An observational study in Bladder Cancer, sponsored by Photocure. Completed at 24 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-09.
Sponsored by Photocure · Observational
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.
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 551 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Photocure is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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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.
Exclusion Criteria:
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.
Recurrence Free Survival
Time frame: up to 4.5 years
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
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
Median Time to Recurrence
Time frame: up to 4.5 years
| Milestone | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy |
|---|---|---|
| Started | 280 | 271 |
| Completed | 261 | 255 |
| Not completed | 19 | 16 |
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.
| percentage of paticipants | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy |
|---|---|---|
| Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB | 38 | 31.8 |
| months | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy |
|---|---|---|
| Median Time to Recurrence | 9.4 (6.83 to 12.87) | 16.4 (11 to 25) |
| months | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy |
|---|---|---|
| Recurrence Free Survival | 9.6 (7.00 to 13.33) | 16.4 (11.8 to 25.00) |
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.
| percentage of patients | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy |
|---|---|---|
| Rate of Progression | 6.1 | 3.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Ta/T1 Randomized to Hexvix Cystoscopy | — | — | — |
| Patients With Ta/T1, Randomized to White Light Cystoscopy | — | — | — |
| Age, Continuous(years) | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy | Total |
|---|---|---|---|
| Mean | 69.6 ± 10.68 | 68 ± 10.79 | 68.8 ± 10.76 |
| Sex: Female, Male(Participants) | Patients With Ta/T1, Randomized to White Light Cystoscopy | Patients With Ta/T1 Randomized to Hexvix Cystoscopy | Total |
|---|---|---|---|
| Female | 57 | 59 | 116 |
| Male | 223 | 212 | 435 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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