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    Clinical Trial Results:
    A Phase III Clinical Trial to evidence the safety and efficacy of the radio-drug 18f-Fluorocholine (18F-FCH), using Positron Emission Tomography (PET) for the diagnosis of the prostate carcinoma in patients with biochemical relapse.

    Summary
    EudraCT number
    		 2013-004397-99
    Trial protocol
    		 ES  
    Global end of trial date
    30 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2018
    First version publication date
    11 Jul 2018
    Other versions
    Summary report(s)
    		 CSR in Spanish

    Trial information

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    Trial identification
    Sponsor protocol code
    MBCC28040
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto Tecnológico PET, S.A.U. (ITP)
    Sponsor organisation address
    Calle de Manuel Bartolomé Cossío, 10, Madrid, Spain, 28040
    Public contact
    Emilio Viñas Navarro, Instituto Tecnológico PET, S.A.U. (ITP), 34 915344896135, evinas@petmadrid.com
    Scientific contact
    Emilio Viñas Navarro, Instituto Tecnológico PET, S.A.U. (ITP), 34 915344896135, evinas@petmadrid.com
    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
    16 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the diagnostic efficiency in terms of the classification probabilities (sensitivity and specificity) of the PET CT with 18F-FCH in demonstrating the recurrence of prostate cancer in patients with biochemical relapse who have undergone radical primary treatment, using as reference standard the histology of the lesions (in some cases the confirmation of the diagnosis can be made with clinical follow-up)
    Protection of trial subjects
    The Sponsor of the study has an insurance policy that conforms to current legislation (Royal Decree 223/2004 of February 6, which regulates clinical trials with drugs), which will provide compensation in case of impairment of your health or injuries that may occur in connection with your participation in the study. This policy is contracted with Catlin Europe S.E Iberia Branch, with policy number CE3000414697 In case medical care is needed, the costs incurred for this are the responsibility of the Sponsor.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2014
    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
    Spain: 114
    Worldwide total number of subjects
    114
    EEA total number of subjects
    114
    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)
    15
    From 65 to 84 years
    95
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 End of recruitment dated on October 06, 2015 The first patient was recruited on November 7, 2014 so the period of recruitment lasted 11 months

    Pre-assignment
    Screening details
    		 1.Male.2.Age≥18 years.3. Patients with biochemical relapse of Prostate Carcinoma who have reached any of the following serum PSA levels after a previous primary radical treatment: In patient treated with radical prostatectomy must have passed at least 3 months from the urgery and PSA value will be: (a) higher than 1.0 ng / mL. Continue in Protocol.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment (baseline)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]-fluorometilcolina; [18F]-fluorocolina; 18F-FCH. COLTRACER
    Investigational medicinal product code
    V09IX07
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Half-life of the radioisotope: 110 minutes. - Dose: 4.0 MBq per kg body weight

    Arm title
    		 Treatment (end data)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    [18F]-fluorometilcolina; [18F]-fluorocolina; 18F-FCH. COLTRACER
    Investigational medicinal product code
    V09IX07
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    - Half-life of the radioisotope: 110 minutes. - Dose: 4.0 MBq per kg body weight

    Number of subjects in period 1
    		Treatment (baseline) Treatment (end data)
    Started
    57
    57
    Completed
    57
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment (baseline)
    Reporting group description
    		 -

    Reporting group title
    Treatment (end data)
    Reporting group description
    		 -

    Reporting group values
    		 Treatment (baseline) Treatment (end data) Total
    Number of subjects
    		 57 57 114
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 7 8 15
        From 65-84 years
    		 48 47 95
        85 years and over
    		 2 2 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.9 ± 6.5 71.9 ± 6.5 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 57 57 114
    Subject analysis sets

    Subject analysis set title
    Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment arm (baseline)

    Subject analysis set title
    Treatment (end data)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment (end data)

    Subject analysis sets values
    		 Treatment Treatment (end data)
    Number of subjects
    57
    57
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    7
    8
        From 65-84 years
    48
    47
        85 years and over
    2
    2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    71.9 ± 6.5
    71.9 ± 6.5
    Gender categorical
    Units: Subjects
        Female
    0
    0
        Male
    57
    57

    End points

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    End points reporting groups
    Reporting group title
    Treatment (baseline)
    Reporting group description
    		 -

    Reporting group title
    Treatment (end data)
    Reporting group description
    		 -

    Subject analysis set title
    Treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment arm (baseline)

    Subject analysis set title
    Treatment (end data)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment (end data)

    Primary: Diagnostic efficiency of the PET-CT on an individual level

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    End point title
    		 Diagnostic efficiency of the PET-CT on an individual level
    End point description
    The corresponding specialist will consider the test positive if there is evidence of abnormal catchment in any location under evaluation. Likewise, the reference compare will be positive if there is evidence of a clinical relapse in any location.
    End point type
    Primary
    End point timeframe
    All imaging tests evaluated in the study objectives will be performed within the period of 15 days before or after the PET-TC with 18f-FCH has been performed.
    End point values
    		 Treatment (baseline) Treatment (end data) Treatment Treatment (end data)
    Number of subjects analysed
    57
    57
    57
    57
    Units: percentage
    83
    83
    83
    83
    Statistical analysis title
    		 PET-TC efficiency
    Statistical analysis description
    SAS v9.1
    Comparison groups
    Treatment (baseline) v Treatment (end data)
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 > 0.05 [2]
    Method
    		 t-test, 1-sided
    Parameter type
    		 diagnostic yield
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.9479
    Variability estimate
    Standard deviation
    Notes
    [1] - The diagnostic performance of PET-CT was evaluated at the individual level. The test was considered positive if abnormal uptake was evidenced in any location assessed by the corresponding specialists. The reference pattern was positive if the presence of clinical recurrence was evidenced in any location. We calculated empirical estimates of the classification probabilities (TPF, FPF), and their 95% two-dimensional confidence region, using exact methods based on the binomial distribution.
    [2] - Evaluation of the sensitivity and specificity of PET-CT with 18F-FCH in the demonstration of clinical recurrence of prostate cancer in patients with biochemical recurrence, using the histology of the lesions as a reference standard (binomial distr.)

    Secondary: Secondary endpoints

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    End point title
    		 Secondary endpoints
    End point description
    1.-Demonstration, in separate, of the clinical relapses, local-regional and at distance. 2. - Evaluate the impact of the PET-CT over the reasonable diagnostic. 3. - Evaluate the secondary objectives related to the accuracy of the diagnostic with other imaging technics (CT with contrast, MRI and bone gamagraphy). 4. - Evaluate the influence of several factors over the efficiency of the diagnostic with PET-CT. 5.- Complete empiric estimations for the ROC curve. 6.- Analyze the safety of the radio tracer.
    End point type
    Secondary
    End point timeframe
    During the performance of the imaging test. During the following 24 hours to the performance of the image test. During each patient's participation in the study (except those occurring in the course of the image test or within the following 24 hours)
    End point values
    		 Treatment (baseline) Treatment (end data) Treatment Treatment (end data)
    Number of subjects analysed
    57
    57
    57
    57
    Units: Percentage
    83
    83
    83
    83
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any AE, or any abnormal laboratory result that was considered clinically relevant, was followed until a satisfactory resolution was reached, until it was stabilized, or until it could be explained by other causes.
    Adverse event reporting additional description
    All AEs were registered in the e-CRF, accompanied by the following information: • Nature of AE • When the AE occurred for the first time (beginning). • When the AE ended and / or how long it lasted. • If the AE was serious. • Intensity of the AE. • Measures taken. • Final (or last known) ending. • Relationship with IMP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 114 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 114 (0.88%)
    Social circumstances
    Alopecia
         subjects affected / exposed
    1 / 114 (0.88%)
         occurrences all number
    1

    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
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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