Prostate Cancer: ADT with Darolutamide

We are studying whether adding darolutamide to standard hormone therapy helps frail men with newly diagnosed metastatic prostate cancer live longer and feel better. This trial compares the new treatment to a placebo to assess its effectiveness.

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Darolutamide
Darolutamide is a substance that blocks male hormones' effects to help treat prostate cancer.

What experimental substances are being tested?

Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.

Bay 1841788

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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Grand Hopital De Charleroi
Oncology
Charleroi, Belgium
Pole Hospitalier Jolimont
Oncology
Fayt-lez-Manage, Belgium
Clinique Saint-Pierre
Oncology
Ottignies, Belgium

Sponsor: Unicancer
Last updated: Nov 26, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.