An observational study in Non-metastatic Prostate Cancer and Non-metastatic Castration-resistant Prostate Cancer, sponsored by Bayer. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Bayer · Observational
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:
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,800 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Darolutamide as initial treatment.
Drug: Darolutamide (Nubeqa, BAY1841788)
Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Enzalutamide as initial treatment.
Drug: Enzalutamide
Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Apalutamide as initial treatment.
Drug: Apalutamide
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 to ARI discontinuation (days) for apalutamide, darolutamide, and enzalutamide
Time 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
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun 2023
Descriptive summary of patient characteristics by cohort during baseline
Time 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
Time 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
Time 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)
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Switching between apalutamide, darolutamide, and enzalutamide (yes/no)
Time 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.
Time frame: Retrospective analysis from index date 01 Aug 2019 up to 30 Jun2023
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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