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

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Talaporfin sodium

Placement of device in prostate urethra

Transurethral illumination with light emitting diodes (Litx™ BPH Device)

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Litx™ BPH System, LS11, Talaporfin sodium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Alaska Clinical Research Center
UCLA School of Medicine, GU Clinical Trials Office
The Portland Clinic
Urology San Antonio Research
Integrity Medical Research
Seattle Urological Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Litx™ BPH Therapy

Arm Description

Outcomes

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).

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.

Full Information

NCT ID

NCT00709488

First Posted

June 30, 2008

Last Updated

November 14, 2012

Sponsor

Light Sciences Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00709488

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Light Sciences Oncology

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Keywords

Litx™ BPH System, LS11, Talaporfin sodium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Litx™ BPH Therapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Talaporfin sodium

Other Intervention Name(s)

LS11, Mono-L-aspartyl Chlorin e6

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Placement of device in prostate urethra

Intervention Description

Placement of device in prostate urethra

Intervention Type

Device

Intervention Name(s)

Transurethral illumination with light emitting diodes (Litx™ BPH Device)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Time Frame

9 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sy-Shi Wang, PhD

Organizational Affiliation

Light Sciences Oncology, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Alaska Clinical Research Center

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Facility Name

UCLA School of Medicine, GU Clinical Trials Office

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

The Portland Clinic

City

Portland

State/Province

Oregon

ZIP/Postal Code

97205

Country

United States

Facility Name

Urology San Antonio Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Integrity Medical Research

City

Mountlake Terrace

State/Province

Washington

ZIP/Postal Code

98043

Country

United States

Facility Name

Seattle Urological Associates

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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