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

Sponsored by QLT Inc.

About this trial

Last updated 19 years ago

Study ID

BPH 003

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
21+ Years
Male
Male

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 19 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

Exclusion Criteria

- Subjects who have had previous minimally invasive or surgical treatment for BPH.

- Subjects who have unsuitable prostate dimensions.