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Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

NCT05974774 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2025-09-19

No results posted yet for this 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.

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)

Sponsors & Collaborators

  • Cancer Trials Ireland

    collaborator NETWORK

  • UNICANCER

    collaborator OTHER

  • Spanish Oncology Genito-Urinary Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Bertrand Tombal, Prof · Cliniques Universitaires de Saint Luc

  • Silke Gillessen, Prof · Oncology Institute of Southern Switzerland - Ospedale San Giovanni

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-23
Primary Completion
2035-05-23
Completion
2039-06-01

Countries

  • Denmark
  • France
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05974774 on ClinicalTrials.gov