Phase 1 Study of the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Completed · Phase 1

Conditions studied: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

In brief

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).

Key facts

Study ID

NCT00709488

Run by

Light Sciences Oncology

People needed

12

Starts

2008-06-01

Expected to finish

2011-04-01

Last updated by the study team

2012-11-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Alaska Clinical Research Center — Anchorage, Alaska, United States
• UCLA School of Medicine, GU Clinical Trials Office — Los Angeles, California, United States
• The Portland Clinic — Portland, Oregon, United States
• Urology San Antonio Research — San Antonio, Texas, United States
• Integrity Medical Research — Mountlake Terrace, Washington, United States
• Seattle Urological Associates — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.