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Clinical trial Recruiting at 9 sites Phase 3 Interventional Ages 18 to 100 Men only

Intermittent hormone suppression with AR pathway inhibitors for metastatic prostate cancer

Official title: Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.

Run by European Organisation for Research and Treatment of Cancer - EORTC · NCT05974774 · Data updated 2026-11-12

This trial will test whether planned treatment breaks from continuous androgen‑deprivation plus AR pathway inhibitors work as well as staying on continuous therapy for men with metastatic hormone‑naïve prostate cancer who have very low PSA after 6–12 months of treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 100 Years
SexMen only
Enrollment1600 (estimated)
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Research network
Drugs / interventionsradiation
Locations9 sites (Copenhagen and 8 other locations)
StatusRecruiting
StartedMay 23, 2025
Main results expectedMay 23, 2035
Study endsJune 1, 2039
Registry record updatedSeptember 19, 2025
Trial IDNCT05974774 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with metastatic hormone‑naïve prostate cancer who have been on ADT plus an AR pathway inhibitor for 6–12 months and have a PSA ≤0.2 ng/mL, including those who received prior docetaxel or radiotherapy.

Probably not a fit

Patients unlikely to benefit include those with planned local radiation plus 2–3 years of hormone therapy for M1a disease, men who have had bilateral orchiectomy, those with interfering concurrent malignancies, or patients who have not met the PSA or treatment‑duration criteria.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase 3 trial comparing intermittent multiple androgen blockade (iMAB) versus continuous multiple androgen blockade (cMAB) in men with metastatic hormone‑naïve prostate cancer who achieve a PSA ≤0.2 ng/mL after 6–12 months of ADT combined with an AR pathway inhibitor. Patients who previously received docetaxel or radiotherapy may be eligible and participants are randomized to either planned treatment holidays or continued therapy until progression. The primary goal is to determine whether intermittent therapy provides a similar overall survival while reducing treatment duration, side effects, and resource use. Secondary objectives include effects on quality of life, toxicity profiles, and time to progression.

Why it matters

Potential benefit: If successful, intermittent therapy could maintain survival while reducing side effects, improving quality of life, and lowering treatment burden and costs.

How similar studies have gone: Intermittent ADT showed comparable survival to continuous ADT in some older trials before widespread use of AR pathway inhibitors, but combining intermittent schedules with modern ARPIs is relatively novel and unproven in phase 3.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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 who underwent or will undergo a bilateral orchiectomy
* 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

Where it's running

  • University Hospitals Copenhagen - Rigshospitalet
    Copenhagen, Denmark     Recruiting
  • Centre Francois Baclesse
    Caen, France     Recruiting
  • Institut Daniel Hollard
    Grenoble, France     Recruiting
  • Clinique La Croix Du Sud
    Quint-Fonsegrives, France     Recruiting
  • CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
    Toulouse, France     Recruiting
  • Gustave Roussy
    Villejuif, France     Recruiting
Show 3 more locations
  • Hospital De La Santa Creu I Sant Pau
    Barcelona, Spain     Recruiting
  • Hospital Universitario San Carlos
    Madrid, Spain     Recruiting
  • Hospital Universitario Puerta De Hierro
    Majadahonda, Spain     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.