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

Sophiris Bio Corp

Status and phase: Completed; Phase 2; Phase 1

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Placebo; Drug: PRX302

Study type: Interventional

Funder types: Industry

Identifiers

NCT01454349

PRX302-2-06

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

PRX302

Experimental group

Treatment:

Drug: PRX302

Inactive substance

Placebo Comparator group

Treatment:

Drug: Placebo