A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India

Condition(s) studied

Investigational drug(s) / intervention(s)

Darolutamide plus androgen deprivation therapy: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence and severity of adverse events and serious adverse events — 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
• Incidence of discontinuations and dose modifications of study drug due to adverse events — 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

Trial sites (1)

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