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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sophiris Bio Corp

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