Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
Launched by SOPHIRIS BIO CORP · Oct 16, 2013
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
MALE
Eligibility criteria
- 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
About Sophiris Bio Corp
Sophiris Bio Corp. is a biotechnology company focused on developing innovative therapies for urologic diseases, particularly in the field of prostate health. With a commitment to addressing unmet medical needs, Sophiris leverages its proprietary technology platforms to advance novel treatments that enhance patient outcomes and improve quality of life. The company is dedicated to rigorous clinical research and collaboration, aiming to bring transformative solutions to the market for conditions such as benign prostatic hyperplasia (BPH) and prostate cancer. Through its robust pipeline and strategic partnerships, Sophiris Bio Corp. strives to lead advancements in urologic care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Albuquerque, New Mexico, United States
Dallas, Texas, United States
Long Beach, California, United States
Huntsville, Alabama, United States
San Diego, California, United States
Houston, Texas, United States
St. Petersburg, , Russian Federation
Greenbelt, Maryland, United States
New York, New York, United States
Dallas, Texas, United States
Long Beach, California, United States
San Diego, California, United States
Coeur D'alene, Idaho, United States
Los Angeles, California, United States
Baltimore, Maryland, United States
New York, New York, United States
Huntsville, Alabama, United States
Wellington, Florida, United States
Parkville, , Australia
Ivanovo, , Russian Federation
Towson, Maryland, United States
Albuquerque, New Mexico, United States
Parkville, Victoria, Australia
Pompano Beach, Florida, United States
Poughkeepsie, New York, United States
Laguna Hills, California, United States
Newport Beach, California, United States
Raleigh, North Carolina, United States
Aventura, Florida, United States
Meridian, Idaho, United States
Springfield, Illinois, United States
Baltimore, Maryland, United States
Bryn Mawr, Pennsylvania, United States
Coral Gables, Florida, United States
Carrollton, Texas, United States
Coeur D'alene, Idaho, United States
Salt Lake City, Utah, United States
Myrtle Beach, South Carolina, United States
Tarzana, California, United States
Saratov, , Russian Federation
Laguna Hills, California, United States
Lviv, , Ukraine
Denver, Colorado, United States
Garden City, New York, United States
Concord, North Carolina, United States
Moscow, , Russian Federation
Missoula, Montana, United States
Woodville South, South Australia, Australia
Burien, Washington, United States
Middlebury, Connecticut, United States
Kitchener, Ontario, Canada
Los Angeles, California, United States
Jeffersonville, Indiana, United States
Myrtle Beach, South Carolina, United States
Oakville, Ontario, Canada
Greer, South Carolina, United States
Mount Laurel, New Jersey, United States
Bala Cynwyd, Pennsylvania, United States
Brampton, Ontario, Canada
Wellington, Florida, United States
West Des Moines, Iowa, United States
Kyiv, , Ukraine
Newburgh, New York, United States
Dnipropetrovsk, , Ukraine
Brookline, Massachusetts, United States
Daw Park, South Australia, Australia
Zaporizhzhya, , Ukraine
Kharkiv, , Ukraine
Anchorage, Alaska, United States
Christchurch, Chatham Islands, New Zealand
Moscow, , Russian Federation
Saint Petersburg, Florida, United States
The Bronx, New York, United States
Mentone, Victoria, Australia
Whau Valley, Whangarei, New Zealand
Christchurch, , New Zealand
Tauranga, , New Zealand
Rostov On Don, , Russian Federation
Chernigiv, , Ukraine
Chernovtsy, , Ukraine
Patients applied
Trial Officials
Richard C Yocum, MD
Study Director
Sophiris Bio Corp
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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