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

November 14, 2012 updated by: Light Sciences Oncology

A Phase 1 Study to Evaluate the Safety and Effectiveness of Using the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Who Are Candidates for Interventional Therapy

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).

Study Overview

Detailed Description

The eligible patients will be enrolled into one of the three Litx™ treatment Cohorts (A, B or C)

All patients will undergo the procedure of Litx™ BPH Device placement into the prostate urethra.

Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort A will be administered an intravenous dose of LS11 (talaporfin sodium) at 1 mg/kg by slow push over 3 - 5 minutes. Fifteen minutes after injection, each patient will be administered a 50 J total light dose, delivered at 20 mW/cm over a 42 minute time period.

Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort B will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 70 J will be delivered to each patient over a 58 minute time period.

Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort C will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 100 J will be delivered to each patient over a 83 minute time period.

Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort D will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort C except that the active light emitting length is 20 mm instead of 10mm.

After 30 days, patients who have not experienced an improvement in symptoms, as determined by the investigator, may undergo an additional interventional therapy with continued follow-up per the protocol.

Four weeks following treatment of the last patient in the current cohort, the number of patients requiring surgical intervention for relief of primary symptoms will be assessed for futility of the protocol prior to commencing with treatment of the first patient in the next consecutive cohort.

Upon acceptable safety assessment four weeks after completing the last patient treatment in each cohort, the first patient in the next consecutive cohort may be treated.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Clinical Research Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine, GU Clinical Trials Office
    • Oregon
      • Portland, Oregon, United States, 97205
        • The Portland Clinic
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Integrity Medical Research
      • Seattle, Washington, United States, 98104
        • Seattle Urological Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Litx™ BPH Therapy
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Other Names:
  • LS11
  • Mono-L-aspartyl Chlorin e6
Placement of device in prostate urethra
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Sy-Shi Wang, PhD, Light Sciences Oncology, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (ESTIMATE)

July 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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