Prostatic HyperplasiaPhase 2NCT00116571
Photodynamic Therapy (PDT) for Lower Urinary Tract Symptoms (PLUS)
A Phase 2 study testing Lemuteporfin for injection, Transurethral drug delivery system and Transurethral light delivery system in people with Prostatic Hyperplasia, run by QLT Inc. at 9 sites in 2 countries.
Trial summary
The purpose of this study is to determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate. Photodynamic therapy (known as "PDT") is a treatment that uses light to make a drug work. This means the drug is "light-activated". Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Lemuteporfin for injection, Transurethral drug delivery system and Transurethral light delivery system
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 180 participants
- Where
- 9 sitesin 2 countries
- Study dates
- May 2005to Dec 2006
- Phase
- Phase 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 21 years of age and older.
- Subjects with LUTS due to BPH with AUA SI scores of 13 and over and Qmax between 5 and 15 mL/sec.
- Subjects with urethral treatment length of at least 25 mm.
Who cannot join
- Subjects who have had previous minimally invasive or surgical treatment for BPH.
- Subjects who have unsuitable prostate dimensions.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Duke University Medical Center
Durham, North Carolina, 27710
AccuMed Research Associates
Garden City, New York, 11530
Drs Werner, Murdock & Francis PA Urology Associates
Greenbelt, Maryland, 20770
Lawrenceville Urology
Lawrenceville, New Jersey, 08648
Urology San Antonio Research, PA
San Antonio, Texas, 78229
San Bernardino Urological Associates
San Bernardino, California, 92404
Regional Urology, LLC
Shreveport, Louisiana, 71106
Devine Tidewater Urology
Virginia Beach, Virginia, 23455
About this study
Official title: A Phase II Randomized, Sham-Controlled, Double-Blind, Dose-Finding Study to Assess the Efficacy and Safety of Transurethral Photodynamic Therapy With Lemuteporfin in Subjects With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
The purpose of this study is to determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate.
Photodynamic therapy (known as "PDT") is a treatment that uses light to make a drug work. This means the drug is "light-activated". Light-activated drugs do not work until a certain color of light shines on the drug. When the drug and the light combine, they react together to destroy tissue.
This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary symptoms go back to normal.
Read the detailed description
This is a multi-center, randomized, sham-controlled, double-blind, dose-finding study in parallel groups of subjects with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). All subjects will receive a fixed dose of lemuteporfin injected transurethrally into the prostate followed by transurethral application of either one of three active light doses or a sham light dose. Subjects will be followed for safety and efficacy for a minimum of three months to a maximum of 12 months. The primary study endpoint will be the change from baseline in AUA SI score at three months.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Lemuteporfin for injection, Transurethral drug delivery system, Transurethral light delivery system
- Keywords
- Benign Prostatic Hyperplasia (BPH), Photodynamic Therapy (PDT), 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.
Lemuteporfin for injectionDrug
Transurethral drug delivery systemDevice
Transurethral light delivery systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit
Secondary outcomes (5)
Responder rate
Change from baseline in Qmax
Change from baseline in post-void residual (PVR)
Shifts from baseline in subject responses to the BPH Quality of Life Impact Assessment
Safety outcomes: adverse events, clinical laboratory tests, vital signs, dysuria, and Male Sexual Health Questionnaire (MSHQ)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startMay 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- QLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Graeme Boniface, PhD, Study director, QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116571
- Sponsor's protocol ID
- BPH 003
- Status last verified
- May 2006
- First submitted
- 29 Jun 2005
- Last updated
- 3 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Sham-Controlled, Double-Blind, Dose-Finding Study to Assess the Efficacy and Safety of Transurethral Photodynamic Therapy With Lemuteporfin in Subjects With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00116571
- Acronym / sponsor ID
- BPH 003
- Conditions
- Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia (BPH), Photodynamic Therapy (PDT), Lower Urinary Tract Symptoms (LUTS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 180 participants
- Lead sponsor
- QLT Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Dec 2006
- First posted
- 30 Jun 2005 (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 determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate.
Photodynamic therapy (known as "PDT") is a treatment that uses light to make a drug work. This means the drug is "light-activated". Light-activated drugs do not work until a certain color of light shines on the drug. When the drug and the light combine, they react together to destroy tissue.
This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary symptoms go back to normal.
Detailed description
This is a multi-center, randomized, sham-controlled, double-blind, dose-finding study in parallel groups of subjects with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). All subjects will receive a fixed dose of lemuteporfin injected transurethrally into the prostate followed by transurethral application of either one of three active light doses or a sham light dose. Subjects will be followed for safety and efficacy for a minimum of three months to a maximum of 12 months. The primary study endpoint will be the change from baseline in AUA SI score at three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men 21 years of age and older.
- Subjects with LUTS due to BPH with AUA SI scores of 13 and over and Qmax between 5 and 15 mL/sec.
- Subjects with urethral treatment length of at least 25 mm.
Key exclusion criteria (2 listed)
- Subjects who have had previous minimally invasive or surgical treatment for BPH.
- Subjects who have unsuitable prostate dimensions.
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 |
|---|---|---|
| Lemuteporfin for injection | Drug | – |
| Transurethral drug delivery system | Device | – |
| Transurethral light delivery system | Device | – |
Primary outcome
The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit
5 secondary outcomes
Responder rate
Change from baseline in Qmax
Change from baseline in post-void residual (PVR)
Shifts from baseline in subject responses to the BPH Quality of Life Impact Assessment
Safety outcomes: adverse events, clinical laboratory tests, vital signs, dysuria, and Male Sexual Health Questionnaire (MSHQ)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2006.
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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.
Graeme Boniface, PhD study director
QLT Inc.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lemuteporfin for injection, Transurethral drug delivery system and Transurethral light delivery system in people with Prostatic Hyperplasia, run by QLT Inc. at 9 sites in 2 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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. 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 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 was stopped early. Results are not available in the source record.
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?
The change from baseline in American Urological Association Symptom Index (AUA SI) score at the Month 3 visit. 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 3 Oct 2006.