Benign Prostatic HyperplasiaPhase 3PLUS-1NCT01966614
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
A Phase 3 study testing PRX302 in people with Benign Prostatic Hyperplasia, run by Sophiris Bio Corp at 76 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- PRX302
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 479 participants
- Where
- 76 sitesin 6 countries
- Study dates
- Oct 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
76 sites in 6 countries.
76 sites in 6 countries
United States45 sites
Study site
Albuquerque, New Mexico, 87109
Study site
Anchorage, Alaska, 99503
Study site
Aventura, Florida, 33180
Study site
Bala-Cynwyd, Pennsylvania, 19004
Study site
Baltimore, Maryland, 21204
Study site
Baltimore, Maryland, 21237
Study site
Brookline, Massachusetts, 02445
Study site
Bryn Mawr, Pennsylvania, 19010
Study site
Burien, Washington, 98166
Study site
Carrollton, Texas, 75010
Study site
Coeur d'Alene, Idaho, 83814
Study site
Concord, North Carolina, 28025
Study site
Coral Gables, Florida, 33134
Study site
Dallas, Texas, 75390
Study site
Denver, Colorado, 80220
Study site
Garden City, New York, 11530
Study site
Greenbelt, Maryland, 20770
Study site
Greer, South Carolina, 29650
Study site
Houston, Texas, 77030
Study site
Huntsville, Alabama, 35801
Study site
Jeffersonville, Indiana, 47130
Study site
Laguna Hills, California, 92653
Study site
Long Beach, California, 90806
Study site
Los Angeles, California, 90017
Study site
Meridian, Idaho, 83642
Study site
Middlebury, Connecticut, 06762
Study site
Missoula, Montana, 59808
Study site
Mount Laurel, New Jersey, 08054
Study site
Myrtle Beach, South Carolina, 29572
Study site
New York, New York, 10016
Study site
Newburgh, New York, 12550
Study site
Newport Beach, California, 92660
Study site
Pompano Beach, Florida, 33060
Study site
Poughkeepsie, New York, 12601
Study site
Raleigh, North Carolina, 27612
Study site
Salt Lake City, Utah, 84124
Study site
San Diego, California, 92120
Study site
San Diego, California, 92123
Study site
Springfield, Illinois, 62701
Study site
St. Petersburg, Florida, 33770
Study site
Tarzana, California, 91356
Study site
The Bronx, New York, 10457
Study site
Towson, Maryland, 21204
Study site
Wellington, Florida, 33449
Study site
West Des Moines, Iowa, 50266
Russia12 sites
Study site
Ivanovo, 153040
Study site
Moscow, 119991
Study site
Moscow, 125206
Study site
Rostov-on-Don, 344011
Study site
Saint Petersburg, 194044
Study site
Saint Petersburg, 194354
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197136
Study site
Saint Petersburg, 197374
Study site
Saint Petersburg, 198205
Study site
Saint Petersburg, 199178
Study site
Saratov, 410012
Ukraine9 sites
Study site
Chernihiv, 14034
Study site
Chernivtsi, 58000
Study site
Dnipropetrovsk, 49005
Study site
Kharkiv, 61000
Study site
Kyiv, 02125
Study site
Kyiv, 04053
Study site
Lviv, 79013
Study site
Lviv, 79059
Study site
Zaporizhzhya, 69600
Australia4 sites
Study site
Daw Park, South Australia, 5041
Study site
Mentone, Victoria, 3194
Study site
Parkville, Victoria, 3050
Study site
Woodville South, South Australia, 5011
Canada3 sites
Study site
Brampton, Ontario, L6T 4S5
Study site
Kitchener, Ontario, N2N 2B9
Study site
Oakville, Ontario, L6H 3P1
New Zealand3 sites
Study site
Christchurch, 8013
Study site
Tauranga, 3140
Study site
Whau Valley, Whangarei, 0145
About this study
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)
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
- Being tested
- PRX302, Placebo
- Keywords
- Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX302Drug
Also called topsalysin
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
PlaceboOther
Also called Vehicle-only
Single intraprostatic bilateral injection of vehicle only
| Study group | Role | What they receive |
|---|---|---|
| PRX302 | Experimental | PRX302 injection Receives: Drug: PRX302 |
| Placebo | Placebo comparator | Placebo (Vehicle-only injection) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
Measured: Week 52
Secondary outcomes (19)
Efficacy
Qmax change from baseline over 52 weeks.
Measured: Week 52
Efficacy
IPSS total score change from baseline at each individual post-baseline timepoint.
Measured: Week 52
Efficacy
Qmax change from baseline at each individual post-baseline timepoint.
Measured: Week 52
Efficacy
IPSS "responders" at each individual post-baseline timepoint.
Measured: Week 52
Efficacy
Qmax "responders" at each individual post-baseline timepoint.
Measured: Week 52
Efficacy
Proportion of patients who receive rescue therapy.
Measured: Week 52
Efficacy
Time to onset of rescue therapy.
Measured: Week 52
Efficacy
Incidence rate for episodes of urinary retention.
Measured: Week 52
Efficacy
Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.
Measured: Week 52
Efficacy
Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.
Measured: Week 52
Safety
Treatment-emergent adverse events (TEAEs).
Measured: Week 52
Safety
Episodes of acute urinary retention as determined by the independent Adjudication Panel.
Measured: Week 52
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).
Measured: Week 52
Safety
Physical examinations.
Measured: Week 52
Safety
Vital signs.
Measured: Week 52
Safety
Electrocardiograms (ECGs).
Measured: Week 6
Safety
Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.
Measured: Week 52
Safety
Measurement of anti-PRX302 antibodies (APA).
Measured: Week 52
Safety
Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophiris Bio Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard C Yocum, MD, Study director, Sophiris Bio Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966614
- Sponsor's protocol ID
- PRX302-3-01
- Acronym
- PLUS-1
- Status last verified
- Apr 2017
- First submitted
- 14 Oct 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01966614
- Acronym / sponsor ID
- PLUS-1 / PRX302-3-01
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Sophiris Bio CorpIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX302 | Experimental | Drug: PRX302PRX302 injection |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (Vehicle-only injection) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX302Also: topsalysinSingle intraprostatic bilateral injection at a dose of 0.6 µg/g | Drug | PRX302 |
| PlaceboAlso: Vehicle-onlySingle intraprostatic bilateral injection of vehicle only | Other | Placebo |
Primary outcome
Efficacy
Time frame: Week 52
International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
19 secondary outcomes
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Efficacy
Time frame: Week 52
Safety
Time frame: Week 52
Safety
Time frame: Week 52
Safety
Time frame: Week 52
Safety
Time frame: Week 52
Safety
Time frame: Week 52
Safety
Time frame: Week 6
Safety
Time frame: Week 52
Safety
Time frame: Week 52
Safety
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Yocum, MD study director
Sophiris Bio Corp
76 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRX302 in people with Benign Prostatic Hyperplasia, run by Sophiris Bio Corp at 76 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Russia, Ukraine, Australia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.