How darolutamide with hormone therapy works for advanced prostate cancer in German practice

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 study observes men with metastatic hormone-sensitive prostate cancer in Germany who begin a combination of darolutamide and androgen-deprivation therapy as part of standard clinical practice. It aims to document outcomes such as prostate-specific antigen (PSA) responses and other clinical measures over time. Investigators will collect data from routine medical care to understand real-world effectiveness and safety of this treatment approach. The study does not assign treatments or randomize participants; treatment decisions are made by clinicians as part of usual care. Results may help clarify how this combination performs outside of controlled trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male patients aged ≥ 18 years
* Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate
* Metastatic disease by conventional or new generation imaging

  * Physician decision to initiate treatment with Darolutamide+ADT was made as per investigator's routine treatment practice prior to enrollment in the study
  * Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).

Exclusion Criteria:

* Darolutamide treatment started more than 30 days prior to study enrollment
* ADT treatment started more than 12 weeks before the start of treatment with darolutamide plus ADT
* Hypersensitivity to darolutamide or any other excipient
* Other prior systemic hormonal or anti-cancer treatment for mHSPC
* Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice

Where it's running

• Many
  Locations, Germany Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

Similar studies

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

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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.