Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

Bladder Cancer Clinical Trial

Official title:

An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB305/04, to Assess Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Transurethral Resection of the Bladder (TURB) or White Light Cystoscopy/TURB

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166230
• Other study ID #: PC B305/E10
• Status: Completed
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2019
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

Description:

A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone.

The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

No safety data was collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of study PC B305/04 with Ta or T1, that were followed for recurrence are eligible to be included in this study.

Exclusion Criteria:

• Patient died during clinical study PC B305/04

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Austria	AKH, Klinik für Urologie der Universität Wien	Wien
Canada	Kingston General Hospital	Kingston	Ontario
Canada	CHUQ Hotel-Dieu de Quebec	Quebec
Germany	University Clinic of Giessen, Department of Urology	Giessen
Germany	Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik	München
Germany	Urologische Klinik München-Planegg	Planegg
Germany	Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie	Regensburg
Germany	Universitätsklinik Tuebingen, Universitätsklinik für Urologie	Tuebingen
Netherlands	Department of Urology, Academic Medical Center, University of Amsterdam	Amsterdam
Netherlands	Department of Urology, UMC St. Radboud	Nijmegen
United States	The Emory Clinic, Dept of Urology	Atlanta	Georgia
United States	Boston University School of Medicine	Boston	Massachusetts
United States	V.A. Medical Center	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Baylor College of Medicine, Scott Department of Urology	Houston	Texas
United States	The University of Texas MD Anderson cancer center	Houston	Texas
United States	University of Miami School of Medicine	Miami	Florida
United States	Vanderbilt University Medical Center, Department of Urologic Surgery	Nashville	Tennessee
United States	Mount Sinai Medical Center, Department of Urology	New York	New York
United States	South Florida Clinical Research Center, Inc.	Pembroke Pines	Florida
United States	Thomas Jefferson Medical College, Department of Neurology	Philadelphia	Pennsylvania
United States	URMC	Rochester	New York
United States	Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester	Rochester	Minnesota
United States	Stanford Cancer Center, Department of Urology	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB	To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.	up to 5.5 years retrospectively
Other	Median Time to Recurrence		up to 4.5 years
Primary	Recurrence Free Survival		up to 4.5 years
Secondary	Rate of Progression	Only patients with Ta/T1 were included in the follow-up study. "Progression" is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence.	4.5 years

External Links

•   Bladder Cancer Advocacy Network (BCAN)