A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)
An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Bayer Clinical Trials Contact
- Numer telefonu: 4930300139003
- E-mail: clinical-trials-contact@bayer.com
Lokalizacje studiów
-
-
-
Many Locations, Indie
- Many locations
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
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
Jak projektuje się badanie?
Szczegóły projektu
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
|
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
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
|
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
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
|
|
|
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
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
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
|
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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 23276
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .