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Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH (PLUS-1)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PRX302
Placebo
Sponsored by
Sophiris Bio Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRX302

Placebo

Arm Description

PRX302 injection

Placebo (Vehicle-only injection)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2013
Last Updated
April 26, 2017
Sponsor
Sophiris Bio Corp
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1. Study Identification

Unique Protocol Identification Number
NCT01966614
Brief Title
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sophiris Bio Corp

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
479 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRX302
Arm Type
Experimental
Arm Description
PRX302 injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Vehicle-only injection)
Intervention Type
Drug
Intervention Name(s)
PRX302
Other Intervention Name(s)
topsalysin
Intervention Description
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle-only
Intervention Description
Single intraprostatic bilateral injection of vehicle only
Primary Outcome Measure Information:
Title
Efficacy
Description
International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Efficacy
Description
Qmax change from baseline over 52 weeks.
Time Frame
Week 52
Title
Efficacy
Description
IPSS total score change from baseline at each individual post-baseline timepoint.
Time Frame
Week 52
Title
Efficacy
Description
Qmax change from baseline at each individual post-baseline timepoint.
Time Frame
Week 52
Title
Efficacy
Description
IPSS "responders" at each individual post-baseline timepoint.
Time Frame
Week 52
Title
Efficacy
Description
Qmax "responders" at each individual post-baseline timepoint.
Time Frame
Week 52
Title
Efficacy
Description
Proportion of patients who receive rescue therapy.
Time Frame
Week 52
Title
Efficacy
Description
Time to onset of rescue therapy.
Time Frame
Week 52
Title
Efficacy
Description
Incidence rate for episodes of urinary retention.
Time Frame
Week 52
Title
Efficacy
Description
Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.
Time Frame
Week 52
Title
Efficacy
Description
Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.
Time Frame
Week 52
Title
Safety
Description
Treatment-emergent adverse events (TEAEs).
Time Frame
Week 52
Title
Safety
Description
Episodes of acute urinary retention as determined by the independent Adjudication Panel.
Time Frame
Week 52
Title
Safety
Description
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).
Time Frame
Week 52
Title
Safety
Description
Physical examinations.
Time Frame
Week 52
Title
Safety
Description
Vital signs.
Time Frame
Week 52
Title
Safety
Description
Electrocardiograms (ECGs).
Time Frame
Week 6
Title
Safety
Description
Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.
Time Frame
Week 52
Title
Safety
Description
Measurement of anti-PRX302 antibodies (APA).
Time Frame
Week 52
Title
Safety
Description
Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
Time Frame
Week 52

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C Yocum, MD
Organizational Affiliation
Sophiris Bio Corp
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
The Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Mentone
State/Province
Victoria
ZIP/Postal Code
3194
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
City
Whau Valley
State/Province
Whangarei
ZIP/Postal Code
0145
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
City
Tauranga
ZIP/Postal Code
3140
Country
New Zealand
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125206
Country
Russian Federation
City
Rostov-on-Don
ZIP/Postal Code
344011
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197136
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197374
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
199178
Country
Russian Federation
City
Chernigiv
ZIP/Postal Code
14034
Country
Ukraine
City
Chernovtsy
ZIP/Postal Code
58000
Country
Ukraine
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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