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

NCT00709488 | Completed Phase 1

• 1 other identifier: LSO-OL008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Litx™ BPH System; LS11; Talaporfin sodium

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  9 months

Study Arms (1)

Litx™ BPH Therapy

EXPERIMENTAL

Drug: Talaporfin sodium; Procedure: Placement of device in prostate urethra; Device: Transurethral illumination with light emitting diodes (Litx™ BPH Device)

Interventions

Talaporfin sodium DRUG

LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).

Also known as: LS11, Mono-L-aspartyl Chlorin e6

Litx™ BPH Therapy

Placement of device in prostate urethra PROCEDURE

Placement of device in prostate urethra

Litx™ BPH Therapy

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.

Litx™ BPH Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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).

Sponsors & Collaborators

• Light Sciences Oncology: lead

Study Sites (6)

Alaska Clinical Research Center

Anchorage, Alaska, 99508, United States

Location

UCLA School of Medicine, GU Clinical Trials Office

Los Angeles, California, 90095, United States

Location

The Portland Clinic

Portland, Oregon, 97205, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Integrity Medical Research

Mountlake Terrace, Washington, 98043, United States

Location

Seattle Urological Associates

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Talaporfin; Embryo Implantation

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Embryonic Development; Embryonic and Fetal Development; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Sy-Shi Wang, PhD

  Light Sciences Oncology, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 3, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

US (6)