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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00918034




Registration number
NCT00918034
Ethics application status
Date submitted
9/06/2009
Date registered
11/06/2009
Date last updated
16/11/2012

Titles & IDs
Public title
Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Scientific 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
Secondary ID [1] 0 0
LSO-OL012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Lower Urinary Tract Symptoms 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - talaporfin sodium
Treatment: Devices - Transurethral illumination with light emitting diodes
Treatment: Surgery - Placement

Experimental: LS11 (talaporfin sodium) -


Treatment: Drugs: talaporfin sodium
LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)

Treatment: Devices: 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

Treatment: Surgery: Placement
Placement of device in prostate urethra
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
12 months

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital Center of Clinical Research - Herston
Recruitment hospital [2] 0 0
Bayside Urology - Mentone
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Wolloongabba
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Mentone
Recruitment postcode(s) [3] 0 0
QLD 4102 - Wolloongabba
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Nelson
Country [3] 0 0
New Zealand
State/province [3] 0 0
Tauranga
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington
Country [5] 0 0
New Zealand
State/province [5] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Light Sciences Oncology
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00918034
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sy-Shi Wang, PhD
Address 0 0
Light Sciences Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00918034