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Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH (PLUS-1)

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: NCT01966614
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Sophiris Bio Corp

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE October 21, 2013
Last Update Posted Date April 27, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
Efficacy [ Time Frame: Week 52 ]
International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
  • Efficacy [ Time Frame: Week 52 ]
    Qmax change from baseline over 52 weeks.
  • Efficacy [ Time Frame: Week 52 ]
    IPSS total score change from baseline at each individual post-baseline timepoint.
  • Efficacy [ Time Frame: Week 52 ]
    Qmax change from baseline at each individual post-baseline timepoint.
  • Efficacy [ Time Frame: Week 52 ]
    IPSS "responders" at each individual post-baseline timepoint.
  • Efficacy [ Time Frame: Week 52 ]
    Qmax "responders" at each individual post-baseline timepoint.
  • Efficacy [ Time Frame: Week 52 ]
    Proportion of patients who receive rescue therapy.
  • Efficacy [ Time Frame: Week 52 ]
    Time to onset of rescue therapy.
  • Efficacy [ Time Frame: Week 52 ]
    Incidence rate for episodes of urinary retention.
  • Efficacy [ Time Frame: Week 52 ]
    Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.
  • Efficacy [ Time Frame: Week 52 ]
    Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.
  • Safety [ Time Frame: Week 52 ]
    Treatment-emergent adverse events (TEAEs).
  • Safety [ Time Frame: Week 52 ]
    Episodes of acute urinary retention as determined by the independent Adjudication Panel.
  • Safety [ Time Frame: Week 52 ]
    Assessment of sexual function for men who are sexually active using the International Index of Erectile Function - Erectile Function (IIEF-EF) and the Male Sexual Health Questionnaire© short form for ejaculatory dysfunction (MSHQ-EjD).
  • Safety [ Time Frame: Week 52 ]
    Physical examinations.
  • Safety [ Time Frame: Week 52 ]
    Vital signs.
  • Safety [ Time Frame: Week 6 ]
    Electrocardiograms (ECGs).
  • Safety [ Time Frame: Week 52 ]
    Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.
  • Safety [ Time Frame: Week 52 ]
    Measurement of anti-PRX302 antibodies (APA).
  • Safety [ Time Frame: Week 52 ]
    Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
Official Title  ICMJE Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: PRX302
    Single intraprostatic bilateral injection at a dose of 0.6 µg/g
    Other Name: topsalysin
  • Other: Placebo
    Single intraprostatic bilateral injection of vehicle only
    Other Name: Vehicle-only
Study Arms  ICMJE
  • Experimental: PRX302
    PRX302 injection
    Intervention: Drug: PRX302
  • Placebo Comparator: Placebo
    Placebo (Vehicle-only injection)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
479
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2013)
440
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥50 years
  • Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
  • IPSS ≥15
  • Maximum urine flow (Qmax) of 5 - 15 mL/sec
  • Prostate volume of 30 - 100 mL as determined by TRUS
  • Serum prostate-specific antigen (PSA) values <10 ng/mL
  • Post-void residual (PVR) <= 200 mL

Exclusion Criteria:

  • Inability to void ≥125 mL urine
  • Prior surgery/MIST for BPH
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01966614
Other Study ID Numbers  ICMJE PRX302-3-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sophiris Bio Corp
Study Sponsor  ICMJE Sophiris Bio Corp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard C Yocum, MD Sophiris Bio Corp
PRS Account Sophiris Bio Corp
Verification Date April 2017

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