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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709488
• Other study ID #: LSO-OL008
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2008
• Last updated: November 14, 2012
• Start date: June 2008
• Est. completion date: April 2011

Study information

• Verified date: November 2012
• Source: Light Sciences Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

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; 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.

Locations

Country	Name	City	State
United States	Alaska Clinical Research Center	Anchorage	Alaska
United States	UCLA School of Medicine, GU Clinical Trials Office	Los Angeles	California
United States	Integrity Medical Research	Mountlake Terrace	Washington
United States	The Portland Clinic	Portland	Oregon
United States	Urology San Antonio Research	San Antonio	Texas
United States	Seattle Urological Associates	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Light Sciences Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No