2023-506698-36-00RecruitingPhase 3
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 27 Jun 2023
- Start date
- 2 Feb 2024
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Prostate cancer
- EU CT number
- 2023-506698-36-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread a little (low-volume) and still responds to hormone therapy. It tests stopping the extra drug after 12 months.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma with low-volume metastatic disease (M1a or M1b) found at diagnosis, confirmed by bone scan and CT or by PSMA-PET scan. Performance status ECOG 0, 1 or 2.
- Earlier treatment
- Hormone therapy (ADT) started within 6 weeks before joining. No other prior treatment for prostate cancer, such as other anti-androgens, CYP17 inhibitors, chemotherapy, immunotherapy or radiopharmaceutical agents.
Main reasons for not taking part
- Small cell, ductal or neuroendocrine prostate cancer
- Another cancer within 5 years, except squamous or basal cell skin cancer or non-invasive superficial bladder cancer
- History of seizures or medicines that lower the seizure threshold
- Any prostate cancer treatment other than ADT
- ADT started more than 6 weeks before joining
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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
Other
- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Stichting | Alkmaar | Netherlands | Recruiting |
| Ziekenhuisgroep Twente Stichting | Almelo | Netherlands | Recruiting |
| Meander Medisch Centrum | Amersfoort | Netherlands | Recruiting |
| Amsterdam UMC | Amsterdam | Netherlands | Recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting | Amsterdam | Netherlands | Recruiting |
| Wilhelmina Ziekenhuis Assen | Assen | Netherlands | Recruiting |
| Rode Kruis Ziekenhuis B.V. | Beverwijk | Netherlands | Recruiting |
| Deventer Ziekenhuis | Deventer | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Recruiting |
| Stichting Treant Ziekenhuiszorg | Emmen | Netherlands | Recruiting |
| Medisch Spectrum Twente | Enschede | Netherlands | Recruiting |
| ADRZ | Goes | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
| Spaarne Gasthuis Stichting | Haarlem | Netherlands | Recruiting |
| Tergooiziekenhuizen | Hilversum | Netherlands | Recruiting |
| Medisch Centrum Leeuwarden B.V. | Leeuwarden | Netherlands | Recruiting |
| Universiteit Maastricht | Maastricht | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Stichting | Nieuwegein | Netherlands | Recruiting |
| Canisius-Wilhelmina Hospital | Nijmegen | Netherlands | Recruiting |
| Laurentius Ziekenhuis Roermond | Roermond | Netherlands | Recruiting |
| Bravis Ziekenhuis | Roosendaal | Netherlands | Recruiting |
| Maasstad Ziekenhuis Stichting | Rotterdam | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
| Ikazia Ziekenhuis | Rotterdam | Netherlands | Recruiting |
| Sint Franciscus Vlietland Groep Stichting | Rotterdam | Netherlands | Recruiting |
| Haga Hospital | 's-Gravenhage | Netherlands | Recruiting |
| Haaglanden Medisch Centrum Stichting | 'S-Gravenhage | Netherlands | Recruiting |
| Stichting Viecuri Medisch Centrum voor Noord-Limburg | Venlo | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.