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
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01454349
Ages eligible for Study
50 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
Written informed consent prior to enrollment in the study
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
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
All locations for NCT01454349
United States (15)
South Orange County Medical Research
Laguna Hills, California, United States, 92653
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
California Professional Research
Newport Beach, California, United States, 92660
University of Colorado
Aurora, Colorado, United States, 80045
South Florida Medical Research
Aventura, Florida, United States, 33180
Chicago, Illinois, United States, 60611
The Iowa Clinic
West Des Moines, Iowa, United States, 50266
Accumed Research Associates
Garden City, New York, United States, 11530
University Urology Associates
New York, New York, United States, 10016
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12601
The Urology Group
Cincinnatti, Ohio, United States, 45212
Urologic Consultants of SE Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19004
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Research Across America
Carrollton, Texas, United States, 75010
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
View full eligibility
Tris trial is registered with FDA with number: NCT01454349. The sponsor of the trial is Sophiris Bio Corp and it is looking for 40 volunteers for the current phase.
Official trial title: 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)
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