RecruitingPhase 3NCT05974774

Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

1,600 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether men with hormone-sensitive prostate cancer that has spread (metastatic) can safely take breaks from hormone therapy after their PSA drops very low, rather than continuing treatment continuously. **You may be eligible if...** - You have been treated with hormone therapy (ADT) plus a newer hormone-blocking drug for metastatic prostate cancer for 6–12 months - Your PSA level has dropped to 0.2 ng/mL or lower - You may also have received docetaxel or radiation as part of your treatment **You may NOT be eligible if...** - You are currently planned for radiation therapy with 2–3 years of hormone therapy for certain types of metastatic disease - You have had or are planning bilateral orchiectomy (surgical removal of both testicles) - You have another active cancer that could interfere with this study - You have received unapproved systemic prostate cancer treatments or had surgery for metastatic disease - Personal, social, or geographic factors would make it hard to follow the study schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGiMAB

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.

DRUGcMAB

LHRH agonist or antagonist + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)