Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.

Official Title
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A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: PRX302
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months Written informed consent prior to enrollment in the study IPSS ≥12 Prostate volume of 30 - 100 mL as determined by TRUS Maximum urine flow (Qmax) of 4 - 15 mL/sec Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors Unwilling or unable to undergo conventional surgical or available minimally invasive treatments Blood PSA values <10 ng/mL Exclusion Criteria: Inability to void at least 125 mL of urine PVR volume >200 mL Presence of or history of certain conditions that could interfere with study results or endanger subject Use of certain prescribed medications that could interfere with study results

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRX302<br> | Drug: PRX302<br>* Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL<br>|
| Placebo Comparator: Inactive substance<br> | Drug: Placebo<br>* Single intraprostatic injection of matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety of PRX302 | Month 3 | 
| Tolerability | Tolerability of PRX302 | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS) | Month 3 | 
| Efficacy | Efficacy of PRX302 assessed by Qmax | Month 12 | 
| Pharmacokinetics | Pharmacokinetics (PK) measurements of PRX302 | Day 1 | 
| Safety | Safety of PRX302 | Month 12 | 
| Tolerability | Tolerability of PRX302 | Month 12 | 
| Efficacy | Efficacy of PRX302 assessed by uroflowmetry (Qmax) | Month 3 | 
| Efficacy | Efficacy of PRX302 assessed by IPSS | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)