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

Completed · Phase 3 · Has a placebo group

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT01966614

Run by

Sophiris Bio Corp

People needed

479

Starts

2013-10-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-27

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Tarzana, California, United States
• Study site — Denver, Colorado, United States
• Study site — Middlebury, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — Pompano Beach, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Springfield, Illinois, United States
• Study site — Jeffersonville, Indiana, United States
• Study site — West Des Moines, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Greenbelt, Maryland, United States
• Study site — Towson, Maryland, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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