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

A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01454349

Enrollment

Registered

2011-10-19

Start date

2011-09-30

Completion date

2013-08-31

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)

Brief 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.

Interventions

DRUGPRX302

Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL

DRUGPlacebo

Single intraprostatic injection of matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	Month 3	Safety of PRX302
Tolerability	Month 3	Tolerability of PRX302

Secondary

Measure	Time frame	Description
Efficacy	Month 3	Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
Pharmacokinetics	Day 1	Pharmacokinetics (PK) measurements of PRX302
Safety	Month 12	Safety of PRX302
Tolerability	Month 12	Tolerability of PRX302

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026