Bladder Cancer
Conditions
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.
Interventions
None listed
Sponsors
Photocure
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence Free Survival | up to 4.5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Median Time to Recurrence | up to 4.5 years | — |
Countries
Austria, Canada, Germany, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 280 |
| 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. | 271 |
| Total | 551 |
Baseline characteristics
| Characteristic | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy | Total |
|---|---|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 10.68 | 68 years STANDARD_DEVIATION 10.79 | 68.8 years STANDARD_DEVIATION 10.76 |
| Sex: Female, Male Female | 57 Participants | 59 Participants | 116 Participants |
| Sex: Female, Male Male | 223 Participants | 212 Participants | 435 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Recurrence Free Survival
Time frame: up to 4.5 years
Population: Intention-to-treat (ITT)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Ta/T1, Randomized to White Light Cystoscopy | Recurrence Free Survival | 9.6 months |
| Patients With Ta/T1 Randomized to Hexvix Cystoscopy | Recurrence Free Survival | 16.4 months |
p-value: 0.056Wilcoxon (Mann-Whitney)
Secondary
Rate of Progression
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Ta/T1, Randomized to White Light Cystoscopy | Rate of Progression | 6.1 percentage of patients |
| Patients With Ta/T1 Randomized to Hexvix Cystoscopy | Rate of Progression | 3.1 percentage of patients |
Other Pre-specified
Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB
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
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Ta/T1, Randomized to White Light Cystoscopy | Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB | 38 percentage of paticipants |
| Patients With Ta/T1 Randomized to Hexvix Cystoscopy | Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB | 31.8 percentage of paticipants |
p-value: 0.141Fisher Exact
Other Pre-specified
Median Time to Recurrence
Time frame: up to 4.5 years
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Ta/T1, Randomized to White Light Cystoscopy | Median Time to Recurrence | 9.4 months |
| Patients With Ta/T1 Randomized to Hexvix Cystoscopy | Median Time to Recurrence | 16.4 months |
p-value: 0.041Wilcoxon (Mann-Whitney)