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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 55 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Advanced prostate cancer Participants will be assigned to mutually exclusive cohorts based on the index treatment of either enzalutamide or darolutamide and their diagnosis as mHSPC or nmCRPC.
  • Other: No intervention
    Retrospective analysis using database without any intervention assigned in the study.

Recruiting Locations

Bayer
Whippany, New Jersey 07981
Contact:
Bayer US
888-842-2937
clinical-trials-contact@bayer.com

More Details

Status
Recruiting
Sponsor
Bayer

Study Contact

Bayer Clinical Trials Contact
18888422937
clinical-trials-contact@bayer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.