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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918034
• Other study ID #: LSO-OL012
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2009
• Last updated: November 14, 2012
• Start date: May 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2012
• Source: Light Sciences Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, 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 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

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital Center of Clinical Research	Herston
Australia	Bayside Urology	Mentone
Australia	Princess Alexandra Hospital	Wolloongabba
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

Sponsors (1)

Lead Sponsor	Collaborator
Light Sciences Oncology

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		12 months	Yes