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

Study Overview
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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.

Official Title
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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

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Lemuteporfin for injection
* Device: Transurethral drug delivery system
* Device: Transurethral light delivery system


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lemuteporfin for injection|nan|
|Device: Transurethral drug delivery system|nan|
|Device: Transurethral light delivery system|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia (BPH), Photodynamic Therapy (PDT), Lower Urinary Tract Symptoms (LUTS)