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

Sponsored by:	Light Sciences Oncology
Information provided by:	Light Sciences Oncology
ClinicalTrials.gov Identifier:	NCT00709488

Purpose

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).

Condition	Intervention	Phase
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms	Drug: Talaporfin sodium Procedure: Placement of device in prostate urethra Device: Transurethral illumination with light emitting diodes (Litx™ BPH Device)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Monoaspartyl chlorin e6 Talaporfin sodium

U.S. FDA Resources

Further study details as provided by Light Sciences Oncology:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	June 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Litx™ BPH Therapy: Experimental	Drug: Talaporfin sodium LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes). Procedure: Placement of device in prostate urethra Placement of device in prostate urethra Device: Transurethral illumination with light emitting diodes (Litx™ BPH 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.

Arms

Assigned Interventions

Litx™ BPH Therapy: Experimental

Drug: Talaporfin sodium

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

Procedure: Placement of device in prostate urethra

Placement of device in prostate urethra

Device: Transurethral illumination with light emitting diodes (Litx™ BPH 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.

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709488

Locations

United States, California
UCLA School of Medicine, GU Clinical Trials Office	Recruiting
Los Angeles, California, United States, 90095
Contact: Malu Macairan 310-794-3566
Principal Investigator: Leonard S Marks, MD
United States, Oregon
The Portland Clinic	Recruiting
Portland, Oregon, United States, 97205
Contact: Susan Stindt 503-221-0161 ext 2109
Principal Investigator: Ehud Zusman, MD
United States, Washington
Integrity Medical Research	Recruiting
Mountlake Terrace, Washington, United States, 98043
Contact: Somar Macek 425-275-0680
Principal Investigator: Karny Jacoby, MD
Seattle Urological Associates	Recruiting
Seattle, Washington, United States, 98104
Contact: Jenni Gallagher 206-838-1638
Contact: Angie Sievers
Principal Investigator: Erik Torgerson, MD

Sponsors and Collaborators

Light Sciences Oncology

Investigators

Study Director:

Sy-Shi Wang, PhD

Light Sciences Oncology, Inc.

More Information

No publications provided

Responsible Party:	Light Sciences Oncology, Inc. ( Sy-Shi Wang/Study Director )
Study ID Numbers:	LSO-OL008
Study First Received:	June 30, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00709488 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Light Sciences Oncology:

Litx™ BPH System
LS11
Talaporfin sodium

Study placed in the following topic categories:

Photosensitizing Agents
Hyperplasia
Radiation-Sensitizing Agents
Talaporfin

Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

Additional relevant MeSH terms:

Prostatic Diseases
Talaporfin
Antineoplastic Agents
Physiological Effects of Drugs
Genital Diseases, Male
Pharmacologic Actions
Hyperplasia

Photosensitizing Agents
Pathologic Processes
Prostatic Hyperplasia
Radiation-Sensitizing Agents
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on July 02, 2009