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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01966614
Registration number
NCT01966614
Ethics application status
Date submitted
14/10/2013
Date registered
21/10/2013
Date last updated
27/04/2017
Titles & IDs
Public title
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
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Scientific 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)
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Secondary ID [1]
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PRX302-3-01
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Universal Trial Number (UTN)
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Trial acronym
PLUS-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PRX302
Other interventions - Placebo
Experimental: PRX302 - PRX302 injection
Placebo Comparator: Placebo - Placebo (Vehicle-only injection)
Treatment: Drugs: PRX302
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
Other interventions: Placebo
Single intraprostatic bilateral injection of vehicle only
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy
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Assessment method [1]
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International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Efficacy
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Assessment method [1]
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Qmax change from baseline over 52 weeks.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Efficacy
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Assessment method [2]
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IPSS total score change from baseline at each individual post-baseline timepoint.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Efficacy
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Assessment method [3]
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Qmax change from baseline at each individual post-baseline timepoint.
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Efficacy
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Assessment method [4]
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IPSS "responders" at each individual post-baseline timepoint.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Efficacy
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Assessment method [5]
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Qmax "responders" at each individual post-baseline timepoint.
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Efficacy
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Assessment method [6]
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Proportion of patients who receive rescue therapy.
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Efficacy
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Assessment method [7]
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Time to onset of rescue therapy.
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Timepoint [7]
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Week 52
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Secondary outcome [8]
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Efficacy
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Assessment method [8]
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Incidence rate for episodes of urinary retention.
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Timepoint [8]
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Week 52
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Secondary outcome [9]
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Efficacy
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Assessment method [9]
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Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.
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Timepoint [9]
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Week 52
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Secondary outcome [10]
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Efficacy
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Assessment method [10]
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Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.
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Timepoint [10]
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Week 52
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Secondary outcome [11]
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Safety
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Assessment method [11]
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Treatment-emergent adverse events (TEAEs).
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Timepoint [11]
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Week 52
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Secondary outcome [12]
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Safety
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Assessment method [12]
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Episodes of acute urinary retention as determined by the independent Adjudication Panel.
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Timepoint [12]
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Week 52
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Secondary outcome [13]
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Safety
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Assessment method [13]
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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).
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Timepoint [13]
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Week 52
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Secondary outcome [14]
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Safety
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Assessment method [14]
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Physical examinations.
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Timepoint [14]
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Week 52
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Secondary outcome [15]
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Safety
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Assessment method [15]
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Vital signs.
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Timepoint [15]
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Week 52
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Secondary outcome [16]
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Safety
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Assessment method [16]
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Electrocardiograms (ECGs).
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Timepoint [16]
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Week 6
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Secondary outcome [17]
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Safety
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Assessment method [17]
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Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.
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Timepoint [17]
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Week 52
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Secondary outcome [18]
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Safety
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Assessment method [18]
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Measurement of anti-PRX302 antibodies (APA).
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Timepoint [18]
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Week 52
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Secondary outcome [19]
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Safety
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Assessment method [19]
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Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
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Timepoint [19]
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Week 52
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Eligibility
Key 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
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
479
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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- Daw Park
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Recruitment hospital [2]
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- Woodville South
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Recruitment hospital [3]
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- Mentone
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Recruitment hospital [4]
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- Parkville
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Recruitment postcode(s) [1]
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5041 - Daw Park
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment postcode(s) [3]
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3194 - Mentone
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Alaska
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Country [3]
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United States of America
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California
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Country [4]
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United States of America
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State/province [4]
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Colorado
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Country [5]
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United States of America
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Connecticut
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Country [6]
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United States of America
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Florida
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Country [7]
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United States of America
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Idaho
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Country [8]
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United States of America
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State/province [8]
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Illinois
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Country [9]
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United States of America
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State/province [9]
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Indiana
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Country [10]
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United States of America
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State/province [10]
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Iowa
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Country [11]
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United States of America
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State/province [11]
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Maryland
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Country [12]
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United States of America
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Massachusetts
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Country [13]
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United States of America
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Montana
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Country [14]
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United States of America
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State/province [14]
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New Jersey
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Country [15]
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United States of America
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State/province [15]
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New Mexico
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Country [16]
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United States of America
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State/province [16]
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New York
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Country [17]
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United States of America
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North Carolina
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United States of America
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State/province [18]
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Pennsylvania
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United States of America
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South Carolina
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Texas
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Utah
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Washington
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Canada
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Ontario
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New Zealand
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Whangarei
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New Zealand
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Christchurch
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New Zealand
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Tauranga
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Russian Federation
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Ivanovo
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Russian Federation
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State/province [28]
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Moscow
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Country [29]
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Russian Federation
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State/province [29]
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Rostov-on-Don
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Ukraine
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State/province [32]
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Chernigiv
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Ukraine
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State/province [33]
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Chernovtsy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Country [38]
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Ukraine
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State/province [38]
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Zaporizhzhya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sophiris Bio Corp
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01966614
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Richard C Yocum, MD
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Address
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Sophiris Bio Corp
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01966614
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