Observing the safety of darolutamide in Korean men with prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Many locations
  Many Locations, South Korea Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 0018888422937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JUR-003 in adults with advanced prostate cancer

  This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.

  Recruiting at 4 sites Phase 1 TCG Labs Soleil · Grand Rapids, Michigan and 3 other locations · NCT07824349

• Darolutamide plus ADT for men with non-metastatic prostate cancer that progressed after prior ADT+bicalutamide

  This study tests whether adding darolutamide to ongoing androgen deprivation therapy helps men with non-metastatic castration-resistant prostate cancer who previously progressed on bicalutamide plus ADT.

  Recruiting Bayer · Multiple Locations · NCT07538843

• Tracking apalutamide use in men with metastatic hormone-sensitive prostate cancer in France

  This project will see if men with metastatic hormone-sensitive prostate cancer in France take apalutamide as prescribed during their first year of treatment.

  Recruiting Janssen Cilag S.A.S. · Caen · NCT07451002

• Darolutamide with hormone therapy (± chemotherapy) in metastatic hormone-sensitive prostate cancer

  This real-world study tests whether darolutamide plus hormone therapy, with or without chemotherapy, helps men with metastatic hormone-sensitive prostate cancer achieve very low PSA levels and stay safe.

  Recruiting at 10 sites Bayer · Many Locations and 15 other locations · NCT07344779

• ASP5541 with prednisone and ADT for Chinese men with prostate cancer

  This study tests whether giving ASP5541 together with prednisone and ongoing androgen-deprivation therapy is safe and how the medicine behaves in Chinese men with metastatic prostate cancer.

  Recruiting Phase 1 Astellas Pharma Inc · Beijing, Beijing Municipality · NCT07339267

• Intensifying Treatment With Docetaxel and Apalutamide for Metastatic Hormone-Sensitive Prostate Cancer After a Partial PSA Response

  This trial tests whether adding docetaxel to apalutamide and ADT helps men with metastatic hormone-sensitive prostate cancer who did not achieve a deep PSA response after initial apalutamide treatment.

  Recruiting Phase 3 Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD · Bayonne and 55 other locations · NCT07333066

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.