A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)
9 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
50
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Bayer Clinical Trials Contact
- Numer telefonu: 4930300139003
- E-mail: clinical-trials-contact@bayer.com
Lokalizacje studiów
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Many Locations, Indie
- Many locations
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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
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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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Incidence and severity of adverse events and serious adverse events
Ramy czasowe: 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
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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
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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
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Incidence of discontinuations and dose modifications of study drug due to adverse events
Ramy czasowe: 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
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Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in hematology laboratory parameters: hemoglobin
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: hematocrit
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: erythrocyte count
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: leukocyte count
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: lymphocytes
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: monocytes
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: eosinophils
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: neutrophils
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: basophils
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular hemoglobin
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular volume
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in hematology laboratory parameters: thrombocytes
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: albumin
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: alanine aminotransferase
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: aspartate aminotransferase
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: alkaline phosphatase
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: bilirubin total and direct
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: calcium
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: blood urea nitrogen
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: creatinine
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: serum glucose
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: total protein
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: lactate dehydrogenase
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: sodium
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: potassium
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: chloride
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: bicarbonate
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: testosterone
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: prothrombin time
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: specific gravity
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: pH, by dipstick
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: glucose, by dipstick
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: protein, by dipstick
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: blood, by dipstick
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: ketones, by dipstick
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in routine urinalysis parameters: microscopic examination
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Results of other safety laboratory tests
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Results of other safety laboratory tests performed as deemed necessary by the investigator
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Changes in Eastern Cooperative Oncology Group performance status and vitals
Ramy czasowe: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
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Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
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Incidence and severity of adverse events categorized as special topics
Ramy czasowe: 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
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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:
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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
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Drug administration status
Ramy czasowe: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
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Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
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From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
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Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
5 października 2026
Zakończenie podstawowe (Szacowany)
31 października 2028
Ukończenie studiów (Szacowany)
31 października 2028
Daty rejestracji na studia
Pierwszy przesłany
18 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 września 2026
Pierwszy wysłany (Rzeczywisty)
8 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
10 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 23276
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