Could a 12-Month break from prostate cancer drugs be enough?
NCT ID NCT07260435
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.
Disclaimer
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the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Admiraal de Ruyter ziekenhuis
RECRUITINGGoes, Netherlands
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Amsterdam Universitair Medisch Centrum
NOT_YET_RECRUITINGAmsterdam, Netherlands
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Antoni van Leeuwenhoek
NOT_YET_RECRUITINGAmsterdam, Netherlands
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Bravis Ziekenhuis
RECRUITINGRoosendaal, Netherlands
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Canisius Wilhelmina Ziekenhuis
RECRUITINGNijmegen, Netherlands
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Catharina Ziekenhuis
RECRUITINGEindhoven, Netherlands
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Deventer Ziekenhuis
RECRUITINGDeventer, Netherlands
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Erasmus mc
RECRUITINGRotterdam, Netherlands
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Fransicus Gasthuis & Vlietland
RECRUITINGRotterdam, Netherlands
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Frisius MC Leeuwarden
RECRUITINGLeeuwarden, Netherlands
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HagaZiekenhuis
RECRUITINGThe Hague, Netherlands
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Laurentius Ziekenhuis
RECRUITINGRoermond, Netherlands
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Maasstad Ziekenhuis
RECRUITINGRotterdam, Netherlands
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Maastricht UMC
RECRUITINGMaastricht, Netherlands
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Meander MC Amersfoort
NOT_YET_RECRUITINGAmersfoort, Netherlands
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Medisch Spectrum Twente
RECRUITINGEnschede, Netherlands
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Noordwest Ziekenhuisgroep
RECRUITINGAlkmaar, Netherlands
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Rode Kruis Ziekenhuis
RECRUITINGBeverwijk, Netherlands
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Spaarne Gasthuis
RECRUITINGHaarlem, Netherlands
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St. Antonius Ziekenhuis
NOT_YET_RECRUITINGUtrecht, Netherlands
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Tergooi MC
NOT_YET_RECRUITINGHilversum, Netherlands
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Treant Zorggroep
RECRUITINGEmmen, Netherlands
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Universitair Medisch Centrum Groningen
RECRUITINGGroningen, Netherlands
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VieCuri Medisch Centrum
RECRUITINGVenlo, Netherlands
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Wilhelmina Ziekenhuis Assen
RECRUITINGAssen, Netherlands
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Ziekenhuisgroep Twente
RECRUITINGHengelo, Netherlands
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