Photodynamic Therapy (PDT) for Lower Urinary Tract Symptoms (PLUS)
- Conditions
- Prostatic Hyperplasia
- Registration Number
- NCT00116571
- Lead Sponsor
- QLT Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 180
- 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.
- Subjects who have had previous minimally invasive or surgical treatment for BPH.
- Subjects who have unsuitable prostate dimensions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (9)
Devine Tidewater Urology
🇺🇸Virginia Beach, Virginia, United States
Can-Med Clinical Research Inc
🇨🇦Victoria, British Columbia, Canada
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
San Bernardino Urological Associates
🇺🇸San Bernardino, California, United States
Urology San Antonio Research, PA
🇺🇸San Antonio, Texas, United States
Drs Werner, Murdock & Francis PA Urology Associates
🇺🇸Greenbelt, Maryland, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States