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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Light Sciences Oncology
• Treatments: Talaporfin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.