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Completed

NCT Number: NCT01966614

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Daw Park, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRX302

Drug

Single intraprostatic bilateral injection at a dose of 0.6 µg/g

Other names: topsalysin

Placebo

Other

Single intraprostatic bilateral injection of vehicle only

Other names: Vehicle-only

Primary outcomes

  1. Efficacy

    Time frame: Week 52

    International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sophiris Bio Corp

Industry

Registry information

Official study 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)

Acronym: PLUS-1

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2013
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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