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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Efficacy
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Efficacy
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Efficacy
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Efficacy
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Efficacy
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Efficacy
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Efficacy
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Efficacy
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Efficacy
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Efficacy
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Safety
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Safety
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Safety
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Safety
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Safety
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Safety
Timepoint [16] 0 0
Week 6
Secondary outcome [17] 0 0
Safety
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Safety
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Safety
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
Sex
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
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
479
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
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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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01966614