Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
NCT ID: NCT01454349
Last Updated: 2013-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2011-09-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PRX302
PRX302
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
Inactive substance
Placebo
Single intraprostatic injection of matching placebo
Interventions
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PRX302
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
Placebo
Single intraprostatic injection of matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
MALE
No
Sponsors
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Sophiris Bio Corp
INDUSTRY
Responsible Party
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Principal Investigators
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Richard C. Yocum, MD
Role: STUDY_DIRECTOR
Sophiris Bio Corp
Locations
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South Orange County Medical Research Center
Laguna Hills, California, United States
Atlantic Urology Medical Group
Long Beach, California, United States
California Professional Research
Newport Beach, California, United States
University of Colorado Denver
Aurora, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Northwestern University
Chicago, Illinois, 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
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
TriState Urological Services
Cincinnatti, Ohio, United States
Urologic Consultants of SE Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Research Across America
Carrollton, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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PRX302-2-06
Identifier Type: -
Identifier Source: org_study_id