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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sophiris Bio Corp
Sponsor:
Information provided by (Responsible Party):
Sophiris Bio Corp
ClinicalTrials.gov Identifier:
NCT01966614
First received: October 14, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: PRX302
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sophiris Bio Corp:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Qmax change from baseline over 52 weeks.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    IPSS total score change from baseline at each individual post-baseline timepoint.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Qmax change from baseline at each individual post-baseline timepoint.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    IPSS "responders" at each individual post-baseline timepoint.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Qmax "responders" at each individual post-baseline timepoint.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Proportion of patients who receive rescue therapy.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Time to onset of rescue therapy.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Incidence rate for episodes of urinary retention.

  • Efficacy [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.

  • Safety [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Treatment-emergent adverse events (TEAEs).

  • Safety [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Episodes of acute urinary retention as determined by the independent Adjudication Panel.

  • Safety [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Physical examinations.

  • Safety [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Vital signs.

  • Safety [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Electrocardiograms (ECGs).

  • Safety [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.

  • Safety [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Measurement of anti-PRX302 antibodies (APA).

  • Safety [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.


Estimated Enrollment: 440
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRX302
PRX302 injection
Drug: PRX302
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
Other Name: topsalysin
Placebo Comparator: Placebo
Placebo (Vehicle-only injection)
Other: Placebo
Single intraprostatic bilateral injection of vehicle only
Other Name: Vehicle-only

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966614

  Show 91 Study Locations
Sponsors and Collaborators
Sophiris Bio Corp
Investigators
Study Director: Richard C Yocum, MD Sophiris Bio Corp
  More Information

No publications provided

Responsible Party: Sophiris Bio Corp
ClinicalTrials.gov Identifier: NCT01966614     History of Changes
Other Study ID Numbers: PRX302-3-01
Study First Received: October 14, 2013
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014