Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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 placebo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sophiris Bio Corp

Criteria

Inclusion Criteria:

• Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months

• 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:

• 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