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Taking people in SloveniaPhase 3

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.

Key facts

Who runs it
European Organisation for Research and Treatment of Cancer - EORTC
Where
Ljubljana, SloveniaSee the siteAlso in 9 other countries, 92 sites
Registry title
Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors
Status
Recruiting
Phase
Phase 3
People taking part
1,600 people, planned
Started
23 May 2025
Expected to end
1 Jun 2039
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • iMAB
  • cMAB
Record updated
19 September 2025

Who can take part

AI summary

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

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Slovenia

Also in 9 other countries, 92 sites

  • Institute of Oncology LjubljanaLjubljana, SloveniaTaking people

About the trial

What the trial wants to find out

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

The primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.

The 2 groups in the trial

  • Arm A - continuous treatmentExisting treatment, for comparison

    Arm A (cMAB): ADT (LHRH agonist or antagonist) + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide) continuously until start of a new anti-cancer therapy.

    Treatment: cMAB

  • Arm B - intermittent treatmentTreatment being tested

    Arm B (iMAB): no further treatment, including ADT and ARPI; decision to restart ADT (LHRH agonist or antagonist) and the initial ARPI (abiraterone, enzalutamide, apalutamide or darolutamide) is left at Investigator discretion.

    Treatment: iMAB

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.
Plain-language title
Testing On-and-Off Hormone Therapy for Men With Advanced Prostate CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05974774, who can take part
Record updated
19 September 2025