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

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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

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: PRX302 Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 479 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Efficacy [ Time Frame: Week 52 ]
    International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: Week 52 ]
    Qmax change from baseline over 52 weeks.

  2. Efficacy [ Time Frame: Week 52 ]
    IPSS total score change from baseline at each individual post-baseline timepoint.

  3. Efficacy [ Time Frame: Week 52 ]
    Qmax change from baseline at each individual post-baseline timepoint.

  4. Efficacy [ Time Frame: Week 52 ]
    IPSS "responders" at each individual post-baseline timepoint.

  5. Efficacy [ Time Frame: Week 52 ]
    Qmax "responders" at each individual post-baseline timepoint.

  6. Efficacy [ Time Frame: Week 52 ]
    Proportion of patients who receive rescue therapy.

  7. Efficacy [ Time Frame: Week 52 ]
    Time to onset of rescue therapy.

  8. Efficacy [ Time Frame: Week 52 ]
    Incidence rate for episodes of urinary retention.

  9. 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.

  10. Efficacy [ Time Frame: Week 52 ]
    Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.

  11. Safety [ Time Frame: Week 52 ]
    Treatment-emergent adverse events (TEAEs).

  12. Safety [ Time Frame: Week 52 ]
    Episodes of acute urinary retention as determined by the independent Adjudication Panel.

  13. 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).

  14. Safety [ Time Frame: Week 52 ]
    Physical examinations.

  15. Safety [ Time Frame: Week 52 ]
    Vital signs.

  16. Safety [ Time Frame: Week 6 ]
    Electrocardiograms (ECGs).

  17. Safety [ Time Frame: Week 52 ]
    Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.

  18. Safety [ Time Frame: Week 52 ]
    Measurement of anti-PRX302 antibodies (APA).

  19. Safety [ Time Frame: Week 52 ]
    Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966614


  Show 76 Study Locations
Sponsors and Collaborators
Sophiris Bio Corp
Investigators
Study Director: Richard C Yocum, MD Sophiris Bio Corp

Responsible Party: Sophiris Bio Corp
ClinicalTrials.gov Identifier: NCT01966614     History of Changes
Other Study ID Numbers: PRX302-3-01
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms