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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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)
Secondary ID [1] 0 0
PRX302-3-01
Universal Trial Number (UTN)
Trial acronym
PLUS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy - International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Efficacy - Qmax change from baseline over 52 weeks.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Efficacy - IPSS total score change from baseline at each individual post-baseline timepoint.
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Efficacy - Qmax change from baseline at each individual post-baseline timepoint.
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Efficacy - IPSS "responders" at each individual post-baseline timepoint.
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Efficacy - Qmax "responders" at each individual post-baseline timepoint.
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Efficacy - Proportion of patients who receive rescue therapy.
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Efficacy - Time to onset of rescue therapy.
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Efficacy - Incidence rate for episodes of urinary retention.
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Efficacy - Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Efficacy - Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Safety - Treatment-emergent adverse events (TEAEs).
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Safety - Episodes of acute urinary retention as determined by the independent Adjudication Panel.
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
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).
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Safety - Physical examinations.
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Safety - Vital signs.
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Safety - Electrocardiograms (ECGs).
Timepoint [16] 0 0
Week 6
Secondary outcome [17] 0 0
Safety - Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Safety - Measurement of anti-PRX302 antibodies (APA).
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Safety - Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
Timepoint [19] 0 0
Week 52

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
Minimum age
50 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Daw Park
Recruitment hospital [2] 0 0
- Woodville South
Recruitment hospital [3] 0 0
- Mentone
Recruitment hospital [4] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
5041 - Daw Park
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3194 - Mentone
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
New Zealand
State/province [24] 0 0
Whangarei
Country [25] 0 0
New Zealand
State/province [25] 0 0
Christchurch
Country [26] 0 0
New Zealand
State/province [26] 0 0
Tauranga
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Ivanovo
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Rostov-on-Don
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Saratov
Country [31] 0 0
Russian Federation
State/province [31] 0 0
St. Petersburg
Country [32] 0 0
Ukraine
State/province [32] 0 0
Chernigiv
Country [33] 0 0
Ukraine
State/province [33] 0 0
Chernovtsy
Country [34] 0 0
Ukraine
State/province [34] 0 0
Dnipropetrovsk
Country [35] 0 0
Ukraine
State/province [35] 0 0
Kharkiv
Country [36] 0 0
Ukraine
State/province [36] 0 0
Kyiv
Country [37] 0 0
Ukraine
State/province [37] 0 0
Lviv
Country [38] 0 0
Ukraine
State/province [38] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sophiris Bio Corp
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01966614
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard C Yocum, MD
Address 0 0
Sophiris Bio Corp
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications