Shortened 12 months duration of androgen receptor signalling agent in combination with androgen deprivation therapy in patients with low-volume castration-sensitive prostate cancer: a randomized Nationwide Study
Key facts
- Where
- 's-Gravenhage, 'S-Gravenhage, Alkmaar, Almelo, Amersfoort, Amsterdam, Assen, Beverwijk, Deventer, Eindhoven, Emmen, Enschede, Goes, Groningen, Haarlem, Hilversum, Leeuwarden, Maastricht, Nieuwegein, Nijmegen, Roermond, Roosendaal, Rotterdam és Venlo, HollandiaSee the 28 sites
- Phase
- 3. fázis
Where in Hollandia
- Haga Hospital's-Gravenhage, HollandiaTaking people
- Haaglanden Medisch Centrum Stichting'S-Gravenhage, HollandiaTaking people
- Noordwest Ziekenhuisgroep StichtingAlkmaar, HollandiaTaking people
- Ziekenhuisgroep Twente StichtingAlmelo, HollandiaTaking people
- Meander Medisch CentrumAmersfoort, HollandiaTaking people
- Amsterdam UMCAmsterdam, HollandiaTaking people
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, HollandiaTaking people
- Wilhelmina Ziekenhuis AssenAssen, HollandiaTaking people
- Rode Kruis Ziekenhuis B.V.Beverwijk, HollandiaTaking people
- Deventer ZiekenhuisDeventer, HollandiaTaking people
- Catharina Ziekenhuis StichtingEindhoven, HollandiaTaking people
- Stichting Treant ZiekenhuiszorgEmmen, HollandiaTaking people
- Medisch Spectrum TwenteEnschede, HollandiaTaking people
- ADRZGoes, HollandiaTaking people
- Universitair Medisch Centrum GroningenGroningen, HollandiaTaking people
- Spaarne Gasthuis StichtingHaarlem, HollandiaTaking people
- TergooiziekenhuizenHilversum, HollandiaTaking people
- Medisch Centrum Leeuwarden B.V.Leeuwarden, HollandiaTaking people
- Universiteit MaastrichtMaastricht, HollandiaTaking people
- Sint Antonius Ziekenhuis StichtingNieuwegein, HollandiaTaking people
- Canisius-Wilhelmina HospitalNijmegen, HollandiaTaking people
- Laurentius Ziekenhuis RoermondRoermond, HollandiaTaking people
- Bravis ZiekenhuisRoosendaal, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Ikazia ZiekenhuisRotterdam, HollandiaTaking people
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaTaking people
- Sint Franciscus Vlietland Groep StichtingRotterdam, HollandiaTaking people
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2023-506698-36-00
- Record updated
- 2025. december 3.
- Original description
To evaluate whether the discontinuation of ARSIs 12 months after its initiation in low-volume metastatic castration-sensitive prostate cancer (mCSPC) patients with the possibility to restart treatment, is non-inferior to continued androgen receptor signaling inhibitors (ARSI), thereby sparing significant toxicity and costsRead full original descriptionShow less
Apa/Enza short study (Shortened 12 months duration of androgen receptor signalling agent in combination with androgen deprivation therapy in patients with low-volume metastatic castration-sensitive prostate cancer: a randomized nationwide trial
To evaluate whether the discontinuation of ARSIs 12 months after its initiation in low-volume metastatic castration-sensitive prostate cancer (mCSPC) patients with the possibility to restart treatment, is non-inferior to continued androgen receptor signaling inhibitors (ARSI), thereby sparing significant toxicity and costs
Inclusion: Male and ≥18 years of age; 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; Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form.
Exclusion: 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; 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; Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate.