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Could a 12-Month break from prostate cancer drugs be enough?

NCT ID NCT07260435

Disease control Sponsor: Nick Beije 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether men with low-volume metastatic prostate cancer can safely stop taking certain hormone drugs (apalutamide or enzalutamide) after 12 months, instead of continuing indefinitely. 400 men will be randomly assigned to either stop or continue therapy, with the option to restart if their PSA levels rise. The goal is to see if a shorter treatment reduces side effects and costs without harming cancer control.

What this could mean

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

Active substance
Apalutamide or Enzalutamide (androgen receptor pathway inhibitors)
What this could lead to
If successful, this could allow men with low-volume metastatic prostate cancer to take a break from strong hormone therapy after 12 months, reducing side effects and costs without worsening outcomes.
What could go wrong
This is a phase 3 trial, but it only includes men with low-volume disease, so results may not apply to others. There is a risk that stopping therapy early could allow cancer to progress, even with the option to restart treatment.

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 400 people

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

Started

Feb 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Male and ≥18 years of age * Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form * Histological diagnosis of prostate adenocarcinoma * Low volume de novo metastatic disease (M1a or M1b) defined as anything other than fitting the criteria for high-volume metastatic disease, e.g., four or more bone lesions with one or more lesions in any body structure beyond the spine or pelvis, or visceral disease (non-nodal). This has been assessed by either bone scan and computed tomography (CT), or PSMA-PET scan. Low-volume disease has subsequently been confirmed by the local (multidisciplinary) team after consideration of the available imaging results as per the standard imaging protocol for the site. * ADT initiated within 6 weeks prior to inclusion * Eastern Cooperative Oncology Group (ECOG) performance scale status of 0, 1 or 2 * Fit for treatment with apalutamide or enzalutamide according to treating physician Exclusion Criteria: * Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate * Other prior malignancy less than or equal to 5 years prior to randomization except for squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer * History of seizures or medications known to lower seizure threshold * Any other prior treatment for prostate cancer other than ADT (e.g., other next generation anti-androgens or other CYP17 inhibitors, chemotherapy, immunotherapy, or radiopharmaceutical agents) * ADT started more than 6 weeks before inclusion

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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

    26 sites. 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

  • Admiraal de Ruyter ziekenhuis

    RECRUITING

    Goes, Netherlands

  • Amsterdam Universitair Medisch Centrum

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • Antoni van Leeuwenhoek

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • Bravis Ziekenhuis

    RECRUITING

    Roosendaal, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    RECRUITING

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    RECRUITING

    Eindhoven, Netherlands

  • Deventer Ziekenhuis

    RECRUITING

    Deventer, Netherlands

  • Erasmus mc

    RECRUITING

    Rotterdam, Netherlands

  • Fransicus Gasthuis & Vlietland

    RECRUITING

    Rotterdam, Netherlands

  • Frisius MC Leeuwarden

    RECRUITING

    Leeuwarden, Netherlands

  • HagaZiekenhuis

    RECRUITING

    The Hague, Netherlands

  • Laurentius Ziekenhuis

    RECRUITING

    Roermond, Netherlands

  • Maasstad Ziekenhuis

    RECRUITING

    Rotterdam, Netherlands

  • Maastricht UMC

    RECRUITING

    Maastricht, Netherlands

  • Meander MC Amersfoort

    NOT_YET_RECRUITING

    Amersfoort, Netherlands

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, Netherlands

  • Noordwest Ziekenhuisgroep

    RECRUITING

    Alkmaar, Netherlands

  • Rode Kruis Ziekenhuis

    RECRUITING

    Beverwijk, Netherlands

  • Spaarne Gasthuis

    RECRUITING

    Haarlem, Netherlands

  • St. Antonius Ziekenhuis

    NOT_YET_RECRUITING

    Utrecht, Netherlands

  • Tergooi MC

    NOT_YET_RECRUITING

    Hilversum, Netherlands

  • Treant Zorggroep

    RECRUITING

    Emmen, Netherlands

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, Netherlands

  • VieCuri Medisch Centrum

    RECRUITING

    Venlo, Netherlands

  • Wilhelmina Ziekenhuis Assen

    RECRUITING

    Assen, Netherlands

  • Ziekenhuisgroep Twente

    RECRUITING

    Hengelo, Netherlands

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