Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH (PLUS-1)

April 26, 2017 updated by: Sophiris Bio Corp

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

479

Phase

  • Phase 3

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

  • Australia
    • South Australia
      • Daw Park, South Australia, Australia, 5041
      • Woodville South, South Australia, Australia, 5011
    • Victoria
      • Mentone, Victoria, Australia, 3194
      • Parkville, Victoria, Australia, 3050
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 4S5
      • Kitchener, Ontario, Canada, N2N 2B9
      • Oakville, Ontario, Canada, L6H 3P1
  • New Zealand
      • Christchurch, New Zealand, 8013
      • Tauranga, New Zealand, 3140
    • Whangarei
      • Whau Valley, Whangarei, New Zealand, 0145
  • Russian Federation
      • Ivanovo, Russian Federation, 153040
      • Moscow, Russian Federation, 119991
      • Moscow, Russian Federation, 125206
      • Rostov-on-Don, Russian Federation, 344011
      • Saratov, Russian Federation, 410012
      • St. Petersburg, Russian Federation, 197022
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 194044
      • St. Petersburg, Russian Federation, 197136
      • St. Petersburg, Russian Federation, 198205
      • St. Petersburg, Russian Federation, 197374
      • St. Petersburg, Russian Federation, 199178
  • Ukraine
      • Chernigiv, Ukraine, 14034
      • Chernovtsy, Ukraine, 58000
      • Dnipropetrovsk, Ukraine, 49005
      • Kharkiv, Ukraine, 61000
      • Kyiv, Ukraine, 04053
      • Kyiv, Ukraine, 02125
      • Lviv, Ukraine, 79013
      • Lviv, Ukraine, 79059
      • Zaporizhzhya, Ukraine, 69600
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • Alaska
      • Anchorage, Alaska, United States, 99503
    • California
      • Laguna Hills, California, United States, 92653
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90017
      • Newport Beach, California, United States, 92660
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92120
      • Tarzana, California, United States, 91356
    • Colorado
      • Denver, Colorado, United States, 80220
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
    • Florida
      • Aventura, Florida, United States, 33180
      • Coral Gables, Florida, United States, 33134
      • Pompano Beach, Florida, United States, 33060
      • Saint Petersburg, Florida, United States, 33770
      • Wellington, Florida, United States, 33449
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
      • Meridian, Idaho, United States, 83642
    • Illinois
      • Springfield, Illinois, United States, 62701
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Maryland
      • Baltimore, Maryland, United States, 21204
      • Baltimore, Maryland, United States, 21237
      • Greenbelt, Maryland, United States, 20770
      • Towson, Maryland, United States, 21204
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
    • Montana
      • Missoula, Montana, United States, 59808
    • New Jersey
      • Mount Laurel, New Jersey, United States, 08054
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
    • New York
      • Garden City, New York, United States, 11530
      • New York, New York, United States, 10016
      • Newburgh, New York, United States, 12550
      • Poughkeepsie, New York, United States, 12601
      • The Bronx, New York, United States, 10457
    • North Carolina
      • Concord, North Carolina, United States, 28025
      • Raleigh, North Carolina, United States, 27612
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Bryn Mawr, Pennsylvania, United States, 19010
    • South Carolina
      • Greer, South Carolina, United States, 29650
      • Myrtle Beach, South Carolina, United States, 29572
    • Texas
      • Carrollton, Texas, United States, 75010
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Washington
      • Burien, Washington, United States, 98166

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRX302
PRX302 injection
Drug: PRX302
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
Other Names:
  • topsalysin
Placebo Comparator: Placebo
Placebo (Vehicle-only injection)
Other: Placebo
Single intraprostatic bilateral injection of vehicle only
Other Names:
  • Vehicle-only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Week 52
International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Week 52
Qmax change from baseline over 52 weeks.
Week 52
Efficacy
Time Frame: Week 52
IPSS total score change from baseline at each individual post-baseline timepoint.
Week 52
Efficacy
Time Frame: Week 52
Qmax change from baseline at each individual post-baseline timepoint.
Week 52
Efficacy
Time Frame: Week 52
IPSS "responders" at each individual post-baseline timepoint.
Week 52
Efficacy
Time Frame: Week 52
Qmax "responders" at each individual post-baseline timepoint.
Week 52
Efficacy
Time Frame: Week 52
Proportion of patients who receive rescue therapy.
Week 52
Efficacy
Time Frame: Week 52
Time to onset of rescue therapy.
Week 52
Efficacy
Time Frame: Week 52
Incidence rate for episodes of urinary retention.
Week 52
Efficacy
Time Frame: Week 52
Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.
Week 52
Efficacy
Time Frame: Week 52
Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.
Week 52
Safety
Time Frame: Week 52
Treatment-emergent adverse events (TEAEs).
Week 52
Safety
Time Frame: Week 52
Episodes of acute urinary retention as determined by the independent Adjudication Panel.
Week 52
Safety
Time Frame: Week 52
Assessment of sexual function for men who are sexually active using the International Index of Erectile Function - Erectile Function (IIEF-EF) and the Male Sexual Health Questionnaire© short form for ejaculatory dysfunction (MSHQ-EjD).
Week 52
Safety
Time Frame: Week 52
Physical examinations.
Week 52
Safety
Time Frame: Week 52
Vital signs.
Week 52
Safety
Time Frame: Week 6
Electrocardiograms (ECGs).
Week 6
Safety
Time Frame: Week 52
Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.
Week 52
Safety
Time Frame: Week 52
Measurement of anti-PRX302 antibodies (APA).
Week 52
Safety
Time Frame: Week 52
Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
Week 52

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

October 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRX302-3-01

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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