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

NCT01966614 | Completed Phase 3 DMC

• 1 other identifier: PRX302-3-01
• Study Type: interventional
• Target: 479
• Locations: 6 countries
• Sites: 76

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia; BPH; Enlarged prostate; Lower urinary tract symptoms (LUTS)

Outcome Measures

Primary Outcomes (1)

• Efficacy

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

  Week 52

Secondary Outcomes (19)

• Efficacy

  Week 52

• Efficacy

  Week 52

• Efficacy

  Week 52

• Efficacy

  Week 52

• Efficacy

  Week 52

Study Arms (2)

PRX302

EXPERIMENTAL

PRX302 injection

Drug: PRX302

Placebo

PLACEBO COMPARATOR

Placebo (Vehicle-only injection)

Other: Placebo

Interventions

PRX302 DRUG

Single intraprostatic bilateral injection at a dose of 0.6 µg/g

Also known as: topsalysin

PRX302

Placebo OTHER

Single intraprostatic bilateral injection of vehicle only

Also known as: Vehicle-only

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sophiris Bio Corp: lead

Study Sites (76)

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Huntsville, Alabama, 35801, United States

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Anchorage, Alaska, 99503, United States

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Laguna Hills, California, 92653, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90017, United States

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Newport Beach, California, 92660, United States

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San Diego, California, 92120, United States

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San Diego, California, 92123, United States

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Tarzana, California, 91356, United States

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Denver, Colorado, 80220, United States

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Middlebury, Connecticut, 06762, United States

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Aventura, Florida, 33180, United States

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Coral Gables, Florida, 33134, United States

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Pompano Beach, Florida, 33060, United States

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St. Petersburg, Florida, 33770, United States

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Wellington, Florida, 33449, United States

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Coeur d'Alene, Idaho, 83814, United States

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Meridian, Idaho, 83642, United States

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Springfield, Illinois, 62701, United States

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Jeffersonville, Indiana, 47130, United States

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West Des Moines, Iowa, 50266, United States

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Baltimore, Maryland, 21204, United States

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Baltimore, Maryland, 21237, United States

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Greenbelt, Maryland, 20770, United States

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Towson, Maryland, 21204, United States

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Brookline, Massachusetts, 02445, United States

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Missoula, Montana, 59808, United States

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Mount Laurel, New Jersey, 08054, United States

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Albuquerque, New Mexico, 87109, United States

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Garden City, New York, 11530, United States

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New York, New York, 10016, United States

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Newburgh, New York, 12550, United States

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Poughkeepsie, New York, 12601, United States

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The Bronx, New York, 10457, United States

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Concord, North Carolina, 28025, United States

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Raleigh, North Carolina, 27612, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Bryn Mawr, Pennsylvania, 19010, United States

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Greer, South Carolina, 29650, United States

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Myrtle Beach, South Carolina, 29572, United States

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Carrollton, Texas, 75010, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84124, United States

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Burien, Washington, 98166, United States

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Daw Park, South Australia, 5041, Australia

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Woodville South, South Australia, 5011, Australia

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Mentone, Victoria, 3194, Australia

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Parkville, Victoria, 3050, Australia

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Brampton, Ontario, L6T 4S5, Canada

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Kitchener, Ontario, N2N 2B9, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Whau Valley, Whangarei, 0145, New Zealand

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Christchurch, 8013, New Zealand

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Tauranga, 3140, New Zealand

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Ivanovo, 153040, Russia

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Moscow, 119991, Russia

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Moscow, 125206, Russia

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Rostov-on-Don, 344011, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197136, Russia

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Saint Petersburg, 197374, Russia

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Saint Petersburg, 198205, Russia

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Saint Petersburg, 199178, Russia

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Saratov, 410012, Russia

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Chernihiv, 14034, Ukraine

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Chernivtsi, 58000, Ukraine

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Dnipropetrovsk, 49005, Ukraine

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Kharkiv, 61000, Ukraine

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Kyiv, 02125, Ukraine

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Kyiv, 04053, Ukraine

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Lviv, 79013, Ukraine

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Lviv, 79059, Ukraine

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Zaporizhzhya, 69600, Ukraine

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MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

PRX302

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard C Yocum, MD

  Sophiris Bio Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 21, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

RU (12); AU (4); CA (3); NZ (3); UA (9); US (45)