Study of the Efficacy and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer
The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical
trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under
Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and
urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate
Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6
months (± 2) and 12 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Number of patients with a negative biopsy.
Jose Arturo Rodriguez Rivera, Dr
Hospital General Tlahuac
Mexico: Federal Commission for Sanitary Risks Protection