Overview

This trial has been completed.

Condition benign prostatic hyperplasia
Treatments prx302, placebo
Phase phase 3
Sponsor Sophiris Bio Corp
Start date October 2013
End date December 2015
Trial size 440 participants
Trial identifier NCT01966614, PRX302-3-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PRX302 injection
prx302 topsalysin
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
(Placebo Comparator)
Placebo (Vehicle-only injection)
placebo Vehicle-only
Single intraprostatic bilateral injection of vehicle only

Primary Outcomes

Measure
Efficacy
time frame: Week 52

Secondary Outcomes

Measure
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Efficacy
time frame: Week 52
Safety
time frame: Week 52
Safety
time frame: Week 52
Safety
time frame: Week 52
Safety
time frame: Week 52
Safety
time frame: Week 52
Safety
time frame: Week 6
Safety
time frame: Week 52
Safety
time frame: Week 52
Safety
time frame: Week 52

Eligibility Criteria

Male participants at least 50 years old.

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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sophiris Bio Corp.