Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Light Sciences Oncology
ClinicalTrials.gov Identifier:
NCT00918034
First received: June 9, 2009
Last updated: November 14, 2012
Last verified: November 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Light Sciences Oncology:

Primary Outcome Measures:
  • Safety of light-activated talaporfin sodium by recording of Adverse Events; Preliminary effectiveness of light-activated talaporfin sodium by evaluating the International Prostate Symptom Score (IPSS) along with Bother Score (BS). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: May 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LS11 (talaporfin sodium) Drug: talaporfin sodium
LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)
Other Name: LS11
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

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. Males, aged 50 years or older with prior diagnosis of BPH;
  2. Patients may be eligible whether or not they are on medication for LUTS due to BPH.
  3. Patients who are candidates for interventional therapy;
  4. Patients who understand and have the ability to sign written informed consent prior to any study procedures and/or discontinuation of exclusionary medications;
  5. Patients with an International Prostate Symptom Score of ≥ 15 points;
  6. Patients with moderate to severe BPH (Bother Score ≥ 3);
  7. Maximum urinary flow rate (Qmax) ≤ 15 mL/sec;
  8. Post void residual volume (PVR) ≤ 300 mL;
  9. Length of prostatic urethra ≥ 4.0 cm.

Exclusion Criteria:

  1. Patients with any previous minimally invasive or surgical intervention for BPH.
  2. Patients who are currently enrolled in or who have enrolled in another clinical trial for any disease within the past 30 days.
  3. Patients with an active urinary tract infection.
  4. Patients with a urethral stricture.
  5. Patients with interstitial cystitis.
  6. Patients with a predominant middle lobe obstruction.
  7. Patients who have evidence or history of prostate or bladder cancer or carcinoma in situ of the bladder.
  8. Patients with an abnormal digital rectal exam suggestive of carcinoma of the prostate.
  9. Patients with an abnormal digital rectal exam suggestive of an indurated nodule.
  10. Patients with a PSA of > 10 ng/ml. If the PSA is 4-10 ng/ml, local standard of care should be pursued to ensure the possibility of prostate cancer is followed up and ruled out prior to, entry into the study.
  11. Patients who had a biopsy of the prostate within the past 6 weeks.
  12. Patients with bleeding diathesis.
  13. Patients with clinically significant renal or hepatic impairment.
  14. Patients with neurological conditions felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder.
  15. Patients who daily use a pad or device for incontinence.
  16. 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.
  17. Patient has an interest in future fertility.
  18. Patients with prolonged QT interval at baseline and/or who are currently taking medication that prolongs QT interval ("prolonged QT interval" defined as > 450 ms).
  19. 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; AST and ALT >3 x ULN; Creatinine >1.5 x ULN
  20. Known sensitivity to porphyrin-type drugs or known history of porphyria.
  21. Inability to avoid bright indoor lighting and sunlight during the first 72 hours after LS11 administration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918034

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
Sponsors and Collaborators
Light Sciences Oncology
Investigators
Study Director: Sy-Shi Wang, PhD Light Sciences Oncology
  More Information

No publications provided

Responsible Party: Light Sciences Oncology
ClinicalTrials.gov Identifier: NCT00918034     History of Changes
Other Study ID Numbers: LSO-OL012
Study First Received: June 9, 2009
Last Updated: November 14, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by Light Sciences Oncology:
BPH
LUTS
talaporfin sodium

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Urological Manifestations
Signs and Symptoms
Talaporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014