A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide
MACED: Major Adverse Cardiovascular Events Among Elderly Patients Treated With Enzalutamide or Darolutamide Among Patients With Advanced Prostate Cancer
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.
Przegląd badań
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Bayer Clinical Trials Contact
- Numer telefonu: 18888422937
- E-mail: clinical-trials-contact@bayer.com
Lokalizacje studiów
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New Jersey
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Whippany, New Jersey, Stany Zjednoczone, 07981
- Rekrutacyjny
- Bayer
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Kontakt:
- Bayer US
- Numer telefonu: 888-842-2937
- E-mail: clinical-trials-contact@bayer.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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.
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Analiza retrospektywna z wykorzystaniem bazy danych bez jakiejkolwiek interwencji przypisanej w badaniu.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Incidence proportion and incidence rate (per 100 person-years) of 3-point major cardiovascular event (MACE)
Ramy czasowe: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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Risk will be estimated as the time from the index date to the first 3-point MACE event.
MACE: major cardiovascular event (composite of myocardial infarction [MI], stroke, or cardiovascular [CV] death)).
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Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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Estimation of the association of risk factors with 3-point MACE
Ramy czasowe: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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A multivariable Cox regression model will be performed to estimate the hazard ratio associated with each risk factor.
MACE: major cardiovascular event (MI, stroke or CV death).
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Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Incidence proportion and incidence rate (per 100 person-years) of modified 3-point MACE (MACE-3m)
Ramy czasowe: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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Risk will be estimated as the time from the index date to the first MACE-3m event.
MACE-3m: composite of acute MI, acute stroke, or all-cause death.
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Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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Incidence proportion and incidence rate (per 100 person-years) of 4-point MACE
Ramy czasowe: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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Risk will be estimated as the time from the index date to the first 4-point MACE event.
4-point MACE: composite of acute MI, acute stroke, CV death, or unstable angina/revascularization.
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Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 23348
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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