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Clinical Trials/NCT00116571
NCT00116571TerminatedPhase 2

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

QLT Inc.18 sites in 2 countries180 target enrollmentStarted: May 1, 2005Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
QLT Inc.
Enrollment
180
Locations
18
Primary Endpoint
The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men 21 years of age and older.
  • Subjects with LUTS due to BPH with AUA SI scores of 13 and over and Qmax between 5 and 15 mL/sec.
  • Subjects with urethral treatment length of at least 25 mm.

Exclusion Criteria

  • Subjects who have had previous minimally invasive or surgical treatment for BPH.
  • Subjects who have unsuitable prostate dimensions.

Outcomes

Primary Outcomes

The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit

Secondary Outcomes

  • Responder rate
  • Change from baseline in Qmax
  • Change from baseline in post-void residual (PVR)
  • Shifts from baseline in subject responses to the BPH Quality of Life Impact Assessment
  • Safety outcomes: adverse events, clinical laboratory tests, vital signs, dysuria, and Male Sexual Health Questionnaire (MSHQ)

Investigators

Sponsor
QLT Inc.
Sponsor Class
Industry

Study Sites (18)

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