Actively Recruiting

Phase 3
Age: 18Years - 100Years
MALE
NCT05974774

Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2025-09-19

1600

Participants Needed

9

Research Sites

731 weeks

Total Duration

On this page

Sponsors

E

European Organisation for Research and Treatment of Cancer - EORTC

Lead Sponsor

C

Cancer Trials Ireland

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

Who Can Participate

Age: 18Years - 100Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient treated with ADT and an ARPI for mHNPC for 6-12 months and presenting with a PSA 64 0.2 ng/mL
  • Patient may have received docetaxel and radiotherapy of the prostate and metastases
  • Patients with synchronous or metachronous metastases, high volume/risk or low volume/risk who fulfil the criteria can be included
  • Written informed consent given according to ICH/GCP and national/local regulations
Not Eligible

You will not qualify if you...

  • Patients with M1a on modern imaging (PET-Choline, PSMA, or Whole Body MRI) planned for radiation therapy and 2-3 years of hormone therapy
  • Patients who underwent or will undergo bilateral orchiectomy
  • Patients with prior or concurrent malignancy that may interfere with safety or efficacy assessment
  • Patients who received systemic anti-prostate cancer treatment not approved by EMA together with MAB or radical prostatectomy for M1 disease
  • Psychological, familial, sociological, or geographical conditions potentially hampering study compliance and follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 9 locations

1

University Hospitals Copenhagen - Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

2

Centre Francois Baclesse

Caen, France, 14076

Actively Recruiting

3

Institut Daniel Hollard

Grenoble, France

Actively Recruiting

4

Clinique La Croix Du Sud

Quint-Fonsegrives, France

Actively Recruiting

5

CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole

Toulouse, France

Actively Recruiting

6

Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

7

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain, 08041

Actively Recruiting

8

Hospital Universitario San Carlos

Madrid, Spain

Actively Recruiting

9

Hospital Universitario Puerta De Hierro

Majadahonda, Spain

Actively Recruiting

Loading map...

Research Team

E

EORTC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors | DecenTrialz