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    Clinical Trial Results:
    TREATMENT OF Ta BLADDER CANCER WITH HIGH RISK OF RECURRENCE – FLUORESCENCE CYSTOSCOPY WITH OPTIMIZED ADJUVANT MITOMYCIN-C

    Summary
    EudraCT number
    		 2012-000559-15
    Trial protocol
    		 FI  
    Global end of trial date
    01 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2024
    First version publication date
    21 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FB2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01675219
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FinnBladder
    Sponsor organisation address
    Sairaalakatu 1, Vantaa, Finland, 05850
    Public contact
    FinnBladder office, FinnBladder, +358 9471 66681, aini.salo@hus.fi
    Scientific contact
    FinnBladder office, FinnBladder, +358 9471 66681, aini.salo@hus.fi
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To evaluate whether the adjuvant 6-weekly optimized MMC instillation therapy is better than single immediate postoperative instillation therapy in reducing recurrences. 2) To evaluate whether the PDD-guided TUR-BT is better than the conventional white light TUR-BT in reducing recurrence, which implies evaluation of whether the effect of PDD-guided TUR-BT is additive to MMC instillation therapy
    Protection of trial subjects
    Every patient will be informed about the modalities in accordance with the enclosed patient information sheet. The patient is informed both in writing and verbally by the physician. The patient must have the opportunity to decide whether or not to participate in the clinical trial. The explanatory information includes the following points: -nature of the disease -general prognosis -presently available diagnostic procedures -type and aims of the clinical study -information on the substance to be tested -effects and side effects of therapy to be expected -laboratory and clinical tests to be performed -regulations regarding confidentiality and divulgence of information -possible review of patient data by the authorities -storage of data -duties of the patient (no specific duties) Both the informing physician and the patient must sign a declaration of consent. The patient will retain a copy of the declaration. The declarations of consent are part of the patient file and will be retained with this.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 510
    Worldwide total number of subjects
    510
    EEA total number of subjects
    510
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    108
    From 65 to 84 years
    380
    85 years and over
    22

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of patients was performed in Finland. Recruitment was done during the period of 13.12.2022-29.4.2022.

    Pre-assignment
    Screening details
    		 Subjects were identified in academic urological centers and reviewed or eligibility

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Patients with TUR-­‐BT performed under white light, followed by a single instillation of epirubicin.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group B
    Arm description
    		 Patients with TUR-­‐BT performed using PDD, followed by a single instillation of epirubicin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexvix
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Bladder irrigation
    Routes of administration
    Intravesical use
    Dosage and administration details
    85 mg milligrams intravesically

    Arm title
    		 Group C
    Arm description
    		 Patients with TUR-­‐BT performed under white light, followed by a single instillation of epirubicin plus six optimized MMC instillations
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mitostat
    Investigational medicinal product code
    PR2
    Other name
    Pharmaceutical forms
    Bladder irrigation
    Routes of administration
    Intravesical use
    Dosage and administration details
    40 mg milligrams intravesically

    Arm title
    		 Group D
    Arm description
    		 Patients with TUR-­‐BT performed using PDD, followed by a single instillation of epirubicin plus six optimized MMC instillations
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexvix
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Bladder irrigation
    Routes of administration
    Intravesical use
    Dosage and administration details
    85 mg milligrams intravesically

    Investigational medicinal product name
    Mitostat
    Investigational medicinal product code
    PR2
    Other name
    Pharmaceutical forms
    Bladder irrigation
    Routes of administration
    Intravesical use
    Dosage and administration details
    40 mg milligrams intravesically

    Number of subjects in period 1
    		Group A Group B Group C Group D
    Started
    126
    127
    127
    130
    Completed
    59
    69
    56
    70
    Not completed
    67
    58
    71
    60
         no cancer or high grade cancer on histopathology
    67
    58
    71
    60

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients with TUR-­‐BT performed under white light, followed by a single instillation of epirubicin.

    Reporting group title
    Group B
    Reporting group description
    		 Patients with TUR-­‐BT performed using PDD, followed by a single instillation of epirubicin.

    Reporting group title
    Group C
    Reporting group description
    		 Patients with TUR-­‐BT performed under white light, followed by a single instillation of epirubicin plus six optimized MMC instillations

    Reporting group title
    Group D
    Reporting group description
    		 Patients with TUR-­‐BT performed using PDD, followed by a single instillation of epirubicin plus six optimized MMC instillations

    Primary: Bladder cancer recurrence

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    End point title
    		 Bladder cancer recurrence [1]
    End point description
    End point type
    Primary
    End point timeframe
    Analysis of time to From randomisation to recurrence or to last follow-up date.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Preparing final publication and data available after publication
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    59
    69
    56
    70
    Units: occurrence of biopsy confirmed Ta-­‐1 tu
    7
    13
    11
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall trial 13.12.2012-1.11.2024
    Adverse event reporting additional description
    As this was academic, investigator initiated trial investigating authorised products in routine clinical use, no formal monitoring was carried out
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Preparing final publication and data available after publication

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31177305
    http://www.ncbi.nlm.nih.gov/pubmed/35094962
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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