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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sophiris Bio Corp
ClinicalTrials.gov Identifier:
NCT01454349
First received: September 27, 2011
Last updated: August 19, 2013
Last verified: August 2013

September 27, 2011
August 19, 2013
September 2011
March 2013   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Safety of PRX302
  • Tolerability [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Tolerability of PRX302
  • Safety [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Safety of PRX302 will be monitored during routine visits and assessed by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, Prostate-Specific Antigen (PSA), anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, International Index of Erectile Function - Erectile Function Domain (IIEF-EF), New York Heart Association Functional Classification and adverse events at Month 3 compared to baseline and placebo controls.
  • Tolerability [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Tolerability of PRX302 will be monitored during routine visits and assessed by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, Prostate-Specific Antigen (PSA), anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, International Index of Erectile Function - Erectile Function Domain (IIEF-EF), New York Heart Association Functional Classification and adverse events at Month 3 compared to baseline and placebo controls.
Complete list of historical versions of study NCT01454349 on ClinicalTrials.gov Archive Site
  • Efficacy [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
  • Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Efficacy of PRX302 assessed by Qmax
  • Pharmacokinetics [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Pharmacokinetics (PK) measurements of PRX302
  • Safety [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Safety of PRX302
  • Tolerability [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Tolerability of PRX302
  • Efficacy [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Efficacy of PRX302 assessed by uroflowmetry (Qmax)
  • Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Efficacy of PRX302 assessed by IPSS
  • Efficacy [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS), quality of life (QOL), uroflowmetry (Qmax), post-void residual (PVR) and prostate volume (PV) at Month 3 compared to baseline and placebo controls.
  • Efficacy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Longer term (12 months) efficacy of PRX302 assessed by IPSS, quality of life, uroflowmetry (Qmax), post-void residual (PVR) and prostate volume (PV) at Month 12 compared to baseline and placebo controls.
  • Pharmacokinetics [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Pharmacokinetics (PK) measurements of PRX302 will be assessed by taking serum (at baseline, 15 min, 1 hr, 2hr and 4hr post dose)and urine (at baseline, 30min, 1 hr, 2hr, 4hr and day 2) samples during the study. The levels of PRX302 will be compared to baseline and placebo controls.
  • Safety [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Longer term (12 months) safety of PRX302 assessed during routine visits by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, PSA, anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, IIEF-EF, New York Heart Association Functional Classification and adverse events at Month 12 compared to baseline and placebo controls.
  • Tolerability [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Longer term (12 months) tolerability of PRX302 assessed during routine visits by physical exam, 12-Lead ECG, vital signs, serum and urine analysis, PSA, anti-PRX302 antibodies, PRX302 hypersensitivity monitoring, IIEF-EF, New York Heart Association Functional Classification and adverse events at Month 12 compared to baseline and placebo controls.
Not Provided
Not Provided
 
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
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)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
  • Drug: PRX302
    Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
  • Drug: Placebo
    Single intraprostatic injection of matching placebo
  • Experimental: PRX302
    Intervention: Drug: PRX302
  • Placebo Comparator: Inactive substance
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2013
March 2013   (final data collection date for primary outcome measure)

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
Male
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01454349
PRX302-2-06
Yes
Sophiris Bio Corp
Sophiris Bio Corp
Not Provided
Study Director: Richard C. Yocum, MD Sophiris Bio Corp
Sophiris Bio Corp
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP