Actively Recruiting
Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients with Non-metastatic Castration-resistant and Metastatic Hormone-sensitive Prostate Cancer
Led by Bayer · Updated on 2026-05-13
600
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of the drug darolutamide in Korean men with two types of prostate cancer: non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). NmCRPC is prostate cancer that has not spread and does not respond to lowered testosterone, while mHSPC has spread and can be treated by lowering testosterone. This observational study focuses on monitoring adverse events and understanding how well darolutamide works in these patients. In this study, male patients diagnosed with nmCRPC or mHSPC who have been prescribed darolutamide by their doctors will be followed. The dose and duration of darolutamide treatment are determined by the treating physician based on local guidelines. Participants will be observed as part of their usual care without additional experimental interventions. Participants will be in the study for one year, during which they visit their doctor every 2 to 4 months. At these visits, scans will check cancer status and blood samples will be taken. Patients will also report any medications they are taking and any adverse events experienced. Researchers will record the number and severity of adverse events and drug reactions, as well as other outcomes related to cancer progression and treatment. The overall study will last about six years.
CONDITIONS
Brief Title
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 519 years
- Diagnosed with high risk non-metastatic castration-resistant prostate cancer (nmCRPC) with castrate serum testosterone level (< 1.7 nmol/l [50 ng/dL]) and PSA doubling time less than 10 months
- Diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) confirmed by histology or cytology with metastases seen on bone scan, CT, or MRI
- Candidate for androgen-deprivation therapy with or without docetaxel
- Decision to start darolutamide treatment as first time made by investigator
- Provided written informed consent or assent when appropriate
You will not qualify if you...
- Participating in an investigational program with treatments outside routine clinical practice
- Contraindications to darolutamide according to local approved prescribing information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive Darolutamide treatment as decided by their physician, with treatment duration and dosage based on routine clinical care.
Visits occur according to routine clinical practice during treatment
Duration - 30 days
Participants are monitored for safety and outcomes for 30 days after the end of Darolutamide treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Multiple locations
Multiple Locations, South Korea
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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