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

Sponsor

QLT Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00116571

Collaborator

(none)

180

Enrollment

Locations

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: Lemuteporfin for injection Device: Transurethral drug delivery system Device: Transurethral light delivery system	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

May 1, 2005

Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit []

Secondary Outcome Measures

Responder rate []
Change from baseline in Qmax []
Change from baseline in post-void residual (PVR) []
Shifts from baseline in subject responses to the BPH Quality of Life Impact Assessment []
Safety outcomes: adverse events, clinical laboratory tests, vital signs, dysuria, and Male Sexual Health Questionnaire (MSHQ) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Bernardino Urological Associates	San Bernardino	California	United States	92404
2	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
3	Drs Werner, Murdock & Francis PA Urology Associates	Greenbelt	Maryland	United States	20770
4	Lawrenceville Urology	Lawrenceville	New Jersey	United States	08648
5	AccuMed Research Associates	Garden City	New York	United States	11530
6	Duke University Medical Center	Durham	North Carolina	United States	27710
7	Urology San Antonio Research, PA	San Antonio	Texas	United States	78229
8	Devine Tidewater Urology	Virginia Beach	Virginia	United States	23455
9	Can-Med Clinical Research Inc	Victoria	British Columbia	Canada	V8T 5G1