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

Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01966614

Acronym

PLUS-1

Enrollment

479

Registered

2013-10-21

Start date

2013-10-31

Completion date

2015-12-31

Last updated

2017-04-27

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 and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.

Interventions

DRUGPRX302

Single intraprostatic bilateral injection at a dose of 0.6 µg/g

OTHERPlacebo

Single intraprostatic bilateral injection of vehicle only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy	Week 52	International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.

Secondary

Measure	Time frame	Description
Efficacy	Week 52	Qmax change from baseline over 52 weeks.
Safety	Week 52	Treatment-emergent adverse events (TEAEs).

Countries

Australia, Canada, New Zealand, Russia, Ukraine, United States

Outcome results

None listed

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