Photodynamic Therapy (PDT) for Lower Urinary Tract Symptoms (PLUS)
NCT ID: NCT00116571
Last Updated: 2006-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
180 participants
INTERVENTIONAL
2005-05-31
2006-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Lemuteporfin for injection
Transurethral drug delivery system
Transurethral light delivery system
Eligibility Criteria
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Inclusion Criteria
* 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 unsuitable prostate dimensions.
21 Years
MALE
No
Sponsors
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QLT Inc.
INDUSTRY
Principal Investigators
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Graeme Boniface, PhD
Role: STUDY_DIRECTOR
QLT Inc.
Locations
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San Bernardino Urological Associates
San Bernardino, California, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Drs Werner, Murdock & Francis PA Urology Associates
Greenbelt, Maryland, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
AccuMed Research Associates
Garden City, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Urology San Antonio Research, PA
San Antonio, Texas, United States
Devine Tidewater Urology
Virginia Beach, Virginia, United States
Can-Med Clinical Research Inc
Victoria, British Columbia, Canada
Countries
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Other Identifiers
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BPH 003
Identifier Type: -
Identifier Source: org_study_id