Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

NCT05974774 · tracked via the Priya Life Science France tracker

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Phase

Phase 3

Started

2025-05-23

Last updated

2025-09-19

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

iMABcMAB

iMAB: no treatment until significant PSA increase as per treating physician at which point patient restarts ADT (LHRH agonist or antagonist) + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide). Once PSA \< 0.2 ng/mL, treatment stops again.

cMAB: LHRH agonist or antagonist + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)

Study summary

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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

overall survival — 10 years from randomisation
the overall survival (OS) using an iMAB regimen is non-inferior to continuous treatment.
proportion of patients who do not restart their hormonal therapy within 1 year of interrupting their MAB therapy (given as part of the induction phase) — 1 year from stopping the MAB therapy
proportion of patients who do not restart within 1 year of interrupting their MAB therapy (given as part of the induction phase) is not less than 70%

Trial sites (9)

Facility	City	Region	Status
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
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05974774 on ClinicalTrials.gov ↗ ← All trials in France