Benign Prostatic HyperplasiaPhase 1/2NCT01454349
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
A Phase 1/2 study testing PRX302 in people with Benign Prostatic Hyperplasia, run by Sophiris Bio Corp at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, 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
- 40 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2011to Aug 2013
- Phase
- Phase 1/2
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Colorado Denver
Aurora, Colorado, 80045
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of SE Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Research Across America
Carrollton, Texas, 75010
Northwestern University
Chicago, Illinois, 60611
TriState Urological Services
Cincinnatti, Ohio, 45212
UT Southwestern Medical Center
Dallas, Texas, 75390
Accumed Research Associates
Garden City, New York, 11530
South Orange County Medical Research Center
Laguna Hills, California, 92653
Atlantic Urology Medical Group
Long Beach, California, 90806
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
University Urology Associates
New York, New York, 10016
California Professional Research
Newport Beach, California, 92660
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
The Iowa Clinic
West Des Moines, Iowa, 50266
About this study
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)
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.
- 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
Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
PlaceboDrug
Single intraprostatic injection of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| PRX302 | Experimental | Not described Receives: Drug: PRX302 |
| Inactive substance | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety of PRX302
Measured: Month 3
Tolerability
Tolerability of PRX302
Measured: Month 3
Secondary outcomes (7)
Efficacy
Efficacy of PRX302 assessed by International Prostate Symptom Score (IPSS)
Measured: Month 3
Efficacy
Efficacy of PRX302 assessed by Qmax
Measured: Month 12
Pharmacokinetics
Pharmacokinetics (PK) measurements of PRX302
Measured: Day 1
Safety
Safety of PRX302
Measured: Month 12
Tolerability
Tolerability of PRX302
Measured: Month 12
Efficacy
Efficacy of PRX302 assessed by uroflowmetry (Qmax)
Measured: Month 3
Efficacy
Efficacy of PRX302 assessed by IPSS
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionAug 2013
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT01454349
- Sponsor's protocol ID
- PRX302-2-06
- Status last verified
- Aug 2013
- First submitted
- 27 Sep 2011
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01454349
- Acronym / sponsor ID
- PRX302-2-06
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign prostatic hyperplasia, BPH, Enlarged prostate, Lower urinary tract symptoms (LUTS)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sophiris Bio CorpIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Oct 2011 (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, tolerability 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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX302 | Experimental | Drug: PRX302 |
| Inactive substance | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| PRX302Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL | Drug | PRX302 |
| PlaceboSingle intraprostatic injection of matching placebo | Drug | Inactive substance |
Primary outcome
Safety
Time frame: Month 3
Safety of PRX302
Tolerability
Time frame: Month 3
Tolerability of PRX302
7 secondary outcomes
Efficacy
Time frame: Month 3
Efficacy
Time frame: Month 12
Pharmacokinetics
Time frame: Day 1
Safety
Time frame: Month 12
Tolerability
Time frame: Month 12
Efficacy
Time frame: Month 3
Efficacy
Time frame: Month 12
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 21 Aug 2013.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PRX302 in people with Benign Prostatic Hyperplasia, run by Sophiris Bio Corp at 15 sites in United States.
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 8 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 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety (time frame: Month 3). The study lists 2 primary outcomes in all. 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 21 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.