NCT00116571

Photodynamic Therapy (PDT) for Lower Urinary Tract Symptoms (PLUS)

A Phase II Randomized, Sham-Controlled, Double-Blind, Dose-Finding Study to Assess the Efficacy and Safety of Transurethral Photodynamic Therapy With Lemuteporfin in Subjects With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (planned)
• Sponsor: QLT Inc. · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate. Photodynamic therapy (known as "PDT") is a treatment that uses light to make a drug work. This means the drug is "light-activated". Light-activated drugs do not work until a certain color of light shines on the drug. When the drug and the light combine, they react together to destroy tissue. This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary symptoms go back to normal.

Detailed description

This is a multi-center, randomized, sham-controlled, double-blind, dose-finding study in parallel groups of subjects with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). All subjects will receive a fixed dose of lemuteporfin injected transurethrally into the prostate followed by transurethral application of either one of three active light doses or a sham light dose. Subjects will be followed for safety and efficacy for a minimum of three months to a maximum of 12 months. The primary study endpoint will be the change from baseline in AUA SI score at three months.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Lemuteporfin for injection
DEVICE	Transurethral drug delivery system
DEVICE	Transurethral light delivery system

Timeline

• Start date: 2005-05-01
• Completion: 2006-12-01
• First posted: 2005-06-30
• Last updated: 2006-10-03

Locations

9 sites across 2 countries: United States, Canada