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NCT07672119 · ClinicalTrials.gov registry record
A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide
A clinical trial, sponsored by Bayer.
- Recruiting
- Registry status
- 3,000
- Enrollment target
NCT07672119 is a clinical trial that is actively recruiting participants, run by Bayer. The registered enrollment target is 3,000 participants.
The verdict
NCT07672119 is actively recruiting participants, sponsored by Bayer.
- RECRUITING
- Registry status
- 3,000 participants
- Enrollment target
Study Summary
This observational study aims to better understand the risk of serious heart-related problems in older men with advanced prostate cancer who are treated with certain commonly used medicines. Prostate cancer is the most commonly diagnosed malignancy in United States (US) men and a leading cause of cancer mortality, with disease progression spanning multiple clinical states, including non-metastatic castrate resident prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Men with advanced prostate cancer are often treated with medicines such as darolutamide or enzalutamide. While these treatments can help control cancer, they may also increase the risk of heart-related side effects, such as heart attack, stroke, or death related to heart and blood vessel disease. However, it is not yet clear whether these risks differ between the two treatments or which patients may be more likely to experience them. The main goal of the study is to compare how often serious heart-related events (such as heart attack, stroke, or death due to heart problems) occur in patients treated with these two medicines. The study will also explore other heart-related conditions and identify factors that may increase this risk. In this study, researchers will use existing healthcare data from the United States to look at men aged 55 years and older with advanced prostate cancer who have already been treated with either darolutamide or enzalutamide in routine clinical practice. No new treatments will be given as part of this research. Because this is a retrospective database study, there are no extra study visits, no extra blood tests, and no extra health check-ups required for participants.
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2026-06-04 |
| Est. Completion | 2027-04-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07672119
The ClinicalTrials.gov registry entry for NCT07672119 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 3,000 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 1 intervention - of which No intervention is the first listed.
NCT07672119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07672119 about?
NCT07672119 is a clinical study titled "A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide". This observational study aims to better understand the risk of serious heart-related problems in older men with advanced prostate cancer who are treated with certain commonly used medicines. Prostate cancer is the most commonly diagnosed malignancy in United States (US) men and a leading cause of c...
What is the current status of trial NCT07672119?
This trial is currently recruiting. The enrollment target is 3,000 participants. The study started on 2026-06-04. Estimated completion is 2027-04-29.
What interventions are being tested in trial NCT07672119?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT07672119?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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