Can focused ultrasound replace watchful waiting for prostate cancer?

NCT ID NCT03531099

Ongoing Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether focused high-intensity ultrasound (HIFU) can destroy low-risk prostate tumors without the side effects of radical treatments. Men aged 50-80 with a single, low-risk tumor will be randomly assigned to either HIFU or active surveillance (regular monitoring). The main goal is to see if HIFU reduces the number of men who eventually need radical treatment like surgery or radiation within four years.

What this could mean

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

Active substance: Focused high-intensity focused ultrasound (HIFU) therapy using the Focal One device
What this could lead to: If successful, this could offer a less invasive treatment option for low-risk prostate cancer, potentially reducing the need for radical surgery or radiation while avoiding the anxiety of watchful waiting.
What could go wrong: The trial is relatively small and early-stage, and HIFU may not completely eliminate the cancer, requiring additional treatments. There are also risks of side effects from the procedure itself.

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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

CHU de Toulouse - Hôpital de Rangueil

Toulouse, 31400, France
Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France
Clinique Saint-Vincent

Besançon, 25044, France
Clinique Urologique Nantes Atlantis

Saint-Herblain, 44800, France
Département d'Urologie, Institut Montsouris

Paris, 75014, France
Groupe Hospitalier Pellegrin - CHU

Bordeaux, 33076, France
Polyclinique du parc Rambot

Aix-en-Provence, 13100, France
Service d'Urologie CHRU de Lille, Hôpital HURIEZ

Lille, 59000, France
Service d'Urologie Générale de Santé - Hôpital Privé La Louvière

Lille, 59000, France
Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,

Lyon, 69437, France
Service d'Urologie, CHU de Guebwiller Colmar

Colmar, 68024, France
Service d'Urologie, Clinique Tivoli Ducos

Bordeaux, 33000, France
Service d'Urologie, Hôpital Foch

Suresnes, 92150, France
Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord

Marseille, 13915, France

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