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

NCT ID NCT07260435

Recruiting now Disease control Sponsor: Nick Beije Source: ClinicalTrials.gov ↗

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.

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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

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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