Benign Prostatic HyperplasiaPhase 2NCT00918034
Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
A Phase 2 study testing talaporfin sodium, Transurethral illumination with light emitting diodes and Placement in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Light Sciences Oncology at 8 sites in 2 countries.
Trial summary
This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- talaporfin sodium, Transurethral illumination with light emitting diodes and Placement
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 8 sitesin 2 countries
- Study dates
- May 2009to Feb 2011
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, aged 50 years or older with prior diagnosis of BPH;
- Patients may be eligible whether or not they are on medication for LUTS due to BPH.
- Patients who are candidates for interventional therapy;
- Patients who understand and have the ability to sign written informed consent prior to any study procedures and/or discontinuation of exclusionary medications;
- Patients with an International Prostate Symptom Score of ≥ 15 points;
- Patients with moderate to severe BPH (Bother Score ≥ 3);
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- Maximum urinary flow rate (Qmax) ≤ 15 mL/sec;
- Post void residual volume (PVR) ≤ 300 mL;
- Length of prostatic urethra ≥ 4.0 cm.
Who cannot join
- Patients with any previous minimally invasive or surgical intervention for BPH.
- Patients who are currently enrolled in or who have enrolled in another clinical trial for any disease within the past 30 days.
- Patients with an active urinary tract infection.
- Patients with a urethral stricture.
- Patients with interstitial cystitis.
- Patients with a predominant middle lobe obstruction.
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- Patients who have evidence or history of prostate or bladder cancer or carcinoma in situ of the bladder.
- Patients with an abnormal digital rectal exam suggestive of carcinoma of the prostate.
- Patients with an abnormal digital rectal exam suggestive of an indurated nodule.
- Patients with a PSA of > 10 ng/ml. If the PSA is 4-10 ng/ml, local standard of care should be pursued to ensure the possibility of prostate cancer is followed up and ruled out prior to, entry into the study.
- Patients who had a biopsy of the prostate within the past 6 weeks.
- Patients with bleeding diathesis.
- Patients with clinically significant renal or hepatic impairment.
- Patients with neurological conditions felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder.
- Patients who daily use a pad or device for incontinence.
- Patients who had an episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriches syndrome.
- Patient has an interest in future fertility.
- Patients with prolonged QT interval at baseline and/or who are currently taking medication that prolongs QT interval ("prolonged QT interval" defined as > 450 ms).
- Inadequate organ function as evidenced by the following: Platelet count <100,000/mm3; WBC <4,000/mm3; Neutrophils <1,800/mm3; Hemoglobin <10 g/dL; AST and ALT >3 x ULN; Creatinine >1.5 x ULN
- Known sensitivity to porphyrin-type drugs or known history of porphyria.
- Inability to avoid bright indoor lighting and sunlight during the first 72 hours after LS11 administration.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
New Zealand5 sites
Canterbury Urology Research Trust Hiatt Chambers St. George's Medical Centre
Christchurch
Roundhay Medical Centre
Nelson
Tauranga Urology Research, Ltd.
Tauranga
Wellington Urology Research Group Wakefield Urology
Wellington
Kensington Hospital Cardinal Points Specialist Centre
Whangarei
Australia3 sites
Royal Brisbane and Women's Hospital Center of Clinical Research
Herston
Bayside Urology
Mentone
Princess Alexandra Hospital
Wolloongabba, QLD 4102
About this study
Official title: A Phase 2 Study to Evaluate the Safety and Effectiveness of Using the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Who Are Candidates for Interventional Therapy
This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).
Read the detailed description
This is a phase 2 study to evaluate the safety and effectiveness of using light-activated talaporfin sodium in patients with LUTS due to BPH who are candidates for interventional therapy.
The eligible patient will undergo placement of a proprietary drug activator into the prostatic urethra. Following the placement of the drug activator, patients will receive talaporfin sodium at 1 mg/kg intravenously by slow push over 3-5 minutes. Fifteen minutes after injection a light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes.
SAE reporting will occur from the day of treatment (Day 0) through end of study (month 12), inclusive. Any SAE that is still ongoing at the end of the study will be followed until assessed as chronic, stable or resolved.
- Being tested
- talaporfin sodium, Transurethral illumination with light emitting diodes, Placement
- Keywords
- BPH, LUTS, talaporfin sodium
- 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.
talaporfin sodiumDrug
Also called LS11
LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)
Transurethral illumination with light emitting diodesDevice
A light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes
PlacementProcedure or surgery
Placement of device in prostate urethra
| Study group | Role | What they receive |
|---|---|---|
| LS11 (talaporfin sodium) | Experimental | Not described Receives: Drug: talaporfin sodium; Device: Transurethral illumination with light emitting diodes; Procedure: Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of light-activated talaporfin sodium by recording of Adverse Events; Preliminary effectiveness of light-activated talaporfin sodium by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2011
- Study completionFeb 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Light Sciences Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sy-Shi Wang, PhD, Study director, Light Sciences Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918034
- Sponsor's protocol ID
- LSO-OL012
- Status last verified
- Nov 2012
- First submitted
- 9 Jun 2009
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety and Effectiveness of Using the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Who Are Candidates for Interventional Therapy
- ClinicalTrials.gov ID
- NCT00918034
- Acronym / sponsor ID
- LSO-OL012
- Keywords
- BPH, LUTS, talaporfin sodium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Light Sciences OncologyIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jun 2009 (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.
This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).
Detailed description
This is a phase 2 study to evaluate the safety and effectiveness of using light-activated talaporfin sodium in patients with LUTS due to BPH who are candidates for interventional therapy.
The eligible patient will undergo placement of a proprietary drug activator into the prostatic urethra. Following the placement of the drug activator, patients will receive talaporfin sodium at 1 mg/kg intravenously by slow push over 3-5 minutes. Fifteen minutes after injection a light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes.
SAE reporting will occur from the day of treatment (Day 0) through end of study (month 12), inclusive. Any SAE that is still ongoing at the end of the study will be followed until assessed as chronic, stable or resolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LS11 (talaporfin sodium) | Experimental | Drug: talaporfin sodium, Device: Transurethral illumination with light emitting diodes, Procedure: Placement |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males, aged 50 years or older with prior diagnosis of BPH;
- Patients may be eligible whether or not they are on medication for LUTS due to BPH.
- Patients who are candidates for interventional therapy;
- Patients who understand and have the ability to sign written informed consent prior to any study procedures and/or discontinuation of exclusionary medications;
- Patients with an International Prostate Symptom Score of ≥ 15 points;
Key exclusion criteria (21 listed)
- Patients with any previous minimally invasive or surgical intervention for BPH.
- Patients who are currently enrolled in or who have enrolled in another clinical trial for any disease within the past 30 days.
- Patients with an active urinary tract infection.
- Patients with a urethral stricture.
- Patients with interstitial cystitis.
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 |
|---|---|---|
| talaporfin sodiumAlso: LS11LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes) | Drug | LS11 (talaporfin sodium) |
| Transurethral illumination with light emitting diodesA light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes | Device | LS11 (talaporfin sodium) |
| PlacementPlacement of device in prostate urethra | Procedure or surgery | LS11 (talaporfin sodium) |
Primary outcome
Safety of light-activated talaporfin sodium by recording of Adverse Events; Preliminary effectiveness of light-activated talaporfin sodium by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS).
Time frame: 12 months
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 16 Nov 2012.
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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.
Sy-Shi Wang, PhD study director
Light Sciences Oncology
8 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 talaporfin sodium, Transurethral illumination with light emitting diodes and Placement in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Light Sciences Oncology at 8 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 9 inclusion and 21 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 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in New Zealand, Australia. 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 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 of light-activated talaporfin sodium by recording of Adverse Events; Preliminary effectiveness of light-activated talaporfin sodium by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS). (time frame: 12 months). 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 16 Nov 2012.