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

NCT ID: NCT00116571

Last Updated: 2006-10-03

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Prostatic Hyperplasia

Keywords

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Benign Prostatic Hyperplasia (BPH) Photodynamic Therapy (PDT) Lower Urinary Tract Symptoms (LUTS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lemuteporfin for injection

Intervention Type DRUG

Transurethral drug delivery system

Intervention Type DEVICE

Transurethral light delivery system

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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QLT Inc.

INDUSTRY

Sponsor Role lead

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

Site Status

Regional Urology, LLC

Shreveport, Louisiana, United States

Site Status

Drs Werner, Murdock & Francis PA Urology Associates

Greenbelt, Maryland, United States

Site Status

Lawrenceville Urology

Lawrenceville, New Jersey, United States

Site Status

AccuMed Research Associates

Garden City, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Urology San Antonio Research, PA

San Antonio, Texas, United States

Site Status

Devine Tidewater Urology

Virginia Beach, Virginia, United States

Site Status

Can-Med Clinical Research Inc

Victoria, British Columbia, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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BPH 003

Identifier Type: -

Identifier Source: org_study_id