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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
479

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sophiris Bio Corp

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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