Benign Prostatic HyperplasiaPhase 1NCT00709488
Phase 1 Study of the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
A Phase 1 study testing Talaporfin sodium, Placement of device in prostate urethra and Transurethral illumination with light emitting diodes (Litx™ BPH Device) in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Light Sciences Oncology at 6 sites in United States.
Trial summary
This is a phase 1 study to evaluate the safety and effectiveness of using the Litx™ BPH System in patients with LUTS due to benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Talaporfin sodium, Placement of device in prostate urethra and Transurethral illumination with light emitting diodes (Litx™ BPH Device)
- 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
- 12 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2008to Apr 2011
- Phase
- Phase 1
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, 50 years or older, who are on an alpha blocker and/or a 5-alpha reductase inhibitor or a combination, and are candidates for interventional therapy. Patients to continue on an alpha blocker and/or 5-alpha reductase inhibitor for at least one-month after the Litx™ treatment, then tapered off medication at physician's discretion.
- Patients who understand and have the ability to sign written informed consent prior to any study procedures and discontinuation of exclusionary medications.
- Patients with moderate to severe BPH bother score >3 requiring non-medication intervention.
- Patients with an IPSS1 Score of >15 points.
- Maximum urinary flow rate (Qmax) ≤15 mL/sec.
- Post void residual volume (PVR) ≤300 mL.
- Prostatic volume >50g by TRUS.
Who cannot join
- Patients with any previous minimally invasive or surgical intervention for BPH.
- Patients who have enrolled, or are currently 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 a predominant middle lobe obstruction.
- Patients who have evidence or history of prostate or bladder cancer.
Show all 19Show fewer
- Patients with a PSA of >10 ng/ml. If the PSA is 4-10 ng/ml, preliminary biopsy should be done within one-year prior to entry into the study to rule out prostate cancer.
- 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 or currently taking medications that prolong 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; SGOT and SGPT >3 x ULN; Creatinine >1.2 mg/dL
- Known sensitivity to porphyrin-type drugs or known history of porphyria.
- Known sensitivity to antibiotics (i.e., levofloxacin, gentamicin, etc.).
- Inability to avoid sunlight after procedure during the first 2 weeks after LS11 administration.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Alaska Clinical Research Center
Anchorage, Alaska, 99508
UCLA School of Medicine, GU Clinical Trials Office
Los Angeles, California, 90095
Integrity Medical Research
Mountlake Terrace, Washington, 98043
The Portland Clinic
Portland, Oregon, 97205
Urology San Antonio Research
San Antonio, Texas, 78229
Seattle Urological Associates
Seattle, Washington, 98104
About this study
Official title: A Phase 1 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 1 study to evaluate the safety and effectiveness of using the Litx™ BPH System in patients with LUTS due to benign prostatic hyperplasia (BPH).
Read the detailed description
The eligible patients will be enrolled into one of the three Litx™ treatment Cohorts (A, B or C)
All patients will undergo the procedure of Litx™ BPH Device placement into the prostate urethra.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort A will be administered an intravenous dose of LS11 (talaporfin sodium) at 1 mg/kg by slow push over 3 - 5 minutes. Fifteen minutes after injection, each patient will be administered a 50 J total light dose, delivered at 20 mW/cm over a 42 minute time period.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort B will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 70 J will be delivered to each patient over a 58 minute time period.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort C will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 100 J will be delivered to each patient over a 83 minute time period.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort D will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort C except that the active light emitting length is 20 mm instead of 10mm.
After 30 days, patients who have not experienced an improvement in symptoms, as determined by the investigator, may undergo an additional interventional therapy with continued follow-up per the protocol.
Four weeks following treatment of the last patient in the current cohort, the number of patients requiring surgical intervention for relief of primary symptoms will be assessed for futility of the protocol prior to commencing with treatment of the first patient in the next consecutive cohort.
Upon acceptable safety assessment four weeks after completing the last patient treatment in each cohort, the first patient in the next consecutive cohort may be treated.
- Being tested
- Talaporfin sodium, Placement of device in prostate urethra, Transurethral illumination with light emitting diodes (Litx™ BPH Device)
- Keywords
- Litx™ BPH System, LS11, 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, Mono-L-aspartyl Chlorin e6
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Placement of device in prostate urethraProcedure or surgery
Placement of device in prostate urethra
Transurethral illumination with light emitting diodes (Litx™ BPH Device)Device
Patients in Cohort A will receive 50 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort B will receive 70 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort C will receive 100 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort D will receive 100 J of light treatment (with the active light emitting length increased from 10mm to 20 mm) with 1 mg/kg LS11 administration.
| Study group | Role | What they receive |
|---|---|---|
| Litx™ BPH Therapy | Experimental | Not described Receives: Drug: Talaporfin sodium; Procedure: Placement of device in prostate urethra; Device: Transurethral illumination with light emitting diodes (Litx™ BPH Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Litx™ BPH System by Recording of Adverse Events; Preliminary effectiveness of Litx™ BPH System by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS).
Measured: 9 months
Secondary outcomes (1)
To assess the effect of the Litx™ treatment following tests by: Maximum urinary flow rate (Qmax); Post void residual volume (PVR); Transrectal ultrasound (TRUS) to measure prostate size and treatment effect.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2011
- Study completionApr 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709488
- Sponsor's protocol ID
- LSO-OL008
- Status last verified
- Nov 2012
- First submitted
- 30 Jun 2008
- 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 1 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
- NCT00709488
- Acronym / sponsor ID
- LSO-OL008
- Keywords
- Litx™ BPH System, LS11, Talaporfin sodium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Light Sciences OncologyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Jul 2008 (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 1 study to evaluate the safety and effectiveness of using the Litx™ BPH System in patients with LUTS due to benign prostatic hyperplasia (BPH).
Detailed description
The eligible patients will be enrolled into one of the three Litx™ treatment Cohorts (A, B or C)
All patients will undergo the procedure of Litx™ BPH Device placement into the prostate urethra.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort A will be administered an intravenous dose of LS11 (talaporfin sodium) at 1 mg/kg by slow push over 3 - 5 minutes. Fifteen minutes after injection, each patient will be administered a 50 J total light dose, delivered at 20 mW/cm over a 42 minute time period.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort B will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 70 J will be delivered to each patient over a 58 minute time period.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort C will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 100 J will be delivered to each patient over a 83 minute time period.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort D will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort C except that the active light emitting length is 20 mm instead of 10mm.
After 30 days, patients who have not experienced an improvement in symptoms, as determined by the investigator, may undergo an additional interventional therapy with continued follow-up per the protocol.
Four weeks following treatment of the last patient in the current cohort, the number of patients requiring surgical intervention for relief of primary symptoms will be assessed for futility of the protocol prior to commencing with treatment of the first patient in the next consecutive cohort.
Upon acceptable safety assessment four weeks after completing the last patient treatment in each cohort, the first patient in the next consecutive cohort may be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Litx™ BPH Therapy | Experimental | Drug: Talaporfin sodium, Procedure: Placement of device in prostate urethra, Device: Transurethral illumination with light emitting diodes (Litx™ BPH Device) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males, 50 years or older, who are on an alpha blocker and/or a 5-alpha reductase inhibitor or a combination, and are candidates for interventional therapy. Patients to continue on an alpha blocker and/or 5-alpha reductase inhibitor for at least one-month after the Litx™ treatment, then tapered off medication at physician's discretion.
- Patients who understand and have the ability to sign written informed consent prior to any study procedures and discontinuation of exclusionary medications.
- Patients with moderate to severe BPH bother score >3 requiring non-medication intervention.
- Patients with an IPSS1 Score of >15 points.
- Maximum urinary flow rate (Qmax) ≤15 mL/sec.
Key exclusion criteria (19 listed)
- Patients with any previous minimally invasive or surgical intervention for BPH.
- Patients who have enrolled, or are currently 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 a predominant middle lobe obstruction.
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: LS11, Mono-L-aspartyl Chlorin e6LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes). | Drug | Litx™ BPH Therapy |
| Placement of device in prostate urethraPlacement of device in prostate urethra | Procedure or surgery | Litx™ BPH Therapy |
| Transurethral illumination with light emitting diodes (Litx™ BPH Device)Patients in Cohort A will receive 50 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort B will receive 70 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort C will receive 100 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort D will receive 100 J of light treatment (with the active light emitting length increased from 10mm to 20 mm) with 1 mg/kg LS11 administration. | Device | Litx™ BPH Therapy |
Primary outcome
Safety of Litx™ BPH System by Recording of Adverse Events; Preliminary effectiveness of Litx™ BPH System by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS).
Time frame: 9 months
1 secondary outcome
To assess the effect of the Litx™ treatment following tests by: Maximum urinary flow rate (Qmax); Post void residual volume (PVR); Transrectal ultrasound (TRUS) to measure prostate size and treatment effect.
Time frame: 9 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, Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talaporfin sodium, Placement of device in prostate urethra and Transurethral illumination with light emitting diodes (Litx™ BPH Device) in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Light Sciences Oncology at 6 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 7 inclusion and 19 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 6 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. 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 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.
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 Litx™ BPH System by Recording of Adverse Events; Preliminary effectiveness of Litx™ BPH System by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS). (time frame: 9 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; AzTrials last refreshed its copy on 6 Nov 2026.