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RECRUITING
NCT05974774
PHASE3

Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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