, using Komodo Research Database (KRD)

Enzalutamide

Apalutamide DRUG

Retrospective cohort analysis, using Komodo Research Database (KRD)

Apalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men diagnosed with nmPC who were prescribed a novel ARI for the first time will be identified from Komodo Research Dataset (KRD) in the US.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

MeSH Terms

Interventions

darolutamide; enzalutamide; apalutamide

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: January 5, 2024
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)