NCT00918034

Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

A Phase 2 Study to Evaluate the Safety and Effectiveness of Using the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Who Are Candidates for Interventional Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Light Sciences Oncology · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).

Detailed description

This is a phase 2 study to evaluate the safety and effectiveness of using light-activated talaporfin sodium in patients with LUTS due to BPH who are candidates for interventional therapy. The eligible patient will undergo placement of a proprietary drug activator into the prostatic urethra. Following the placement of the drug activator, patients will receive talaporfin sodium at 1 mg/kg intravenously by slow push over 3-5 minutes. Fifteen minutes after injection a light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes. SAE reporting will occur from the day of treatment (Day 0) through end of study (month 12), inclusive. Any SAE that is still ongoing at the end of the study will be followed until assessed as chronic, stable or resolved.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	talaporfin sodium	LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)
DEVICE	Transurethral illumination with light emitting diodes	A light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes
PROCEDURE	Placement	Placement of device in prostate urethra

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-06-11
• Last updated: 2012-11-16

Locations

8 sites across 2 countries: Australia, New Zealand