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Completed

NCT Number: NCT01454349

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

South Orange County Medical Research Center, Laguna Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRX302

Drug

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

Placebo

Drug

Single intraprostatic injection of matching placebo

Primary outcomes

  1. Safety

    Time frame: Month 3

    Safety of PRX302

  2. Tolerability

    Time frame: Month 3

    Tolerability of PRX302

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sophiris Bio Corp

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2011
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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