A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)
9 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Bayer Clinical Trials Contact
- Número de teléfono: 4930300139003
- Correo electrónico: clinical-trials-contact@bayer.com
Ubicaciones de estudio
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Many Locations, India
- Many locations
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence and severity of adverse events and serious adverse events
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in hematology laboratory parameters: hemoglobin
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de octubre de 2026
Finalización primaria (Estimado)
31 de octubre de 2028
Finalización del estudio (Estimado)
31 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
18 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Publicado por primera vez (Actual)
8 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 23276
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .