A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)
9 сентября 2026 г. обновлено: Bayer
An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care.
The study aims to describe the real-world safety profile of darolutamide plus androgen deprivation therapy over up to 1 year of follow-up, including adverse events, serious adverse events, adverse events categorized as special topics, treatment changes, and changes in laboratory values, vital signs, and Eastern Cooperative Oncology Group performance status.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Наблюдательный
Регистрация (Оцененный)
50
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Bayer Clinical Trials Contact
- Номер телефона: 4930300139003
- Электронная почта: clinical-trials-contact@bayer.com
Места учебы
-
-
-
Many Locations, Индия
- Many locations
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
Male patients with a diagnosis of metastatic hormone sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with darolutamide has been made by the physician.
Описание
Inclusion Criteria:
- Men over the age of 18 years
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease (metastatic hormone sensitive prostate cancer) documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigators
- The decision to initiate treatment with darolutamide plus androgen deprivation therapy (ADT) was made as per the investigator's routine treatment practice
- Written informed consent
Exclusion Criteria:
- Participation in an interventional clinical trial program with interventions outside of routine clinical practice
- Any condition that, in investigator's opinion, precludes reliable safety follow-up.
- Concomitant use or planned to start the use of docetaxel/any other androgen receptor inhibitors/radiation therapy/chemotherapy or immunotherapy
- Known hypersensitivity to the study drug or any of its ingredients
- Metastatic castration resistant prostate cancer (mCRPC) disease
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Single-arm post marketing surveillance cohort
Patients with metastatic hormone-sensitive prostate cancer in India who are treated with darolutamide in combination with androgen deprivation therapy as part of routine clinical practice
|
Darolutamide 300 mg film-coated tablets in combination with androgen deprivation therapy (ADT).
The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence and severity of adverse events and serious adverse events
Временное ограничение: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
|
Occurrence of adverse events, including AE/SAE terms, dates, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, outcome, actions taken, and seriousness criteria
|
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
|
|
Incidence of discontinuations and dose modifications of study drug due to adverse events
Временное ограничение: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
|
Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
|
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Changes in hematology laboratory parameters: hemoglobin
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: hematocrit
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: erythrocyte count
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: leukocyte count
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: lymphocytes
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: monocytes
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: eosinophils
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: neutrophils
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: basophils
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: mean corpuscular hemoglobin
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: mean corpuscular volume
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in hematology laboratory parameters: thrombocytes
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: albumin
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: alanine aminotransferase
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: aspartate aminotransferase
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: alkaline phosphatase
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: bilirubin total and direct
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: calcium
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: blood urea nitrogen
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: creatinine
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: serum glucose
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: total protein
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: lactate dehydrogenase
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: sodium
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: potassium
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: chloride
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: bicarbonate
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: testosterone
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: prothrombin time
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in routine urinalysis parameters: specific gravity
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in routine urinalysis parameters: pH, by dipstick
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in routine urinalysis parameters: glucose, by dipstick
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in routine urinalysis parameters: protein, by dipstick
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in routine urinalysis parameters: blood, by dipstick
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in routine urinalysis parameters: ketones, by dipstick
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
Changes in routine urinalysis parameters: microscopic examination
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
Results of other safety laboratory tests
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Results of other safety laboratory tests performed as deemed necessary by the investigator
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
Changes in Eastern Cooperative Oncology Group performance status and vitals
Временное ограничение: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
Incidence and severity of adverse events categorized as special topics
Временное ограничение: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
|
Occurrence of adverse events categorized as special topics, including category, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, actions taken, hospitalization, and discontinuation. Special topics are defined as:
|
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
|
|
Drug administration status
Временное ограничение: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
|
Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
|
From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
5 октября 2026 г.
Первичное завершение (Оцененный)
31 октября 2028 г.
Завершение исследования (Оцененный)
31 октября 2028 г.
Даты регистрации исследования
Первый отправленный
18 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
1 сентября 2026 г.
Первый опубликованный (Действительный)
8 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 23276
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .