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Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
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.
Official title: Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.
Key Details
Gender
MALE
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
1600
Start Date
2025-05-23
Completion Date
2039-06-01
Last Updated
2025-09-19
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (9)
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, Denmark
Centre Francois Baclesse
Caen, France
Institut Daniel Hollard
Grenoble, France
Clinique La Croix Du Sud
Quint-Fonsegrives, France
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
Toulouse, France
Gustave Roussy
Villejuif, France
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitario San Carlos
Madrid, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Spain