Меню
Идёт набор NCT07672119

A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide

— Наблюдательное Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: от 55 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

MACED: Major Adverse Cardiovascular Events Among Elderly Patients Treated With Enzalutamide or Darolutamide Among Patients With Advanced Prostate Cancer

Обзор

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.

Вмешательства

  • Другое No intervention
    Retrospective analysis using database without any intervention assigned in the study.

Первичные конечные точки

  • Incidence proportion and incidence rate (per 100 person-years) of 3-point major cardiovascular event (MACE) [Срок оценки: 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 [Срок оценки: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)]
Вторичные конечные точки (2)
  • Incidence proportion and incidence rate (per 100 person-years) of modified 3-point MACE (MACE-3m) [Срок оценки: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)]
  • Incidence proportion and incidence rate (per 100 person-years) of 4-point MACE [Срок оценки: Retrospective analysis from 01-Aug-2018 up to 31-Dec-2025 (or the most recent available data at the time of analysis)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Bayer — Whippany

Идентификаторы

NCT: NCT07672119 · 23348

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗