(UroToday.com) The 2026 European Association of Urology (EAU) annual meeting featured a urology trials in bladder and prostate cancer session and a presentation by Dr. Prasanna Sooriakumaran discussing PRESIDENT, a randomized trial assessing prostatectomy in low-volume metastatic hormone-sensitive prostate cancer (mHSPC) using PSMA PET/CT as an endpoint.
Radical prostatectomy is a standard treatment for localized high-risk prostate cancer, and preliminary studies, including the TRoMbone feasibility study for the PRESIDENT trial, suggest it may offer improved oncological control and reduce local complications in low-volume mHSPC more effectively than radiotherapy. Other trials investigating radical prostatectomy in metastatic prostate cancer either include high-volume mHSPC for which surgery is unlikely to be of benefit, or do not include the most current standard of care treatment options. This trial aims to address these issues with a novel design incorporating best practice standard of care treatments and the use of molecular imaging with PSMA PET/CT for disease staging and response assessment.
The PRESIDENT trial aims to definitively evaluate this by comparing the primary outcome of "deterioration-free survival" in men treated with radical prostatectomy plus standard systemic therapy (ADT + androgen receptor pathway inhibitor +/- chemotherapy +/- radiotherapy) versus systemic therapy alone. Dr. Sooriakumaran and colleagues hypothesize that surgery delays health-related quality of life decline and metastatic progression, while also extending survival. Deterioration-free survival, therefore, was chosen to capture all of these changes and is an outcome widely used in oncology trials. Deterioration-free survival was defined as the time from randomization to the earliest event of:
- a 10-point deterioration in the overall health and quality of life based on the Global Health Status (GHS) score of the EORTC QLQ-C30 questionnaire, compared to a patient’s baseline score without subsequent recovery
- Metastatic progression
- Death from any cause
The trial will aim to recruit 749 men over 26 UK sites with newly diagnosed low-volume mHSPC (≤4 skeletal and/or extra-pelvic nodal metastases on PSMA PET/CT) who are suitable for radical prostatectomy. Participants will be randomized 1:1 to either the intervention (radical prostatectomy plus standard of care) or control (standard of care) arm. The study design includes an internal pilot phase for the first 22 months with a recruitment target of 58 men from 20 sites. The trial is projected to take 82 months in total, including 54 months of recruitment with a follow-up period of 1- 4.5 years
The anticipated impact is significant, potentially redefining the standard care pathway for low-volume mHSPC across the globe by offering improved oncological and quality of life outcomes. PRESIDENT is a £3 million NIHR-funded UK-wide landmark trial that is due to open in early 2026.
Presented by: Prasanna Sooriakumaran, Professor, University of Oxford, Oxford, United Kingdom
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2026 European Association of Urology (EAU) Annual Meeting, London, United Kingdom, Fri, Mar 13 – Mon, Mar 16, 2026.