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

This study has been terminated.
Sponsor:
Information provided by:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT00116571
First received: June 29, 2005
Last updated: October 2, 2006
Last verified: May 2006
History of Changes
  Purpose

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 Intervention Phase
Prostatic Hyperplasia
 Drug: Lemuteporfin for injection
Device: Transurethral drug delivery system
Device: Transurethral light delivery system
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by QLT Inc.:

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)

Estimated Enrollment: 180
Study Start Date: May 2005
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116571

Locations
United States, California
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
United States, Louisiana
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Maryland
Drs Werner, Murdock & Francis PA Urology Associates
Greenbelt, Maryland, United States, 20770
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
United States, New York
AccuMed Research Associates
Garden City, New York, United States, 11530
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
United States, Virginia
Devine Tidewater Urology
Virginia Beach, Virginia, United States, 23455
Canada, British Columbia
Can-Med Clinical Research Inc
Victoria, British Columbia, Canada, V8T 5G1
Sponsors and Collaborators
QLT Inc.
Investigators
Study Director: Graeme Boniface, PhD QLT Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00116571     History of Changes
Other Study ID Numbers: BPH 003
Study First Received: June 29, 2005
Last Updated: October 2, 2006
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by QLT Inc.:
Benign Prostatic Hyperplasia (BPH)
Photodynamic Therapy (PDT)
Lower Urinary Tract Symptoms (LUTS)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013