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.

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