New pill could replace hormone shots for prostate cancer

NCT ID NCT02972060

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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