Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
NCT ID: NCT00918034
Last Updated: 2012-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2009-05-31
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LS11 (talaporfin sodium)
talaporfin sodium
LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)
Transurethral illumination with light emitting diodes
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
Placement
Placement of device in prostate urethra
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
talaporfin sodium
LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)
Transurethral illumination with light emitting diodes
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
Placement
Placement of device in prostate urethra
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients may be eligible whether or not they are on medication for LUTS due to BPH.
3. Patients who are candidates for interventional therapy;
4. Patients who understand and have the ability to sign written informed consent prior to any study procedures and/or discontinuation of exclusionary medications;
5. Patients with an International Prostate Symptom Score of ≥ 15 points;
6. Patients with moderate to severe BPH (Bother Score ≥ 3);
7. Maximum urinary flow rate (Qmax) ≤ 15 mL/sec;
8. Post void residual volume (PVR) ≤ 300 mL;
9. Length of prostatic urethra ≥ 4.0 cm.
Exclusion Criteria
2. Patients who are currently enrolled in or who have enrolled in another clinical trial for any disease within the past 30 days.
3. Patients with an active urinary tract infection.
4. Patients with a urethral stricture.
5. Patients with interstitial cystitis.
6. Patients with a predominant middle lobe obstruction.
7. Patients who have evidence or history of prostate or bladder cancer or carcinoma in situ of the bladder.
8. Patients with an abnormal digital rectal exam suggestive of carcinoma of the prostate.
9. Patients with an abnormal digital rectal exam suggestive of an indurated nodule.
10. 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.
11. Patients who had a biopsy of the prostate within the past 6 weeks.
12. Patients with bleeding diathesis.
13. Patients with clinically significant renal or hepatic impairment.
14. Patients with neurological conditions felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder.
15. Patients who daily use a pad or device for incontinence.
16. 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.
17. Patient has an interest in future fertility.
18. 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).
19. 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
20. Known sensitivity to porphyrin-type drugs or known history of porphyria.
21. Inability to avoid bright indoor lighting and sunlight during the first 72 hours after LS11 administration.
50 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Light Sciences Oncology
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sy-Shi Wang, PhD
Role: STUDY_DIRECTOR
Light Sciences Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Brisbane and Women's Hospital Center of Clinical Research
Herston, , Australia
Bayside Urology
Mentone, , Australia
Princess Alexandra Hospital
Wolloongabba, , Australia
Canterbury Urology Research Trust Hiatt Chambers St. George's Medical Centre
Christchurch, , New Zealand
Roundhay Medical Centre
Nelson, , New Zealand
Tauranga Urology Research, Ltd.
Tauranga, , New Zealand
Wellington Urology Research Group Wakefield Urology
Wellington, , New Zealand
Kensington Hospital Cardinal Points Specialist Centre
Whangarei, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LSO-OL012
Identifier Type: -
Identifier Source: org_study_id