NCT07806591Not yet recruiting
A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India
An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 18 Aug 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 15 Nov 2028
- Lead sponsor
- Bayer
- Diseases
- Prostate cancer
- NCT number
- NCT07806591
What you commit to
- Study type: Observational
- Planned participants: 60
- From 30 Nov 2026 to the primary completion date, 15 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use or planned to start the use of docetaxel/any other androgen receptor inhibitors/radiation therapy/chemotherapy or immunotherapy
Other illness
- 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
Other
- Participation in an interventional clinical trial program with interventions outside of routine clinical practice
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Many locations Coordinator of this site? Confirm its status | Multiple Locations | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.