Status:
COMPLETED
Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Light Sciences Oncology
Conditions:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
50+ years
Phase:
PHASE2
Brief 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).
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 eligibl...
Eligibility Criteria
Inclusion
- 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);
- Maximum urinary flow rate (Qmax) ≤ 15 mL/sec;
- Post void residual volume (PVR) ≤ 300 mL;
- Length of prostatic urethra ≥ 4.0 cm.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00918034
Start Date
May 1 2009
End Date
February 1 2011
Last Update
November 16 2012
Active Locations (8)
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1
Royal Brisbane and Women's Hospital Center of Clinical Research
Herston, Australia
2
Bayside Urology
Mentone, Australia
3
Princess Alexandra Hospital
Wolloongabba, Australia, QLD 4102
4
Canterbury Urology Research Trust Hiatt Chambers St. George's Medical Centre
Christchurch, New Zealand