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

• Sponsor: Photocure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01166230
• Collaborator: (none)
• Enrollment: 551
• Locations: 24
• Duration (Months): 6
• Patients Per Site: 23
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer

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 Design

• Study Type: Observational
• Actual Enrollment: 551 participants
• Observational Model: Other
• Time Perspective: Retrospective
• 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
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Recurrence Free Survival [up to 4.5 years]

Secondary Outcome Measures

1. 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.

Other Outcome Measures

1. Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB [up to 5.5 years retrospectively]

   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.

2. Median Time to Recurrence [up to 4.5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Cancer Center, Department of Urology	Stanford	California	United States	94305-5820
2	V.A. Medical Center	Gainesville	Florida	United States	32608
3	University of Miami School of Medicine	Miami	Florida	United States	33136
4	South Florida Clinical Research Center, Inc.	Pembroke Pines	Florida	United States	33028
5	The Emory Clinic, Dept of Urology	Atlanta	Georgia	United States	30322
6	Boston University School of Medicine	Boston	Massachusetts	United States	02118
7	Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
8	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
9	Mount Sinai Medical Center, Department of Urology	New York	New York	United States	10029-6574
10	URMC	Rochester	New York	United States	14642
11	Thomas Jefferson Medical College, Department of Neurology	Philadelphia	Pennsylvania	United States	19107
12	Vanderbilt University Medical Center, Department of Urologic Surgery	Nashville	Tennessee	United States	37232-2765
13	Baylor College of Medicine, Scott Department of Urology	Houston	Texas	United States	77030-2726
14	The University of Texas MD Anderson cancer center	Houston	Texas	United States	77030-4009
15	AKH, Klinik für Urologie der Universität Wien	Wien		Austria	1090
16	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
17	CHUQ Hotel-Dieu de Quebec	Quebec		Canada	G1R 2J6
18	University Clinic of Giessen, Department of Urology	Giessen		Germany	35392
19	Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik	München		Germany	81377
20	Urologische Klinik München-Planegg	Planegg		Germany	82152
21	Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie	Regensburg		Germany	93053
22	Universitätsklinik Tuebingen, Universitätsklinik für Urologie	Tuebingen		Germany	72076
23	Department of Urology, Academic Medical Center, University of Amsterdam	Amsterdam		Netherlands	1105 AZ
24	Department of Urology, UMC St. Radboud	Nijmegen		Netherlands	6500 HB

Sponsors and Collaborators

• Photocure

Investigators

• Principal Investigator: Herbert Barton Grossman, MD, The University of Texas MD Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Bladder Cancer Advocacy Network (BCAN)

Publications

None provided.

• Responsible Party: Photocure
• ClinicalTrials.gov Identifier: NCT01166230
• Other Study ID Numbers: PC B305/E10
• First Posted: Jul 20, 2010
• Last Update Posted: Apr 9, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Recurrence

Study Results

Participant Flow

Arm/Group Title	Patients With Ta/T1, Randomized to White Light Cystoscopy	Patients With Ta/T1 Randomized to Hexvix Cystoscopy
Arm/Group Description	Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.	Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
Period Title: Overall Study
STARTED	280	271
COMPLETED	261	255
NOT COMPLETED	19	16

Baseline Characteristics

Arm/Group Title	Patients With Ta/T1, Randomized to White Light Cystoscopy	Patients With Ta/T1 Randomized to Hexvix Cystoscopy	Total
Arm/Group Description	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 non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.	Total of all reporting groups
Overall Participants	280	271	551
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.6 (10.68)	68 (10.79)	68.8 (10.76)
Sex: Female, Male (Count of Participants)
Female	57 20.4%	59 21.8%	116 21.1%
Male	223 79.6%	212 78.2%	435 78.9%

Outcome Measures

1. Other Pre-specified Outcome

Title	Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB
Description	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.
Time Frame	up to 5.5 years retrospectively

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Patients With Ta/T1, Randomized to White Light Cystoscopy	Patients With Ta/T1 Randomized to Hexvix Cystoscopy
Arm/Group Description	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 non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
Measure Participants	261	255
Number [percentage of paticipants]	38	31.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients With Ta/T1, Randomized to White Light Cystoscopy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.141
	Comments
	Method	Fisher Exact
	Comments

2. Other Pre-specified Outcome

Title	Median Time to Recurrence
Time Frame	up to 4.5 years

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Patients With Ta/T1, Randomized to White Light Cystoscopy	Patients With Ta/T1 Randomized to Hexvix Cystoscopy
Arm/Group Description	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 non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
Measure Participants	261	255
Median (95% Confidence Interval) [months]	9.4	16.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients With Ta/T1, Randomized to White Light Cystoscopy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.041
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Recurrence Free Survival
Time Frame	up to 4.5 years

Outcome Measure Data

Analysis Population Description

Intention-to-treat (ITT)

Arm/Group Title	Patients With Ta/T1, Randomized to White Light Cystoscopy	Patients With Ta/T1 Randomized to Hexvix Cystoscopy
Arm/Group Description	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 non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
Measure Participants	261	255
Median (95% Confidence Interval) [months]	9.6	16.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients With Ta/T1, Randomized to White Light Cystoscopy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.056
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Rate of Progression
Description	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.
Time Frame	4.5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients With Ta/T1, Randomized to White Light Cystoscopy	Patients With Ta/T1 Randomized to Hexvix Cystoscopy
Arm/Group Description	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 non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
Measure Participants	261	255
Number [percentage of patients]	6.1	3.1

Adverse Events

Adverse Event Reporting Description	There was no treatment in this clinical study, only a follow-up of previously treated patients, so assessment of safety was not applicable.
Arm/Group Title	Patients With Ta/T1 Randomized to Hexvix Cystoscopy		Patients With Ta/T1, Randomized to White Light Cystoscopy
Arm/Group Description	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.
All Cause Mortality
	Patients With Ta/T1 Randomized to Hexvix Cystoscopy		Patients With Ta/T1, Randomized to White Light Cystoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Patients With Ta/T1 Randomized to Hexvix Cystoscopy		Patients With Ta/T1, Randomized to White Light Cystoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Patients With Ta/T1 Randomized to Hexvix Cystoscopy		Patients With Ta/T1, Randomized to White Light Cystoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.