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

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.

Study Overview

• Status: Terminated
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: Lemuteporfin for injection; Device: Transurethral drug delivery system; Device: Transurethral light delivery system

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 Type: Interventional
• Enrollment: 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8T 5G1
      • Can-Med Clinical Research Inc
• United States
  • California
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Greenbelt, Maryland, United States, 20770
      • Drs Werner, Murdock & Francis PA Urology Associates
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrenceville Urology
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research, PA
  • Virginia
    • Virginia Beach, Virginia, United States, 23455
      • Devine Tidewater Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

• Sponsor: QLT Inc.
• Investigators: Study Director: Graeme Boniface, PhD, QLT Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion: December 6, 2022
• Study Completion: December 1, 2006

Study Registration Dates

• First Submitted: June 29, 2005
• First Submitted That Met QC Criteria: June 29, 2005
• First Posted (Estimate): June 30, 2005

Study Record Updates

• Last Update Posted (Estimate): October 3, 2006
• Last Update Submitted That Met QC Criteria: October 2, 2006
• Last Verified: May 1, 2006

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia (BPH); Photodynamic Therapy (PDT); Lower Urinary Tract Symptoms (LUTS)
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: BPH 003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No