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

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT01166230
• Lead Sponsor: Photocure

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-08-05
• Results First Submitted QC: 2013-10-22
• Results First Posted: 2013-11-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 551

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival	up to 4.5 years

Secondary Outcome Measures

Name	Time	Method
Rate of Progression	4.5 years	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.

Trial Locations

Locations (24)

Stanford Cancer Center, Department of Urology; 🇺🇸 Stanford, California, United States

V.A. Medical Center; 🇺🇸 Gainesville, Florida, United States

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

South Florida Clinical Research Center, Inc.; 🇺🇸 Pembroke Pines, Florida, United States

The Emory Clinic, Dept of Urology; 🇺🇸 Atlanta, Georgia, United States

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Mount Sinai Medical Center, Department of Urology; 🇺🇸 New York, New York, United States

URMC; 🇺🇸 Rochester, New York, United States

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