Periodic Reporting for period 2 - DE-ESCALATE (INTERMITTENT ANDROGEN DEPRIVATION THERAPY IN THE ERA OF ANDROGEN RECEPTOR PATHWAY INHIBITORS; A PHASE 3 PRAGMATIC RANDOMISED TRIAL)
Reporting period: 2024-06-01 to 2025-11-30
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 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.
With nearly 12 months of delay, the clinical trial was approved in April 2025 by regulators and ethics committees following a first wave of submitted countries (ES, FR, IE, DK, HR), and with a conditional approval in Belgium. During the review process. regulators requested many clarifications and required the postponement of the overall survival endpoint assessment. Nevertheless, the approved study design is pragmatic and fully in line with what was previously endorsed by EU reviewers. Belgium was recently authorised after a protocol amendment allowing single stage consent. The submission of the second wave of countries (IT, RO, CZ, and SI) is planned for January 2026 as approval of the protocol amendment authorising single consent is required prior to submission. The first clinical site authorised to recruit patients was in Denmark in May 2025. The first patient was enrolled in June 2025. As of the 30 November 2025, 20 clinical sites were authorised (27 clinical sites as of 30 January 2026, period 3) and 69/ 1600 patients have been recruited (118 patients recruited as of 30 January 2026, period 3). Clinical investigators are highly enthusiastic. Patient recruitment is expected to be completed by June 2028. The health economics activities were conducted as foreseen during this second period despite the delay with WP2 clinical trial. The communication activities were performed as foreseen during this second period.
It is too early. The project clinical trial has not started yet.