Clinical Trial: Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled Phase II Study of Transperineal Intraprostatic Injection of PRX302 for the Treatment of Benign Prostatic Hyperplasia

Brief Summary: The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).

Detailed Summary: This is a randomized, double-blinded, placebo-controlled study of transperineal intraprostatic injection of PRX302 under sonographic guidance. Subjects will be randomly assigned to the two treatment groups in a ratio of 2:1 between PRX302 and Placebo, stratified by prostate size and baseline IPSS.
Sponsor: Sophiris Bio Corp

Current Primary Outcome: Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline) [ Time Frame: 3 months post-treatment ]

Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.


Original Primary Outcome: To determine efficacy of PRX302 as measured by a change from baseline in International Prostate Symptom (IPSS) Score at 3, 6 and 12 months post-treatment when compared to placebo [ Time Frame: 3, 6 and 12 months post-treatment ]

Current Secondary Outcome: Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline) [ Time Frame: 3 months after treatment ]

A printout of uroflowmetry was provided to a central, blinded, independent reviewer for determination of the Qmax values to be used for evaluation of efficacy. The central, independent, blinded reviewer determined the Qmax from over-reads of the uroflowmetry printouts, applying the 2-second rule to reduce variability and increase the accuracy.


Original Secondary Outcome:

  • To compare efficacy of PRX302 as assessed by a change from baseline in Quality of Life, maximum urine flow rate (Qmax), and Post-void residual urine volume (PVR), at 3, 6 and 12 months when compared to placebo [ Time Frame: 3, 6 and 12 months post treatment ]
  • Parameters for assessment of safety and tolerability of PRX302 will include adverse events, including Serious Adverse Events(SAEs), physical exam, vital signs, ECG, clinical lab tests, and the International index for erectile function (IIEF) [ Time Frame: 12 months post treatment ]


Information By: Sophiris Bio Corp

Dates:
Date Received: April 27, 2009
Date Started: January 2009
Date Completion:
Last Updated: August 19, 2013
Last Verified: August 2013