New pill could replace hormone shots for prostate cancer

NCT ID NCT02972060

Ongoing Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This phase 2 trial tests an oral drug called darolutamide (ODM-201) against standard hormone therapy (ADT) in men with prostate cancer that has not yet been treated with hormones. The main goal is to see if darolutamide can lower PSA levels as effectively as standard treatment after 24 weeks. About 61 men are participating, and the study is open-label, meaning everyone knows which treatment they receive.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: darolutamide (ODM-201)
What this could lead to: If successful, darolutamide could offer an effective oral alternative to standard hormone injections for controlling prostate cancer, potentially with fewer side effects.
What could go wrong: This is a small phase 2 trial (61 participants) and does not yet prove long-term benefit or safety. The results may not apply to all prostate cancer patients, and darolutamide may still cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PROSTATE CANCER

Contacts and locations

Locations

Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Ospedale Molinette

Torino, 10126, Italy
CHU Dinant Godinne - UCL Namur

Yvoir, 5530, Belgium
CHU de Dijon - Centre Georges-Francois-Leclerc

Dijon, 21079, France
Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium
Fundacion Instituto Valenciano De Oncologia

Valencia, 46009, Spain
Gustave Roussy

Villejuif, 94805, France
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

Brussels, 1070, Belgium
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Hospital Universitario Virgen De La Victoria

Málaga, 29010, Spain
Hospital Universitario de Salamanca

Salamanca, 37007, Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

Badalona, 08916, Spain
Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

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