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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRX302
Placebo
Sponsored by
Sophiris Bio Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • South Orange County Medical Research Center
  • Atlantic Urology Medical Group
  • California Professional Research
  • University of Colorado Denver
  • South Florida Medical Research
  • Northwestern University
  • The Iowa Clinic
  • Accumed Research Associates
  • University Urology Associates
  • Premier Medical Group of the Hudson Valley
  • TriState Urological Services
  • Urologic Consultants of SE Pennsylvania
  • Carolina Urologic Research Center
  • Research Across America
  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRX302

Inactive substance

Arm Description

Outcomes

Primary Outcome Measures

Safety
Safety of PRX302
Tolerability
Tolerability of PRX302

Secondary Outcome Measures

Efficacy
Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
Efficacy
Efficacy of PRX302 assessed by Qmax
Pharmacokinetics
Pharmacokinetics (PK) measurements of PRX302
Safety
Safety of PRX302
Tolerability
Tolerability of PRX302
Efficacy
Efficacy of PRX302 assessed by uroflowmetry (Qmax)
Efficacy
Efficacy of PRX302 assessed by IPSS

Full Information

First Posted
September 27, 2011
Last Updated
August 19, 2013
Sponsor
Sophiris Bio Corp
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1. Study Identification

Unique Protocol Identification Number
NCT01454349
Brief Title
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sophiris Bio Corp

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRX302
Arm Type
Experimental
Arm Title
Inactive substance
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PRX302
Intervention Description
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intraprostatic injection of matching placebo
Primary Outcome Measure Information:
Title
Safety
Description
Safety of PRX302
Time Frame
Month 3
Title
Tolerability
Description
Tolerability of PRX302
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Efficacy
Description
Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
Time Frame
Month 3
Title
Efficacy
Description
Efficacy of PRX302 assessed by Qmax
Time Frame
Month 12
Title
Pharmacokinetics
Description
Pharmacokinetics (PK) measurements of PRX302
Time Frame
Day 1
Title
Safety
Description
Safety of PRX302
Time Frame
Month 12
Title
Tolerability
Description
Tolerability of PRX302
Time Frame
Month 12
Title
Efficacy
Description
Efficacy of PRX302 assessed by uroflowmetry (Qmax)
Time Frame
Month 3
Title
Efficacy
Description
Efficacy of PRX302 assessed by IPSS
Time Frame
Month 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C. Yocum, MD
Organizational Affiliation
Sophiris Bio Corp
Official's Role
Study Director
Facility Information:
Facility Name
South Orange County Medical Research Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Atlantic Urology Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
California Professional Research
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
TriState Urological Services
City
Cincinnatti
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Urologic Consultants of SE Pennsylvania
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Research Across America
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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