NCT07672119 A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide
| NCT ID | NCT07672119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bayer |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2027-04-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2026-06-04 with a primary completion date of 2027-04-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Male diagnosed with prostate cancer * Evidence of ≥2 prescription claims for enzalutamide or darolutamide during the identification period with the first occurrence of ARPI treatment defined as the index date * Male patients with a diagnosis of mHSPC or nmCRPC before or on the index date * Aged ≥55 years on the index date Exclusion Criteria: * Use of any of the ARPIs (abiraterone, apalutamide, enzalutamide, and darolutamide), Evidence of CRPC prior to the index date for mHSPC * Evidence of metastasis before index date + 30 days for nmCRPC
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07672119 clinical trial?
This trial is open to male participants only, aged 55 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07672119 currently recruiting?
Yes, NCT07672119 is actively recruiting participants. Contact the research team at clinical-trials-contact@bayer.com for enrollment information.
Where is the NCT07672119 trial being conducted?
This trial is being conducted at Whippany, United States.
Who is sponsoring the NCT07672119 clinical trial?
NCT07672119 is sponsored by Bayer. The trial plans to enroll 3,000 participants.
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