Clinical trial NCT00233402: Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
Official title: A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Hexvix
Fluorescence
Cystoscopy
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.

Detailed description: In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors (Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily overlooked. These lesions are predictive of recurrence and progression of disease, and the identification of these lesions is a crucial factor for the prognosis of the patient. The present situation with 50-75% recurrence rate show the inadequacy of white light cystoscopy for detection and resection of the lesions.

A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB, a more optimal pharmacological treatment when needed, may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient.

The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.

Eligibility criteria: Inclusion Criteria:

The patients should be indicated for a cystoscopic examination for suspected or verified papillary bladder cancer and fulfill one or more of the following criteria:

* Patients with more than one initial bladder tumor confirmed on an outpatient cystoscopy.
* Patients having recurrence within 12 months confirmed on an outpatient cystoscopy
* Patients with more than one papillary lesion at recurrence independently of the time of the recurrence confirmed on an outpatient cystoscopy

Exclusion Criteria:

* Patients with known tumors in the prostatic urethra or distal urethra
* Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
* Patient with porphyria.
* Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
* Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
* Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
* Patients who have received BCG or chemotherapy within three months prior to the initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.
* Conditions associated with a risk of poor protocol compliance.

Primary outcomes:
measure: Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light
timeFrame: Day 0
measure: Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.
timeFrame: 9 months
Secondary outcomes:
measure: Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.
timeFrame: Day 0
measure: Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.
timeFrame: Day 0
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Center, Department of Urology
state: California
city: Gainesville
country: United States
facility: V.A. Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Pembroke Pines
country: United States
facility: South Florida Clinical Research Center, Inc.
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic, Dept of Urology
state: Georgia
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital- Ann Arbor
state: Michigan
city: Rochester
country: United States
facility: Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center, Department of Urology
state: New York
city: Rochester
country: United States
facility: URMC
state: New York
city: Beachwood
country: United States
facility: Urological Institute at Beachwood Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Medical College, Department of Neurology
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Department of Urologic Surgery
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine, Scott Department of Urology
state: Texas
city: Wien
country: Austria
facility: AKH, Klinik für Urologie der Universität Wien
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Quebec
country: Canada
facility: CHUQ Hotel-Dieu de Quebec
city: Giessen
country: Germany
facility: University Clinic of Giessen, Department of Urology
city: München
country: Germany
facility: Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
city: Planegg
country: Germany
facility: Urologische Klinik München-Planegg
city: Regensburg
country: Germany
facility: Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
city: Tuebingen
country: Germany
facility: Universitätsklinik Tuebingen, Universitätsklinik für Urologie
city: Amsterdam
country: Netherlands
facility: Department of Urology, Academic Medical Center, University of Amsterdam
city: Nijmegen
country: Netherlands
facility: Department of Urology, UMC St. Radboud
Study officials:
affiliation: The University of Texas, MD Anderson Cancer Center, Department of Urology
name: H Barton Grossman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stenzl A, Burger M, Fradet Y, Mynderse LA, Soloway MS, Witjes JA, Kriegmair M, Karl A, Shen Y, Grossman HB. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol. 2010 Nov;184(5):1907-13. doi: 10.1016/j.juro.2010.06.148. Epub 2010 Sep 17.