Observes darolutamide safety in men with advanced hormone-sensitive prostate cancer in India
Follows men with spreading prostate cancer who take darolutamide with hormone therapy.
Plain-language title generated from the registry record
Registry title: A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
Key facts
- Where
- Multiple Locations, IndiaSee the site
Where in India
- Many locationsMultiple Locations, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bayer
- Trial code
- NCT07806591
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Concomitant use or planned to start the use of docetaxel/any other androgen receptor inhibitors/radiation therapy/chemotherapy or immunotherapy; Any condition that, in investigator's opinion, precludes reliable safety follow-up; Known hypersensitivity to the study drug or any of its ingredients; Metastatic castration resistant prostate cancer (mCRPC) disease; Participation in an interventional clinical trial program with interventions outside of routine clinical practice.