Testing On-and-Off Hormone Therapy for Men With Advanced Prostate Cancer
Compares intermittent and continuous hormone drug treatment in men with newly diagnosed metastatic prostate cancer.
Plain-language title generated from the registry record
Registry title: Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors
Key facts
- Where
- Cork, Dublin 18, Dublin 24, Dublin 4, Dublin 7, Dublin 8, Dublin 9, Galway, and Limerick, IrelandSee the 10 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. 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 and was not yet treated with hormones. They have had 6-12 months of hormone therapy plus an AR pathway inhibitor and now have a very low PSA.
- Age
- 18 to 100 years
- Sex
- Men only
- Disease stage
- Metastatic hormone naïve prostate cancer (mHNPC), including high or low volume or risk, and metastases found at diagnosis or later
- Earlier treatment
- Must have had ADT and an ARPI for mHNPC for 6-12 months. Docetaxel and radiotherapy of the prostate and metastases are allowed.
- Biomarker or test result
- PSA of 0.2 ng/mL or lower
Main reasons for not taking part
- M1a disease on modern imaging (PET-Choline, PET-PSMA or whole body MRI) when radiation therapy and 2-3 years of hormone therapy are planned
- Had or will have both testicles removed (bilateral orchiectomy)
- Another past or current cancer that could affect the safety or results of the trial
- Had a systemic anti-prostate cancer treatment not approved by EMA together with MAB, or a radical prostatectomy for M1 disease
- Any personal, family, social or travel-related situation that could make it hard to follow the trial plan
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT05974774, who can take part
Where in Ireland
- Cork University HospitalCork, IrelandTaking people
- Beacon HospitalDublin 18, IrelandTaking people
- Tallaght University HospitalDublin 24, IrelandTaking people
- St Vincent's University HospitalDublin 4, IrelandTaking people
- Mater Misericordiae University HospitalDublin 7, IrelandTaking people
- Mater Private HospitalDublin 7, IrelandTaking people
- St James's HospitalDublin 8, IrelandTaking people
- Beaumont HospitalDublin 9, IrelandTaking people
- University Hospital GalwayGalway, IrelandTaking people
- University Hospital LimerickLimerick, IrelandTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- European Organisation for Research and Treatment of Cancer - EORTC
- Trial code
- NCT05974774EU 2023-506817-23-01
- Record updated
- 19 September 2025
- Original description
This study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization.Read full original descriptionShow less
Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.
This study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization.
The primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.
Inclusion: Patient treated with ADT and an ARPI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng/mL Note: Patient may have received docetaxel and radiotherapy of the prostate and metastases Note: Patients with synchronous or metachronous metastases, high volume/risk or low volume/risk who fulfil the criteria can be included; Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion: Patients with M1a on modern imaging technique (PET-Choline or -PSMA or Whole Body MRI) for whom radiation therapy and 2-3 years of hormone therapy is planned; Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment for this trial; Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease; Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial; Patients who underwent or will undergo a bilateral orchiectomy.