NCT00077012

Brief Summary

The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074. Secondary objectives are:

  1. 1.To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR).
  2. 2.To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection.
  3. 3.To select up to two transurethral PDT drug-light regimens for further clinical development.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2003

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

February 9, 2004

Last Update Submit

May 22, 2012

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH

Interventions

QLT0074DRUG
Photodynamic therapyDRUG

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Twenty-seven men with symptomatic BPH despite adequate drug therapy and who are candidates for surgical or minimally invasive treatment will be enrolled in the study. * Subjects must have an AUA SI \>13, Qmax between 5 and 15 mL/sec, and a urethral treatment length between 30 and 65 mm (defined as the length of the urethra between the bladder neck and the edge of the verumontanum distal to the bladder).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Raymond Fay, MD, Inc

San Francisco, California, 94108, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Advanced Research Institute Inc

New Port Richey, Florida, 34652, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

North Texas Veteran Affairs Health Care System

Dallas, Texas, 75216, United States

Location

The Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 3J5, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

QLT0074Photochemotherapy

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2004

First Posted

February 11, 2004

Study Start

March 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

CA(2)US(5)