Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06204302 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 1,800
- Enrollment target
NCT06204302 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 1,800 participants.
The verdict
NCT06204302 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 1,800 participants
- Enrollment target
Study 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.
Interventions
- DRUG Apalutamide
- DRUG Enzalutamide
- DRUG Darolutamide (Nubeqa, BAY1841788)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2024-01-05 |
| Est. Completion | 2024-04-04 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06204302
The ClinicalTrials.gov registry entry for NCT06204302 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Apalutamide is the first listed.
NCT06204302 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06204302 about?
NCT06204302 is a clinical study titled "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 m...
What is the current status of trial NCT06204302?
This trial is currently completed. The enrollment target is 1,800 participants. The study started on 2024-01-05. Estimated completion is 2024-04-04.
What interventions are being tested in trial NCT06204302?
The interventions under investigation include: Apalutamide (DRUG), Enzalutamide (DRUG), Darolutamide (Nubeqa, BAY1841788) (DRUG).
Who is sponsoring clinical trial NCT06204302?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.