Trial Outcomes & Findings for Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB (NCT NCT01166230)

NCT ID: NCT01166230

Last Updated: 2019-04-09

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 551 participants
• Primary outcome timeframe: up to 4.5 years
• Results posted on: 2019-04-09

Participant Flow

Participant milestones

Measure	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 PCB305/04 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 PCB305/04 who were followed for recurrence.
Overall Study STARTED	280	271
Overall Study COMPLETED	261	255
Overall Study NOT COMPLETED	19	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patients With Ta/T1, Randomized to White Light Cystoscopy n=280 Participants 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 n=271 Participants 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 n=551 Participants Total of all reporting groups
Age, Continuous	69.6 years STANDARD_DEVIATION 10.68 • n=93 Participants	68 years STANDARD_DEVIATION 10.79 • n=4 Participants	68.8 years STANDARD_DEVIATION 10.76 • n=27 Participants
Sex: Female, Male Female	57 Participants n=93 Participants	59 Participants n=4 Participants	116 Participants n=27 Participants
Sex: Female, Male Male	223 Participants n=93 Participants	212 Participants n=4 Participants	435 Participants n=27 Participants

PRIMARY outcome

Timeframe: up to 4.5 years

Population: Intention-to-treat (ITT)

Outcome measures

Measure	Patients With Ta/T1, Randomized to White Light Cystoscopy n=261 Participants 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 n=255 Participants 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.
Recurrence Free Survival	9.6 months Interval 7.0 to 13.33	16.4 months Interval 11.8 to 25.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients With Ta/T1, Randomized to White Light Cystoscopy n=261 Participants 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 n=255 Participants 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.
Rate of Progression	6.1 percentage of patients	3.1 percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 5.5 years retrospectively

Population: ITT

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.

Outcome measures

Measure	Patients With Ta/T1, Randomized to White Light Cystoscopy n=261 Participants 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 n=255 Participants 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.
Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB	38 percentage of paticipants	31.8 percentage of paticipants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 4.5 years

Population: ITT

Outcome measures

Measure	Patients With Ta/T1, Randomized to White Light Cystoscopy n=261 Participants 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 n=255 Participants 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.
Median Time to Recurrence	9.4 months Interval 6.83 to 12.87	16.4 months Interval 11.0 to 25.0

Adverse Events

Patients With Ta/T1 Randomized to Hexvix Cystoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With Ta/T1, Randomized to White Light Cystoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

H. Barton Grossman, MD

The University of Texas

Phone: 713-563-7456

Email: hbgrossman@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60