NCT00709488

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Light Sciences Oncology · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-07-03
• Last updated: 2012-11-16

Locations

6 sites across 1 country: United States