Can a drug plus precision radiation stop prostate cancer from spreading?

NCT ID NCT06625970

Recruiting now Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This phase III trial is testing whether adding the drug darolutamide and a precise, high-dose radiation technique (SBRT) to standard hormone therapy and radiation can help men with high-risk localized prostate cancer live longer without the cancer spreading. About 700 men will be randomly assigned to one of four treatment combinations to see which works best. The main goal is to measure how long it takes for the cancer to metastasize or for death from any cause to occur.

What this could mean

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

Active substance: darolutamide (an androgen receptor inhibitor) and stereotactic body radiotherapy (SBRT, a precise high-dose radiation technique)
What this could lead to: If successful, this combination could offer a new standard of care to delay or prevent cancer spread in men with high-risk localized prostate cancer, potentially improving survival.
What could go wrong: The trial is large and randomized, but results are not guaranteed. Darolutamide and higher radiation doses may increase side effects, and the benefit may not outweigh risks for all patients.

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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.

HIGH RISK PROSTATE CARCINOMA PROSTATE CANCER

Contacts and locations

Locations

CHU Martinique
RECRUITING

Fort-de-France, Martinique
CHU Saint-Etienne
RECRUITING

Saint-Etienne, France
Centre Georges Francois Leclerc
RECRUITING

Dijon, France
Clinique Pasteur Lanroze - Brest
RECRUITING

Brest, France
Groupe Hospitalier Paris Saint-Joseph
RECRUITING

Paris, France
Gustave Roussy, Cancer Campus, Grand Paris
RECRUITING

Villejuif, 94800, France

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