Bladder CancerPhase 3NCT00233402
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
A Phase 3 study testing Hexvix and Standard white light cystoscopy in people with Bladder Cancer, run by Photocure at 25 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Hexvix and Standard white light cystoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 789 participants
- Where
- 25 sitesin 5 countries
- Study dates
- Jan 2005to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States15 sites
St. Joseph Mercy Hospital- Ann Arbor
Ann Arbor, Michigan, 48106
The Emory Clinic, Dept of Urology
Atlanta, Georgia, 30322
Urological Institute at Beachwood Cleveland Clinic
Beachwood, Ohio, 44120
Boston University School of Medicine
Boston, Massachusetts, 02118
V.A. Medical Center
Gainesville, Florida, 32608
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, 77030-2726
University of Miami School of Medicine
Miami, Florida, 33136
Vanderbilt University Medical Center, Department of Urologic Surgery
Nashville, Tennessee, 37232-2765
Mount Sinai Medical Center, Department of Urology
New York, New York, 10029-6574
South Florida Clinical Research Center, Inc.
Pembroke Pines, Florida, 33028
Thomas Jefferson Medical College, Department of Neurology
Philadelphia, Pennsylvania, 19107
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
Rochester, Minnesota, 55905
URMC
Rochester, New York, 14642
Stanford Cancer Center, Department of Urology
Stanford, California, 94305-5820
Germany5 sites
University Clinic of Giessen, Department of Urology
Giessen, 35392
Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
München, 81377
Urologische Klinik München-Planegg
Planegg, 82152
Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
Regensburg, 93053
Universitätsklinik Tuebingen, Universitätsklinik für Urologie
Tübingen, 72076
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
CHUQ Hotel-Dieu de Quebec
Québec, G1R 2J6
Netherlands2 sites
Department of Urology, Academic Medical Center, University of Amsterdam
Amsterdam, 1105 AZ
Department of Urology, UMC St. Radboud
Nijmegen, 6500 HB
About this study
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
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Hexvix, Standard white light cystoscopy
- Keywords
- Bladder Cancer, Hexvix, Fluorescence, Cystoscopy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HexvixDrug
Single Instillation, Transurethral Resection of the Bladder
Standard white light cystoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard White Light Cystoscopy | Active comparator | Not described Receives: Procedure: Standard white light cystoscopy |
| Standard White Light and Hexvix Fluorescence Cystoscopy | Experimental | Not described Receives: Drug: Hexvix; Procedure: Standard white light cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light
Measured: Day 0
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.
Measured: 9 months
Secondary outcomes (2)
Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.
The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).
The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately.
Measured: Day 0
Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H Barton Grossman, Principal investigator, The University of Texas, MD Anderson Cancer Center, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233402
- Sponsor's protocol ID
- PC B305/02
- Status last verified
- Aug 2013
- First submitted
- 4 Oct 2005
- Last updated
- 11 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20850152
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00233402
- Acronym / sponsor ID
- PC B305/02
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Hexvix, Fluorescence, Cystoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Oct 2005 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard White Light Cystoscopy | Active comparator | Procedure: Standard white light cystoscopy |
| Standard White Light and Hexvix Fluorescence Cystoscopy | Experimental | Drug: Hexvix, Procedure: Standard white light cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HexvixSingle Instillation, Transurethral Resection of the Bladder | Drug | Standard White Light and Hexvix Fluorescence Cystoscopy |
| Standard white light cystoscopy | Procedure or surgery | Standard White Light Cystoscopy, Standard White Light and Hexvix Fluorescence Cystoscopy |
Primary outcome
Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light
Time frame: Day 0
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.
Time frame: 9 months
2 secondary outcomes
Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.
Time frame: Day 0
Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20850152Stenzl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H Barton Grossman principal investigator
The University of Texas, MD Anderson Cancer Center, Department of Urology
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hexvix and Standard white light cystoscopy in people with Bladder Cancer, run by Photocure at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, Canada, Netherlands, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00233402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.