A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)
2026. szeptember 9. frissítette: 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.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Beavatkozás / kezelés
Tanulmány típusa
Megfigyelő
Beiratkozás (Becsült)
50
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Bayer Clinical Trials Contact
- Telefonszám: 4930300139003
- E-mail: clinical-trials-contact@bayer.com
Tanulmányi helyek
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Many Locations, India
- Many locations
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
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.
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
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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.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Incidence and severity of adverse events and serious adverse events
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Changes in hematology laboratory parameters: hemoglobin
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. október 5.
Elsődleges befejezés (Becsült)
2028. október 31.
A tanulmány befejezése (Becsült)
2028. október 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. augusztus 18.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. szeptember 1.
Első közzététel (Tényleges)
2026. szeptember 8.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. szeptember 10.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. szeptember 9.
Utolsó ellenőrzés
2026. szeptember 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 23276
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .