Clinical trial NCT01966614: Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
BPH
Enlarged prostate
Lower urinary tract symptoms (LUTS)
Lead sponsor: Sophiris Bio Corp
Sponsor class: INDUSTRY
First posted: 2013-10-21
Enrollment: 479
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Efficacy
timeFrame: Week 52
Secondary outcomes:
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Efficacy
timeFrame: Week 52
measure: Safety
timeFrame: Week 52
measure: Safety
timeFrame: Week 52
measure: Safety
timeFrame: Week 52
measure: Safety
timeFrame: Week 52
measure: Safety
timeFrame: Week 52
measure: Safety
timeFrame: Week 6
measure: Safety
timeFrame: Week 52
measure: Safety
timeFrame: Week 52
measure: Safety
timeFrame: Week 52
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Middlebury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Pompano Beach
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Coeur d'Alene
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Springfield
country: United States
state: Illinois
city: Jeffersonville
country: United States
state: Indiana
city: West Des Moines
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Greenbelt
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Brookline
country: United States
state: Massachusetts
city: Missoula
country: United States
state: Montana
city: Mount Laurel
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Garden City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Newburgh
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: The Bronx
country: United States
state: New York
city: Concord
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Bala-Cynwyd
country: United States
state: Pennsylvania
city: Bryn Mawr
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Carrollton
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burien
country: United States
state: Washington
city: Daw Park
country: Australia
state: South Australia
city: Woodville South
country: Australia
state: South Australia
city: Mentone
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Brampton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Whau Valley
country: New Zealand
state: Whangarei
city: Christchurch
country: New Zealand
city: Tauranga
country: New Zealand
city: Ivanovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Chernigiv
country: Ukraine
city: Chernovtsy
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Lviv
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Sophiris Bio Corp
name: Richard C Yocum, MD
role: STUDY_DIRECTOR
References: