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

Phase 1

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: PRX302; Drug: Placebo

• Registration Number: NCT01454349
• Lead Sponsor: Sophiris Bio Corp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-19
• Primary Completion: 2013-03
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRX302	PRX302	-
Inactive substance	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety	Month 3	Safety of PRX302
Tolerability	Month 3	Tolerability of PRX302

Secondary Outcome Measures

Name	Time	Method
Efficacy	Month 12	Efficacy of PRX302 assessed by IPSS
Pharmacokinetics	Day 1	Pharmacokinetics (PK) measurements of PRX302
Safety	Month 12	Safety of PRX302
Tolerability	Month 12	Tolerability of PRX302

Trial Locations

Locations (15)

Atlantic Urology Medical Group; 🇺🇸 Long Beach, California, United States

The Iowa Clinic; 🇺🇸 West Des Moines, Iowa, United States

Accumed Research Associates; 🇺🇸 Garden City, New York, United States

University Urology Associates; 🇺🇸 New York, New York, United States

Research Across America; 🇺🇸 Carrollton, Texas, United States

Urologic Consultants of SE Pennsylvania; 🇺🇸 Bala Cynwyd, Pennsylvania, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

South Orange County Medical Research Center; 🇺🇸 Laguna Hills, California, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Premier Medical Group of the Hudson Valley; 🇺🇸 Poughkeepsie, New York, United States

California Professional Research; 🇺🇸 Newport Beach, California, United States

TriState Urological Services; 🇺🇸 Cincinnatti, Ohio, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States