Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
- Registration Number
- NCT01966614
- Lead Sponsor
- Sophiris Bio Corp
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 479
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (Vehicle-only injection) PRX302 PRX302 PRX302 injection
- Primary Outcome Measures
Name Time Method Efficacy Week 52 International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
- Secondary Outcome Measures
Name Time Method Safety Week 52 Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
Efficacy Week 52 Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.