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

NCT ID NCT05974774

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2039

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient treated with ADT and an ARPI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng/mL Note: Patient may have received docetaxel and radiotherapy of the prostate and metastases Note: Patients with synchronous or metachronous metastases, high volume/risk or low volume/risk who fulfil the criteria can be included. * Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations Exclusion Criteria: * Patients with M1a on modern imaging technique (PET-Choline or -PSMA or Whole Body MRI) for whom radiation therapy and 2-3 years of hormone therapy is planned * Patients who underwent or will undergo a bilateral orchiectomy * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment for this trial * Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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