NCT01875393

Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Steba Biotech S.A. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2013-06-11
• Last updated: 2016-04-19

Locations

3 sites across 3 countries: Mexico, Panama, Peru