The goal of this clinical trial is to evaluate the outcomes of a shorter treatment duration (12 months) with an androgen receptor pathway inhibitor (ARPI), in this study Apalutamide or Enzalutamide, in patients with low-volume, hormone-sensitive metastatic prostate cancer (mCSPC), with the possibility to restart treatment if needed. The main research question is whether discontinuation of ARPI therapy after 12 months, with the option to restart treatment upon disease progression, is non-inferior to continued ARPI therapy, potentially reducing toxicity and costs. Eligible patients will be randomized after completing 12 months of ARPI treatment, to one of the following two arms: 1. ADT + continued ARPI (Apalutamide or Enzalutamide) 2. ADT + ARPI discontinued after 12 months, with the option to resume ARPI in case of a confirmed PSA rise. The confirmatory PSA sample must be obtained at least 4 weeks after the initial rise. This study aims to minimize toxicity associated with prolonged use of ARPIs in patients with low-volume, hormone-sensitive metastatic prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
400
ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility to resume treatment with ARSI in case of a confirmed PSA rise.
ADT plus continued ARPI (apalutamide/enzalutamide) to the moment of progression
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
RECRUITINGMeander MC Amersfoort
Amersfoort, Netherlands
NOT_YET_RECRUITINGAmsterdam Universitair Medisch Centrum
Amsterdam, Netherlands
NOT_YET_RECRUITINGAntoni van Leeuwenhoek
Amsterdam, Netherlands
NOT_YET_RECRUITINGWilhelmina Ziekenhuis Assen
Assen, Netherlands
RECRUITINGRode Kruis Ziekenhuis
Beverwijk, Netherlands
RECRUITINGDeventer Ziekenhuis
Deventer, Netherlands
RECRUITINGCatharina Ziekenhuis
Eindhoven, Netherlands
RECRUITINGTreant Zorggroep
Emmen, Netherlands
RECRUITINGMedisch Spectrum Twente
Enschede, Netherlands
RECRUITING...and 16 more locations
Time to clinical progression free survival (cPFS) in both arms.
To prospectively evaluate whether shortened (12 months) treatment with ARPIs, with retreatment with ARPIs in case of PSA progression (defined according to PSA progression criteria) is non-inferior with respect to clinical progression free survival (boundary of max -10% at 48 months) to continued treatment with ARPI evaluated by comparing time to cPFS (as defined in primary endpoint) in both arms.
Time frame: From inclusion to the last day of treatment or moment of progression (whichever occurs first). Subjects will participate for 5 years, after randomization. In total, patients will participate for 6 years.
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