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NCT01454349 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01454349
Other study ID # PRX302-2-06
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 27, 2011
Last updated August 19, 2013
Start date September 2011
Est. completion date August 2013

Study information
Verified date August 2013
Source Sophiris Bio Corp
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PRX302
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
• Placebo
Single intraprostatic injection of matching placebo

Locations
Country Name City State
United States University of Colorado Denver Aurora Colorado
United States South Florida Medical Research Aventura Florida
United States Urologic Consultants of SE Pennsylvania Bala Cynwyd Pennsylvania
United States Research Across America Carrollton Texas
United States Northwestern University Chicago Illinois
United States TriState Urological Services Cincinnatti Ohio
United States UT Southwestern Medical Center Dallas Texas
United States Accumed Research Associates Garden City New York
United States South Orange County Medical Research Center Laguna Hills California
United States Atlantic Urology Medical Group Long Beach California
United States Carolina Urologic Research Center Myrtle Beach South Carolina
United States University Urology Associates New York New York
United States California Professional Research Newport Beach California
United States Premier Medical Group of the Hudson Valley Poughkeepsie New York
United States The Iowa Clinic West Des Moines Iowa

Sponsors (1)
Lead Sponsor Collaborator
Sophiris Bio Corp

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Safety of PRX302 Month 3 No
Primary Tolerability Tolerability of PRX302 Month 3 No
Secondary Efficacy Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS) Month 3 No
Secondary Efficacy Efficacy of PRX302 assessed by Qmax Month 12 No
Secondary Pharmacokinetics Pharmacokinetics (PK) measurements of PRX302 Day 1 No
Secondary Safety Safety of PRX302 Month 12 No
Secondary Tolerability Tolerability of PRX302 Month 12 No
Secondary Efficacy Efficacy of PRX302 assessed by uroflowmetry (Qmax) Month 3 No
Secondary Efficacy Efficacy of PRX302 assessed by IPSS Month 12 No
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