Observing the safety of darolutamide in Korean men with prostate cancer
Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients
This study is testing the safety of darolutamide in Korean men with prostate cancer to see how well it works as part of their regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | Male |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06334120 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of darolutamide, a treatment already available for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), in Korean male patients. Participants will receive darolutamide as part of their routine treatment, and the study will monitor their safety outcomes. The drug works by blocking androgen receptors in prostate cells, which helps to delay cancer growth. The study will include men aged 19 and older who meet specific criteria related to their prostate cancer diagnosis.
Who should consider this trial
Good fit: Ideal candidates for this study are Korean men aged 19 and older with high-risk non-metastatic castration-resistant prostate cancer or metastatic hormone-sensitive prostate cancer.
Not a fit: Patients who are currently participating in other investigational programs or have contraindications to darolutamide will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data that may enhance treatment protocols for prostate cancer in Korean patients.
How similar studies have performed: While darolutamide has been studied in various populations, this specific observational study focusing on Korean patients is novel and aims to gather localized safety data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male aged ≥19 years * Patients with high risk nmCPRC * Castrate level of serum testosterone (\< 1.7 nmol/l \[50 ng/dL\]) * PSA doubling time \< 10 months * Patients with mHSPC * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography (CT), or magnetic resonance imaging (MRI). * be candidates for androgen-deprivation therapy with/without docetaxel. * Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice * Written informed consent from subject or legal representative; assent from subject when appropriate Exclusion Criteria: * Patients participating in an investigational program with interventions outside of routine clinical practice * Participants with contraindication according to the locally approved prescribing information
Where this trial is running
Multiple Locations
- Multiple locations — Multiple Locations, South Korea (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.