Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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