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

Benign Prostatic Hyperplasia Clinical Trial

— PLUS-1  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966614
• Other study ID #: PRX302-3-01
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2013
• Last updated: April 26, 2017
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Sophiris Bio Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• PRX302
Single intraprostatic bilateral injection at a dose of 0.6 µg/g

Other:
• Placebo
Single intraprostatic bilateral injection of vehicle only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sophiris Bio Corp

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.	Week 52
Secondary	Efficacy	Qmax change from baseline over 52 weeks.	Week 52
Secondary	Efficacy	IPSS total score change from baseline at each individual post-baseline timepoint.	Week 52
Secondary	Efficacy	Qmax change from baseline at each individual post-baseline timepoint.	Week 52
Secondary	Efficacy	IPSS "responders" at each individual post-baseline timepoint.	Week 52
Secondary	Efficacy	Qmax "responders" at each individual post-baseline timepoint.	Week 52
Secondary	Efficacy	Proportion of patients who receive rescue therapy.	Week 52
Secondary	Efficacy	Time to onset of rescue therapy.	Week 52
Secondary	Efficacy	Incidence rate for episodes of urinary retention.	Week 52
Secondary	Efficacy	Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.	Week 52
Secondary	Efficacy	Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.	Week 52
Secondary	Safety	Treatment-emergent adverse events (TEAEs).	Week 52
Secondary	Safety	Episodes of acute urinary retention as determined by the independent Adjudication Panel.	Week 52
Secondary	Safety	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).	Week 52
Secondary	Safety	Physical examinations.	Week 52
Secondary	Safety	Vital signs.	Week 52
Secondary	Safety	Electrocardiograms (ECGs).	Week 6
Secondary	Safety	Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.	Week 52
Secondary	Safety	Measurement of anti-PRX302 antibodies (APA).	Week 52
Secondary	Safety	Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.	Week 52