Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety 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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Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: PRX302
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥50 years Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months IPSS ≥15 Maximum urine flow (Qmax) of 5 - 15 mL/sec Prostate volume of 30 - 100 mL as determined by TRUS Serum prostate-specific antigen (PSA) values <10 ng/mL Post-void residual (PVR) <= 200 mL Exclusion Criteria: Inability to void ≥125 mL urine Prior surgery/MIST for BPH 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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRX302<br>PRX302 injection | Drug: PRX302<br>* Single intraprostatic bilateral injection at a dose of 0.6 µg/g<br>* Other names: topsalysin;|
| Placebo Comparator: Placebo<br>Placebo (Vehicle-only injection) | Other: Placebo<br>* Single intraprostatic bilateral injection of vehicle only<br>* Other names: Vehicle-only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Qmax change from baseline over 52 weeks. | Week 52 | 
| Efficacy | IPSS total score change from baseline at each individual post-baseline timepoint. | Week 52 | 
| Efficacy | Qmax change from baseline at each individual post-baseline timepoint. | Week 52 | 
| Efficacy | IPSS responders at each individual post-baseline timepoint. | Week 52 | 
| Efficacy | Qmax responders at each individual post-baseline timepoint. | Week 52 | 
| Efficacy | Proportion of patients who receive rescue therapy. | Week 52 | 
| Efficacy | Time to onset of rescue therapy. | Week 52 | 
| Efficacy | Incidence rate for episodes of urinary retention. | Week 52 | 
| Efficacy | Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint. | Week 52 | 
| Efficacy | Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint. | Week 52 | 
| Safety | Treatment-emergent adverse events (TEAEs). | Week 52 | 
| Safety | Episodes of acute urinary retention as determined by the independent Adjudication Panel. | Week 52 | 
| Safety | Assessment of sexual function for men who are sexually active using the International Index of Erectile Function - Erectile Function (IIEF-EF) and the Male Sexual Health Questionnaire© short form for ejaculatory dysfunction (MSHQ-EjD). | Week 52 | 
| Safety | Physical examinations. | Week 52 | 
| Safety | Vital signs. | Week 52 | 
| Safety | Electrocardiograms (ECGs). | Week 6 | 
| Safety | Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis. | Week 52 | 
| Safety | Measurement of anti-PRX302 antibodies (APA). | Week 52 | 
| Safety | Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity. | Week 52 | 

 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)