Clinical trial NCT00116571: Photodynamic Therapy (PDT) for Lower Urinary Tract Symptoms (PLUS)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia (BPH)
Photodynamic Therapy (PDT)
Lower Urinary Tract Symptoms (LUTS)
Lead sponsor: QLT Inc.
Sponsor class: INDUSTRY
First posted: 2005-06-30
Enrollment: 180
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit
Secondary outcomes:
measure: Responder rate
measure: Change from baseline in Qmax
measure: Change from baseline in post-void residual (PVR)
measure: Shifts from baseline in subject responses to the BPH Quality of Life Impact Assessment
measure: Safety outcomes: adverse events, clinical laboratory tests, vital signs, dysuria, and Male Sexual Health Questionnaire (MSHQ)
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Greenbelt
country: United States
facility: Drs Werner, Murdock & Francis PA Urology Associates
state: Maryland
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: San Antonio
country: United States
facility: Urology San Antonio Research, PA
state: Texas
city: Virginia Beach
country: United States
facility: Devine Tidewater Urology
state: Virginia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc
state: British Columbia
Study officials:
affiliation: QLT Inc.
name: Graeme Boniface, PhD
role: STUDY_DIRECTOR
References: