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An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

Recruitingn/aAges 19 Years - anyMaleBayer
NCT06334120 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels. This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth. To l

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📋 Eligibility rules (as published)
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
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What it tests

  • Darolutamide (Nubeqa, BAY1841788)
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Where

1 site
Many locations
Multiple Locations, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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