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

NCT01166230 | Completed Results

• 1 other identifier: PC B305/E10
• Study Type: observational
• Target: 551
• Locations: 5 countries
• Sites: 24

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

  up to 4.5 years

Secondary Outcomes (1)

• Rate of Progression

  4.5 years

Other Outcomes (2)

• Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB

  up to 5.5 years retrospectively

• Median Time to Recurrence

  up to 4.5 years

Study Arms (2)

Patients with Ta/T1, randomized to white light cystoscopy

Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.

Patients with Ta/T1 randomized to Hexvix cystoscopy

Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-invasive papillary bladder cancer, enrolled in the previously completed pivotal phase III study PC B305/04, who were followed for recurrence will be included in this study.

You may qualify if:

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

You may not qualify if:

• Patient died during clinical study PC B305/04

Sponsors & Collaborators

• Photocure: lead

Study Sites (24)

Stanford Cancer Center, Department of Urology

Stanford, California, 94305-5820, United States

Location

V.A. Medical Center

Gainesville, Florida, 32608, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

South Florida Clinical Research Center, Inc.

Pembroke Pines, Florida, 33028, United States

Location

The Emory Clinic, Dept of Urology

Atlanta, Georgia, 30322, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai Medical Center, Department of Urology

New York, New York, 10029-6574, United States

Location

URMC

Rochester, New York, 14642, United States

Location

Thomas Jefferson Medical College, Department of Neurology

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center, Department of Urologic Surgery

Nashville, Tennessee, 37232-2765, United States

Location

Baylor College of Medicine, Scott Department of Urology

Houston, Texas, 77030-2726, United States

Location

The University of Texas MD Anderson cancer center

Houston, Texas, 77030-4009, United States

Location

AKH, Klinik für Urologie der Universität Wien

Vienna, 1090, Austria

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

CHUQ Hotel-Dieu de Quebec

Québec, G1R 2J6, Canada

Location

University Clinic of Giessen, Department of Urology

Giessen, 35392, Germany

Location

Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik

München, 81377, Germany

Location

Urologische Klinik München-Planegg

Planegg, 82152, Germany

Location

Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie

Regensburg, 93053, Germany

Location

Universitätsklinik Tuebingen, Universitätsklinik für Urologie

Tübingen, 72076, Germany

Location

Department of Urology, Academic Medical Center, University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Department of Urology, UMC St. Radboud

Nijmegen, 6500 HB, Netherlands

Location

Related Links

• Bladder Cancer Advocacy Network (BCAN)

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: H. Barton Grossman, MD
• Organization: The University of Texas

hbgrossman@mdanderson.org

713-563-7456

Study Officials

• Herbert Barton Grossman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 20, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 9, 2019
• Results First Posted: November 14, 2013

Record last verified: 2019-03

Locations

DE (5); AU (1); NL (2); CA (2); US (14)