Could taking a break from hormone therapy be just as good for prostate cancer?

NCT ID NCT05974774

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

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is for men with metastatic hormone-sensitive prostate cancer who have already been on hormone therapy for 6-12 months and have very low PSA levels. It compares two approaches: stopping and restarting treatment based on PSA levels (intermittent) versus staying on treatment continuously. The goal is to see if the intermittent approach can maintain similar survival while reducing side effects and treatment burden.

What this could mean

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

Active substance: hormone therapy (androgen deprivation therapy plus AR pathway inhibitors like abiraterone, enzalutamide, apalutamide, or darolutamide)
What this could lead to: If successful, this could allow men with prostate cancer to take breaks from hormone therapy, reducing side effects and improving quality of life without shortening survival.
What could go wrong: This is a large phase 3 trial, but it is still possible that the intermittent approach may not be as effective as continuous therapy in controlling the cancer. Side effects from the drugs themselves remain a risk.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma 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 - Institut Claudius Regaud - IUCT oncopole
RECRUITING

Toulouse, France
Centre Francois Baclesse
RECRUITING

Caen, 14076, France
Clinique La Croix Du Sud
RECRUITING

Quint-Fonsegrives, France
Gustave Roussy
RECRUITING

Villejuif, 94805, France
Hospital De La Santa Creu I Sant Pau
RECRUITING

Barcelona, 08041, Spain
Hospital Universitario Puerta De Hierro
RECRUITING

Majadahonda, Spain
Hospital Universitario San Carlos
RECRUITING

Madrid, Spain
Institut Daniel Hollard
RECRUITING

Grenoble, France
University Hospitals Copenhagen - Rigshospitalet
RECRUITING

Copenhagen, Denmark

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