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

Stopped early · Phase 2

Conditions studied: Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT00116571

Run by

QLT Inc.

People needed

180

Starts

2005-05-01

Expected to finish

2006-12-01

Last updated by the study team

2006-10-03

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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