Bayer
Whippany, New Jersey, 07981, United States
NCT Number: NCT06204302
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.
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Notify Me18 year and older
Male
Observational
Whippany, New Jersey, 07981, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Retrospective cohort analysis, using Komodo Research Database (KRD)
Retrospective cohort analysis, using Komodo Research Database (KRD)
Retrospective cohort analysis, using Komodo Research Database (KRD)
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Time frame: Retrospective analysis from index date 01 May 2019 up to 31 Dec 2022
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
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.
Bayer
Industry
ARI Treatment Use and Outcomes in Non-metastatic Prostate Cancer (nmPC) Patients in the US
Acronym: ARENA
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.
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