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
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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.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126, Italy
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CHU Dinant Godinne - UCL Namur
Yvoir, 5530, Belgium
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CHU de Dijon - Centre Georges-Francois-Leclerc
Dijon, 21079, France
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Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
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Fundacion Instituto Valenciano De Oncologia
Valencia, 46009, Spain
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Gustave Roussy
Villejuif, 94805, France
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Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
Brussels, 1070, Belgium
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Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
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Hospital Universitario Virgen De La Victoria
Málaga, 29010, Spain
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Hospital Universitario de Salamanca
Salamanca, 37007, Spain
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Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Badalona, 08916, Spain
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Universitair Ziekenhuis Gent
Ghent, 9000, Belgium