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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01454349
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Sophiris Bio Corp

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: PRX302 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2011
Primary Completion Date : March 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PRX302 Drug: PRX302
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
Placebo Comparator: Inactive substance Drug: Placebo
Single intraprostatic injection of matching placebo



Primary Outcome Measures :
  1. Safety [ Time Frame: Month 3 ]
    Safety of PRX302

  2. Tolerability [ Time Frame: Month 3 ]
    Tolerability of PRX302


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Month 3 ]
    Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)

  2. Efficacy [ Time Frame: Month 12 ]
    Efficacy of PRX302 assessed by Qmax

  3. Pharmacokinetics [ Time Frame: Day 1 ]
    Pharmacokinetics (PK) measurements of PRX302

  4. Safety [ Time Frame: Month 12 ]
    Safety of PRX302

  5. Tolerability [ Time Frame: Month 12 ]
    Tolerability of PRX302

  6. Efficacy [ Time Frame: Month 3 ]
    Efficacy of PRX302 assessed by uroflowmetry (Qmax)

  7. Efficacy [ Time Frame: Month 12 ]
    Efficacy of PRX302 assessed by IPSS



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454349


Locations
United States, California
South Orange County Medical Research Center
Laguna Hills, California, United States, 92653
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
California Professional Research
Newport Beach, California, United States, 92660
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
The Iowa Clinic
West Des Moines, Iowa, United States, 50266
United States, New York
Accumed Research Associates
Garden City, New York, United States, 11530
University Urology Associates
New York, New York, United States, 10016
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12601
United States, Ohio
TriState Urological Services
Cincinnatti, Ohio, United States, 45212
United States, Pennsylvania
Urologic Consultants of SE Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19004
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Research Across America
Carrollton, Texas, United States, 75010
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Sophiris Bio Corp
Investigators
Study Director: Richard C. Yocum, MD Sophiris Bio Corp

Responsible Party: Sophiris Bio Corp
ClinicalTrials.gov Identifier: NCT01454349     History of Changes
Other Study ID Numbers: PRX302-2-06
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Sophiris Bio Corp:
Benign prostatic hyperplasia
BPH
Enlarged prostate
Lower urinary tract symptoms (LUTS)

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms