Bladder Cancer
Conditions
Keywords
Recurrence of bladder cancer, Fluorescence cystoscopy
Brief summary
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.
Detailed description
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark. Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB
Interventions
DRUGHexvix
Single installation, TURB
Sponsors
Photocure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with suspicion of non-invasive bladder cancer indicated for a transuretheral resection of the bladder * Above 18 years * Written informed consent obtained
Exclusion criteria
* 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). * Conditions associated with a risk of poor protocol compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. | 1 year | To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy. | At day 0 |
| False Positive Detection Rate Patient Level | 12 months |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hexvix Cystoscopy Group | 115 |
| White Light Standard White light cystoscopy | 118 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 9 |
| Overall Study | Protocol Violation | 13 | 1 |
Baseline characteristics
| Characteristic | Hexvix Cystoscopy Group | White Light | Total |
|---|---|---|---|
| Age Continuous | 70.6 years STANDARD_DEVIATION 11.5 | 69.1 years STANDARD_DEVIATION 10 | 69.8 years STANDARD_DEVIATION 10.7 |
| Gender Female | 75 participants | 81 participants | 156 participants |
| Gender Male | 27 participants | 36 participants | 63 participants |
| Region of Enrollment Denmark | 115 participants | 118 participants | 233 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 112 | 8 / 118 |
| serious Total, serious adverse events | 12 / 112 | 4 / 118 |
Outcome results
Primary
Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.
To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.
Time frame: 1 year
Population: PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hexvix Cystoscopy Group | Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. | 30.5 precentage of participants |
| White Light | Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. | 47.3 precentage of participants |
p-value: 0.05Cochran-Mantel-Haenszel
Secondary
False Positive Detection Rate Patient Level
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hexvix Cystoscopy Group | False Positive Detection Rate Patient Level | 25 percent of patients |
| White Light | False Positive Detection Rate Patient Level | 16 percent of patients |
Secondary
Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.
Time frame: At day 0
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hexvix Cystoscopy Group | Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy. | 48.9 percentage of participants |