First Site Activated in EU-Funded DE-ESCALATE Clinical Trial on Advanced Metastatic Prostate Cancer
10 Jun 2025
The European Organisation for Research and Treatment of Cancer (EORTC) and Syreon Research Institute are delighted to announce the official start of DE-ESCALATE, a pragmatic Phase III clinical trial focusing on metastatic prostate cancer.
DE-ESCALATE is one of three research projects coordinated by EORTC, alongside LEGATO and STREXIT-2, which are also funded by the Horizon Europe Programme.
About metastatic prostate cancer
Prostate cancer is the most frequently occurring cancer in men and the third leading cause of cancer death in men.¹ Despite dramatic improvements in early diagnosis and local treatment, one out of five prostate cancer patients will die from their disease.² While data about the rates of metastasis are limited, about 22% of prostate cancer cases metastasize.3 Advanced metastatic prostate cancer is a heterogeneous disease, for which androgen deprivation therapy combined with an androgen receptor pathway inhibitor (ARPI) is the mainstay of treatment.
Metastatic prostate cancer patients suffer from low quality of life and very burdensome symptoms, including treatment-related side effects.
About DE-ESCALATE
The study 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. It is also designed to detect early if iADT has a negative impact on overall survival compared to continuous therapy.
Up to 1,600 patients are expected to be enrolled in this study across Europe. The clinical trial will be opened in 80 sites in the following 8 countries within the EORTC network (Belgium, Croatia, Czechia, Denmark, Italy, Portugal, Romania, Slovenia) and 30 sites across national networks in Ireland, France, and Spain.4
The study is designed with a strong focus on patient centricity, employing a patient-developed health questionnaire to better assess quality of life improvements.
DE-ESCALATE is managed by a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists, and patient representatives.
To compare the effectiveness of the health interventions tested within the study, Syreon Research Institute will deliver a cost-effectiveness analysis and will also oversee the health policy aspects of the dissemination of the study findings.
The DE-ESCALATE study may lead to improved patient survival and quality of life while also improve health system sustainability.
Read more about the EORTC projects funded by the EU here and visit the official project’s website:
https://deescalate-horizon.eu/
1. https://ecis.jrc.ec.europa.eu/sites/default/files/2023-12/prostate_cancer_En-Nov_2021.pdf
2. GRANT AGREEMENT – Project 101104574 — DE-ESCALATE
3. https://seer.cancer.gov/statfacts/html/prost.html
4. https://www.urotoday.com/video-lectures/prostate-cancer/video/3875-the-de-escalate-trial-intermittently-stopping-prostate-cancer-treatments-to-improve-quality-of-life-guillaume-grisay.html
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