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INTERMITTENT ANDROGEN DEPRIVATION THERAPY IN THE ERA OF ANDROGEN RECEPTOR PATHWAY INHIBITORS; A PHASE 3 PRAGMATIC RANDOMISED TRIAL

Project description

Optimising prostate cancer treatment for better patient’s quality of life and sustainable healthcare

Prostate cancer is the most common cancer among men in Europe. While early detection and treatment have improved, advanced and metastatic forms of the disease still pose major challenges. Most patients undergo long-term hormone therapy that can cause fatigue, bone loss, and cardiovascular problems. Finding ways to reduce side effects is crucial. The EU-funded DE-ESCALATE project aims to explore whether intermittent intensified androgen deprivation therapy can safely replace continuous treatment. By comparing outcomes across Europe, the project aims to improve survival, enhance quality of life, and make care more sustainable and patient-centred.

Objective

Prostate Cancer is the most common cancer in European men. Despite dramatic improvements in early diagnostic and local treatment, one out of five prostate cancer patients will die from their disease. Despite progress in the past years, it remains critical to improve on the present strategy for advanced and metastatic prostate cancer. Within the proposed project, we will evaluate whether intermittent intensified androgen deprivation treatment (iADT) in metastatic prostate cancer is not inferior to continuous treatment in terms of oncological benefit while minimizing side effects and resource utilization and improving patient quality of life. The proposed clinical trial is designed to detect early if iADT has a negative impact on overall survival compared to continuous therapy. If successful, the outcomes of the project will define a new evidence-based standard of care for metastatic hormone sensitive prostate cancer. The proposed research could lead to improved patient survival and quality of life but also improve health system sustainability. This is a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists and patient representatives. The study design was successfully discussed with patients. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.

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Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-MISS-2022-CANCER-01

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Coordinator

ORGANISATION EUROPEENNE POUR LA RECHERCHE ET LE TRAITEMENT DU CANCER AISBL
Net EU contribution
€ 6 266 913,00
Address
Avenue E. Mounier 83
1200 Bruxelles / Brussel
Belgium
Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Links
Total cost
€ 6 266 913,75

Participants (5)