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
- Barakaldo, Barcelona, Cáceres, Córdoba, L'Hospitalet de Llobregat, Lugo, Madrid, Majadahonda, Málaga, Oviedo, Palma, Pamplona, Sabadell, Santander, Sevilla, and Valladolid, SpainSee the 23 sites
- Phase
- Phase 3
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 Spain
- Hospital Universitario de CrucesBarakaldo, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Hospital San Pedro De AlcántaraCáceres, SpainTaking people
- Hospital General Universitario Reina SofiaCórdoba, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Fundacion Para La Investigacion Biomedica Del Hospital Gregorio MaranonMadrid, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario de la PrincesaMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- Hospital Universitario Regional de MálagaMálaga, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainTaking people
- University Hospital Son EspasesPalma, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Parc Tauli Hospital UniversitariSabadell, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpainTaking 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
- 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.