The study, known as the PRESIDENT trial, will be one of the most significant trials in this field. Spanning seven years and involving at least 25 centres across the UK, it aims to answer a critical question: can surgery improve survival and quality of life for men whose prostate cancer has spread but remains limited?
Prostate cancer is the most common cancer in England, with one man dying from the disease every 45 minutes in the UK. For the disease to become fatal, it must spread beyond the prostate. However, emerging evidence suggests that when this spread is limited – referred to as oligo-metastatic disease – targeted treatment of the prostate itself may improve outcomes.
While prostate removal surgery (prostatectomy) has been shown to be safe and feasible in these patients, its impact on survival and quality of life remains unclear. The PRESIDENT trial will address this crucial evidence gap.
‘This study will investigate whether surgery as part of a multi-pronged strategy can improve both cancer outcomes and quality of life in men with oligo-metastatic prostate cancer,’ said Professor Sooriakumaran, Chief Investigator of the trial. ‘Surgery is standard of care for men with localised prostate cancer; we will investigate its role in men with advanced disease, the kind of prostate cancer that is a much greater threat to life.’
The trial will recruit 749 patients, with approximately half randomly assigned to undergo surgery. It stands apart from other studies in several key ways. PRESIDENT is the only trial in this field to:
- Use advanced molecular imaging (PSMA PET/CT) to precisely identify eligible patients.
- Apply the same cutting-edge imaging to assess outcomes.
- Include quality of life as part of its primary endpoint, using a ‘deterioration-free survival’ measure.
- Regularly update its treatment protocols every two years to reflect the latest advances in standard care.
These innovations position PRESIDENT as a world-leading study with the potential to reshape global clinical practice.
The trial builds on earlier work by Professor Sooriakumaran and the Surgical Interventions Trial Unit (SITU) at NDS, which ran the TRoMbone pilot study demonstrating that surgery is both safe and acceptable to patients in this setting. Patient and public involvement (PPI) has played a central role in shaping the trial, and patients with lived experience of prostate cancer are part of the study team and trial steering committee.
Efforts have also been made to ensure diverse participation, including targeted engagement to recruit men of Black ethnicity, who are disproportionately affected by prostate cancer, with around one in four expected to be diagnosed in their lifetime.
The study will be delivered by NDS SITU, with Professors Freddie Hamdy and Richard Bryant as co-investigators. Statisticians and methodologists from the Centre for Statistics in Medicine (CSM) and the Oxford Clinical Trials Research Unit (OCTRU) are also part of the team.
The grant has been awarded through the NIHR’s Health Technology Assessment (HTA) programme, part of the UK Department of Health and Social Care.