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

August 19, 2013 updated by: Sophiris Bio Corp

A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • South Orange County Medical Research Center
      • Long Beach, California, United States, 90806
        • Atlantic Urology Medical Group
      • Newport Beach, California, United States, 92660
        • California Professional Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • New York, New York, United States, 10016
        • University Urology Associates
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
    • Ohio
      • Cincinnatti, Ohio, United States, 45212
        • TriState Urological Services
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of SE Pennsylvania
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • Carrollton, Texas, United States, 75010
        • Research Across America
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRX302
Drug: PRX302
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
Placebo Comparator: Inactive substance
Drug: Placebo
Single intraprostatic injection of matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Month 3
Safety of PRX302
Month 3
Tolerability
Time Frame: Month 3
Tolerability of PRX302
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Month 3
Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
Month 3
Efficacy
Time Frame: Month 12
Efficacy of PRX302 assessed by Qmax
Month 12
Pharmacokinetics
Time Frame: Day 1
Pharmacokinetics (PK) measurements of PRX302
Day 1
Safety
Time Frame: Month 12
Safety of PRX302
Month 12
Tolerability
Time Frame: Month 12
Tolerability of PRX302
Month 12
Efficacy
Time Frame: Month 3
Efficacy of PRX302 assessed by uroflowmetry (Qmax)
Month 3
Efficacy
Time Frame: Month 12
Efficacy of PRX302 assessed by IPSS
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophiris Bio Corp

Investigators

  • Study Director: Richard C. Yocum, MD, Sophiris Bio Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 14, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRX302-2-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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