NCT01454349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

1.5 years

First QC Date

September 27, 2011

Last Update Submit

August 19, 2013

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasiaBPHEnlarged prostateLower urinary tract symptoms (LUTS)

Outcome Measures

Primary Outcomes (2)

  • Safety

    Safety of PRX302

    Month 3

  • Tolerability

    Tolerability of PRX302

    Month 3

Secondary Outcomes (7)

  • Efficacy

    Month 3

  • Efficacy

    Month 12

  • Pharmacokinetics

    Day 1

  • Safety

    Month 12

  • Tolerability

    Month 12

  • +2 more secondary outcomes

Study Arms (2)

PRX302

EXPERIMENTAL
Drug: PRX302

Inactive substance

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PRX302DRUG

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

PRX302
PlaceboDRUG

Single intraprostatic injection of matching placebo

Inactive substance

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

South Orange County Medical Research Center

Laguna Hills, California, 92653, United States

Location

Atlantic Urology Medical Group

Long Beach, California, 90806, United States

Location

California Professional Research

Newport Beach, California, 92660, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

TriState Urological Services

Cincinnatti, Ohio, 45212, United States

Location

Urologic Consultants of SE Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Research Across America

Carrollton, Texas, 75010, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Interventions

PRX302

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard C. Yocum, MD

    Sophiris Bio Corp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2011

First Posted

October 19, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2013

Study Completion

August 1, 2013

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations

US(15)