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| Sponsor: | Light Sciences Oncology |
|---|---|
| Information provided by: | Light Sciences Oncology |
| ClinicalTrials.gov Identifier: | NCT00918034 |
Purpose
This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms |
Drug: talaporfin sodium Device: Transurethral illumination with light emitting diodes Procedure: Placement |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| LS11 (talaporfin sodium): Experimental |
Drug: talaporfin sodium
LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)
Device: Transurethral illumination with light emitting diodes
A light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes
Procedure: Placement
Placement of device in prostate urethra
|
This is a phase 2 study to evaluate the safety and effectiveness of using light-activated talaporfin sodium in patients with LUTS due to BPH who are candidates for interventional therapy.
The eligible patient will undergo placement of a proprietary drug activator into the prostatic urethra. Following the placement of the drug activator, patients will receive talaporfin sodium at 1 mg/kg intravenously by slow push over 3-5 minutes. Fifteen minutes after injection a light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes.
SAE reporting will occur from the day of treatment (Day 0) through end of study (month 12), inclusive. Any SAE that is still ongoing at the end of the study will be followed until assessed as chronic, stable or resolved.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia | |
| Royal Brisbane and Women's Hospital Center of Clinical Research | |
| Herston, Australia | |
| Bayside Urology | |
| Mentone, Australia | |
| Princess Alexandra Hospital | |
| Wolloongabba, Australia, QLD 4102 | |
| New Zealand | |
| Canterbury Urology Research Trust Hiatt Chambers St. George's Medical Centre | |
| Christchurch, New Zealand | |
| Roundhay Medical Centre | |
| Nelson, New Zealand | |
| Tauranga Urology Research, Ltd. | |
| Tauranga, New Zealand | |
| Wellington Urology Research Group Wakefield Urology | |
| Wellington, New Zealand | |
| Kensington Hospital Cardinal Points Specialist Centre | |
| Whangarei, New Zealand | |
| Study Director: | Sy-Shi Wang, PhD | Light Sciences Oncology |
More Information
| Responsible Party: | Light Sciences Oncology, Inc. ( Sy-Shi Wang, PhD/Study Director ) |
| ClinicalTrials.gov Identifier: | NCT00918034 History of Changes |
| Other Study ID Numbers: | LSO-OL012 |
| Study First Received: | June 9, 2009 |
| Last Updated: | August 4, 2010 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe |
|
BPH LUTS talaporfin sodium |
|
Hyperplasia Prostatic Hyperplasia Pathologic Processes Prostatic Diseases Genital Diseases, Male Talaporfin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |