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NCT00116571 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

Official title:
A Phase II Randomized, Sham-Controlled, Double-Blind, Dose-Finding Study to Assess the Efficacy and Safety of Transurethral Photodynamic Therapy With Lemuteporfin in Subjects With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00116571
Other study ID # BPH 003
Secondary ID
Status Terminated
Phase Phase 2
First received June 29, 2005
Last updated October 2, 2006
Start date May 2005
Est. completion date December 2006

Study information
Verified date May 2006
Source QLT Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 180
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 21 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lemuteporfin for injection

Device:
• Transurethral drug delivery system

• Transurethral light delivery system

Locations
Country Name City State
Canada Can-Med Clinical Research Inc Victoria British Columbia
United States Duke University Medical Center Durham North Carolina
United States AccuMed Research Associates Garden City New York
United States Drs Werner, Murdock & Francis PA Urology Associates Greenbelt Maryland
United States Lawrenceville Urology Lawrenceville New Jersey
United States Urology San Antonio Research, PA San Antonio Texas
United States San Bernardino Urological Associates San Bernardino California
United States Regional Urology, LLC Shreveport Louisiana
United States Devine Tidewater Urology Virginia Beach Virginia

Sponsors (1)
Lead Sponsor Collaborator
QLT Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit
Secondary Responder rate
Secondary Change from baseline in Qmax
Secondary Change from baseline in post-void residual (PVR)
Secondary Shifts from baseline in subject responses to the BPH Quality of Life Impact Assessment
Secondary Safety outcomes: adverse events, clinical laboratory tests, vital signs, dysuria, and Male Sexual Health Questionnaire (MSHQ)
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