Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

Study Overview
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Brief Summary
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This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.

Official Title
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Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart

Conditions
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Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms (LUTS), LUTS

Intervention / Treatment
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* Drug: NX-1207


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male aged 45 or older. Sign an informed consent form. Be in good health. Received NX-1207 in a previous completed study (other than NX02-0020) or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit. Have Prostate Gland Volume ≥ 25 mL (25 g). Exclusion Criteria: Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection Post-void residual urine volume > 200 mL Presence of a symptomatic median lobe of the prostate History of use of self-catheterization for urinary retention. Urinary retention in the previous 12 months. Prostatitis Urinary tract infection more than once in the past 12 months Prostate or bladder cancer. Prostate-Specific Antigen (PSA) ≥ 10 ng/mL Poorly controlled diabetes History or evidence of illness or condition that may interfere with study or endanger subject Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days Use of specific prescribed medications that may interfere with study or endanger subject

Ages Eligible for Study
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Minimum Age: 45 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Injection of NX-1207<br>Intraprostatic injection of 2.5 mg NX-1207 | Drug: NX-1207<br>* 2.5 mg NX-1207 in 10 mL saline vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG). | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic Improvement | Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe). | 90 days | 
| Prostate Volume Change | Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography | 90 days | 
| Change in Urinary Peak Flow | Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry). | 90 days. | 
| Symptomatic Improvement | Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days. | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostatic hyperplasia, BPH, Lower urinary tract symptoms, LUTS, LUTS secondary to BPH, LUTS/BPH, Benign prostatic obstruction (BPO), BPO, Bladder outlet obstruction, BOO