Clinical trial NCT01454349: Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
Official title: A Randomized Dose-Escalation, Multicenter Safety and Efficacy Study of a Single Transrectal Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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: 2011-10-19
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
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, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
* Written informed consent prior to enrollment in the study
* IPSS ≥12
* Prostate volume of 30 - 100 mL as determined by TRUS
* Maximum urine flow (Qmax) of 4 - 15 mL/sec
* Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors
* Unwilling or unable to undergo conventional surgical or available minimally invasive treatments
* Blood PSA values \<10 ng/mL

Exclusion Criteria:

* Inability to void at least 125 mL of urine
* PVR volume \>200 mL
* 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: Safety
timeFrame: Month 3
measure: Tolerability
timeFrame: Month 3
Secondary outcomes:
measure: Efficacy
timeFrame: Month 3
measure: Efficacy
timeFrame: Month 12
measure: Pharmacokinetics
timeFrame: Day 1
measure: Safety
timeFrame: Month 12
measure: Tolerability
timeFrame: Month 12
measure: Efficacy
timeFrame: Month 3
measure: Efficacy
timeFrame: Month 12
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: South Orange County Medical Research Center
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Newport Beach
country: United States
facility: California Professional Research
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Cincinnatti
country: United States
facility: TriState Urological Services
state: Ohio
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SE Pennsylvania
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Carrollton
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Sophiris Bio Corp
name: Richard C. Yocum, MD
role: STUDY_DIRECTOR
References: