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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
The VTP procedure will consist of a single, 10 minute infusion of 4mg/kg TOOKAD® Soluble. The drug will be activated by laser light at 753nm, with a fixed energy of 200Joules/cm, and a fixed power of 150mWatts/cm, delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance.
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
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Number of patients with a negative biopsy.
Time frame: Month 12
Changes in urinary and erectile functions and their potential impact on quality of life using International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and the General quality of life (EQ5D) questionnaires.
Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described
Time frame: Screening, 1, 3, 6 and 12 months after completing treatment
The rate of adverse events.
Adverse event reporting.
Time frame: Screening-Month 12
The overall cancer burden in the prostate determined by biopsy as compared to baseline.
Total length of cancer present in all cores taken in any given biopsy session
Time frame: Month 12
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.
Time frame: Screening-Month 12
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