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Study of the Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer
The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.
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 general anesthesia. 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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Hospital General Tlahuac
Mexico City, Mexico
Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
Panama City, Panama
Hospital Nacional Cayetano Heredia
San Martín de Porres, Peru
Start Date
May 1, 2013
Primary Completion Date
December 1, 2014
Completion Date
March 1, 2015
Last Updated
April 19, 2016
81
ACTUAL participants
TOOKAD® Soluble
DRUG
Lead Sponsor
Steba Biotech S.A.
NCT05691465
NCT04550494
Data Source & Attribution
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