Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer (PCM304)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- To confirm that a significant proportion of patients will be prostate cancer free on the biopsy. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]Number of patients with a negative biopsy.
- 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. [ Time Frame: Screening, 1, 3, 6 and 12 months after completing treatment ] [ Designated as safety issue: Yes ]Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described
- The rate of adverse events. [ Time Frame: Screening-Month 12 ] [ Designated as safety issue: Yes ]Adverse event reporting.
- The overall cancer burden in the prostate determined by biopsy as compared to baseline. [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]Total length of cancer present in all cores taken in any given biopsy session
- The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death [ Time Frame: Screening-Month 12 ] [ Designated as safety issue: Yes ]Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.
|Study Start Date:||May 2013|
|Study Completion Date:||March 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: TOOKAD® Soluble
TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.
Drug: TOOKAD® Soluble
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.
Other Name: WST11
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01875393
|Hospital General Tlahuac|
|Mexico DF, Mexico, 13278|
|Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez|
|Panama city, Panama|
|Hospital Nacional Cayetano Heredia|
|San Martin de Porres, Peru|
|Principal Investigator:||Jose Arturo Rodriguez Rivera, Dr||Hospital General Tlahuac|
|Principal Investigator:||Mary Lol Ve Mendoza Medina, Dr||Hospital General Tlahuac|
|Principal Investigator:||Luis Zegarra Montes, Professor||Hospital Nacional Cayetano Heredia|
|Principal Investigator:||Ramón Rodriguez, Professor||Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez|