A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance
This is a Phase 3, multicentre, open label, randomised controlled study in subjects
diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.
Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects
will remain in the study for approximately 24 months following randomisation. A total of 400
subjects will be entered into the study; 200 will receive Active Surveillance and 200 will
receive TOOKAD® Soluble-VTP.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
Mark Emberton, Professor
University College of London Hospital , United Kingdom
Belgium: Federal Agency for Medicinal Products and Health Products