NCT00918034

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

1.8 years

First QC Date

June 9, 2009

Last Update Submit

November 14, 2012

Conditions

Benign Prostatic HyperplasiaLower Urinary Tract Symptoms

Keywords

BPHLUTStalaporfin sodium

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

LS11 (talaporfin sodium)

EXPERIMENTAL
Drug: talaporfin sodiumDevice: Transurethral illumination with light emitting diodesProcedure: Placement

Interventions

talaporfin sodiumDRUG

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

Also known as: LS11
LS11 (talaporfin sodium)
Transurethral illumination with light emitting diodesDEVICE

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

LS11 (talaporfin sodium)
PlacementPROCEDURE

Placement of device in prostate urethra

LS11 (talaporfin sodium)

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males, aged 50 years or older with prior diagnosis of BPH;
  • Patients may be eligible whether or not they are on medication for LUTS due to BPH.
  • Patients who are candidates for interventional therapy;
  • Patients with an International Prostate Symptom Score of ≥ 15 points;
  • Patients with moderate to severe BPH (Bother Score ≥ 3);
  • Maximum urinary flow rate (Qmax) ≤ 15 mL/sec;
  • Post void residual volume (PVR) ≤ 300 mL;
  • Length of prostatic urethra ≥ 4.0 cm.

You may not qualify if:

  • Patients with any previous minimally invasive or surgical intervention for BPH.
  • Patients who are currently enrolled in or who have enrolled in another clinical trial for any disease within the past 30 days.
  • Patients with an active urinary tract infection.
  • Patients with a urethral stricture.
  • Patients with interstitial cystitis.
  • Patients with a predominant middle lobe obstruction.
  • Patients who have evidence or history of prostate or bladder cancer or carcinoma in situ of the bladder.
  • Patients with an abnormal digital rectal exam suggestive of carcinoma of the prostate.
  • Patients with an abnormal digital rectal exam suggestive of an indurated nodule.
  • 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.
  • Patients who had a biopsy of the prostate within the past 6 weeks.
  • Patients with bleeding diathesis.
  • Patients with clinically significant renal or hepatic impairment.
  • Patients with neurological conditions felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder.
  • Patients who daily use a pad or device for incontinence.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Royal Brisbane and Women's Hospital Center of Clinical Research

Herston, Australia

Location

Bayside Urology

Mentone, Australia

Location

Princess Alexandra Hospital

Wolloongabba, QLD 4102, Australia

Location

Canterbury Urology Research Trust Hiatt Chambers St. George's Medical Centre

Christchurch, New Zealand

Location

Roundhay Medical Centre

Nelson, New Zealand

Location

Tauranga Urology Research, Ltd.

Tauranga, New Zealand

Location

Wellington Urology Research Group Wakefield Urology

Wellington, New Zealand

Location

Kensington Hospital Cardinal Points Specialist Centre

Whangarei, New Zealand

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Interventions

TalaporfinDrug Implants

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Sy-Shi Wang, PhD

    Light Sciences Oncology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 16, 2012

Record last verified: 2012-11

Locations

AU(3)NZ(5)