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

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QLT Inc.

Criteria

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.