Clinical Trial Results:
Photodynamic diagnosis (PDD) in flexible cystoscopy – a randomized study with focus on significant recurrence
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Summary
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EudraCT number |
2015-000436-15 |
Trial protocol |
DK |
Global end of trial date |
14 Dec 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Jan 2021
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First version publication date |
13 Jan 2021
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Other versions |
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Summary report(s) |
DaBlaCa11 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DD-study-3
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Aarhus University Hospital
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Sponsor organisation address |
Palle Juul-Jensens Blvd. 35, Aarhus N, Denmark, 8200
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Public contact |
Jørgen Bjerggaard Jensen, Aarhus Universitets Hospital, 0045 78452617, Bjerggaard@skejby.rm.dk
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Scientific contact |
Jørgen Bjerggaard Jensen, Aarhus Universitets Hospital, 0045 78452617, Bjerggaard@skejby.rm.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Dec 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Dec 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Dec 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The Hypothesis of this study is that the use of PDD in the outpatient clinic in patients with a high recurrence risk undergoing follow-up flexible cystoscopy will result in diagnosis of papillomas earlier than by the use of conventional flexible cystoscopy in white light. Thus, a higher number of tumours can be treated in the outpatient setting without the need for procedures in general anaesthesia. Furthermore, the number of follow-up cystoscopies can be reduced if PDD is used at the first cystoscopy following TURB.
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Protection of trial subjects |
Trial Subjects in the intervention arm underwent instillation of Hexaminolevulinate (HAL) prior to the cystoscopy using local anesthesia (Lidocaine gel).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2015
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
2 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 696
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Worldwide total number of subjects |
696
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EEA total number of subjects |
696
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
696
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
FVFS: Feb. 2016. LVLS: Dec. 2017 | |||||||||
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Pre-assignment
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Screening details |
Pre-screened: 1130/ Excluded: 431 351 patients were allocated to the intervention group (flexible PDD), and 348 to the control group (flexible white light). Throughout the following 8 months after randomization, only 117 patients in the intervention group had at least 1 tumor recurrence compared to 143 patients in the control group | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
696 | |||||||||
Number of subjects completed |
696 | |||||||||
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Period 1
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Period 1 title |
Inclusion (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | |||||||||
Arm description |
Intervention group (hexaminolevulinate was instilled in the bladder before flexible cystoscopy with PDD video cystoscope) | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
hexaminolevulinate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for intravesical solution
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Routes of administration |
Intravesical use
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Dosage and administration details |
Hexvix 85 mg
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Arm title
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Control | |||||||||
Arm description |
Control group (white light flexible cystoscope), only. | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Intervention group (hexaminolevulinate was instilled in the bladder before flexible cystoscopy with PDD video cystoscope) | ||
Reporting group title |
Control
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Reporting group description |
Control group (white light flexible cystoscope), only. | ||
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End point title |
Tumor recurrence within 8 months from the randomization | ||||||||||||
End point description |
Use of PDD in a routine surveillance cystoscopy first time after transurethral resection of bladder
tumor for nonmuscle invasive bladder cancer reduces subsequent risk of tumor recurrence compared
to WL cystoscopy alone.
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End point type |
Primary
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End point timeframe |
Feb. 2016 - Dec. 2017
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Statistical analysis title |
Analysis | ||||||||||||
Comparison groups |
Control v Intervention
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Number of subjects included in analysis |
696
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Regression, Logistic | ||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||
Point estimate |
0.67
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.48 | ||||||||||||
upper limit |
0.95 | ||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
0.05
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Adverse events information [1]
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Timeframe for reporting adverse events |
Feb. 2016 - Dec. 2017
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
22
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The trial subjects in both groups had to undergo the same procedure e.g. cystoscopy with expected post mikro/ makro haematuria when voiding the first 24 hours after the procedure. As for the intervention group who had to undergo catheterization prior to the cystoscopy post mikro/ makro haematuria is also expected. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
