Recruiting

Darolutamide vs. Enzalutamide

Sponsor:

Bayer

Code:

NCT07672119

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 55+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT07672119

Start date

Jun 4, 2026

Status verified date

Jun 8, 2026

Completion date

Apr 29, 2027

Anticipated

Primary completion date

Apr 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 55+

Healthy Volunteers: Not accepted

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

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

No intervention

Retrospective analysis using database without any intervention assigned in the study.

Primary outcome measure

  • Incidence proportion and incidence rate (per 100 person-years) of 3-point major cardiovascular event (MACE) [ Time Frame: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis) ]
  • Estimation of the association of risk factors with 3-point MACE [ Time Frame: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis) ]

Central Contacts and Locations

Central contacts

Bayer Clinical Trials Contact

18888422937clinical-trials-contact@bayer.com

Locations

Bayer

Recruiting

Whippany, New Jersey, United States, 07981

Contacts

Bayer US

888-842-2937clinical-trials-contact@bayer.com

More Information

Sponsor

Bayer

Last update posted

Jun 26, 2026

Last verified

Jun 8, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bayer on 2026-06-26.