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    Clinical Trial Results:
    Diagnostic and clinical value of fused 64CuCl2-PET/MRI in prostate cancer relapse. Comparison with multiparametric MRI (mMRI) and 18F-Choline-PET/MRI

    Summary
    EudraCT number
    		 2014-005140-18
    Trial protocol
    		 IT  
    Global end of trial date
    31 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2021
    First version publication date
    28 Jul 2021
    Other versions
    Summary report(s)
    		 Diagnostic value of retrospectively fused 64CuCl2 PET/MRI in biochemical relapse of prostate cancer: comparison with fused 18F‑Choline PET/MRI, 64CuCl2 PET/CT, 18F‑Choline PET/CT, and mpMRI
    64CuCl2 PET/CT in Prostate Cancer Relapse
    Biokinetic and dosimetric aspects of 64CuCl2 in human prostate cancer: possible theranostic implications

    Trial information

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    Trial identification
    Sponsor protocol code
    RAME-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Rame01: 30UCS2014
    Sponsors
    Sponsor organisation name
    E.O. Ospedali Galliera
    Sponsor organisation address
    Mura delle Cappuccine 14, Genoa, Italy, 16128
    Public contact
    Ufficio del Coordinatore Scientifico, E.O.Ospedali Galliera - Genova, 0039 0105634235, ucs@galliera.it
    Scientific contact
    Ufficio del Coordinatore Scientifico, E.O.Ospedali Galliera - Genova, 0039 0105634235, ucs@galliera.it
    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
    31 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was firstly to assess the diagnostic performance of fused 64CuCl2-PET/MRI in patients with suspected relapse of prostate cancer after surgery or EBRT. In addition we want to compare the accuracy of fused 64CuCl2-PET/MRI with that of mMRI,18F-Choline-PET/MRI, 18F-Choline-PET/CT, and contrast enhanced CT in detecting local recurrence, lymph node, and bone metastases
    Protection of trial subjects
    To evaluate the potential hepatic radiotoxicity of64CuCl2adminis-tration, according to Agenzia Italiana del Farmaco suggestions, bloodtests were performed on all patients and used to determine the follow-ing parameters: hematocrit, hemoglobin, C-reactive protein, aspartatetransaminase, alanine transaminase, alkaline phosphatase, albumin,total bilirubin,g-glutamyl transferase, lactate dehydrogenase, totalproteins, serum creatinine, and azotemia. The tests were performedimmediately before radiopharmaceutical administration and 10 d afterthe first64CuCl2whole-body scan.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2015
    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
    Italy: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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
    31
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Prostate Cancer patients presenting biochemical relapse after first-line surgery or EBRT

    Pre-assignment
    Screening details
    		 Principal inclusion criteria (up to 4000 characters)(Criteri di inclusione principali, in inglese): -years > 18 -all histologically proven prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy -Gleason score ≥6, -increasing levels of PSA and PSA doubling time (DT) ≤6 months. -Informed

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

    Arms
    Arm title
    		 prostate cancer relapse group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    64CuCl2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    6,7 mCi millicurie(s)

    Number of subjects in period 1
    		prostate cancer relapse group
    Started
    50
    Completed
    50

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    prostate cancer relapse group
    Reporting group description
    		 -

    Subject analysis set title
    diagnostic accuracy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    PCapatients with biochemical relapse after surgery or external-beam radiation therapy

    Primary: detection rate (DR) of 64CuCl2 PET/CT

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    End point title
    		 detection rate (DR) of 64CuCl2 PET/CT [1]
    End point description
    End point type
    Primary
    End point timeframe
    Time frame: From February to October 2016
    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: DRs were calculated as the ratio between the number of positive patients (or lesions in the case of lesion-based analysis) and the total number of patients enrolled (or lesions).
    End point values
    		 diagnostic accuracy
    Number of subjects analysed
    50
    Units: percentage
    41
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The adverse event will be notified to the Galliera pharmacovigilance contact person within 24 hours from when the principal investigator became aware of it and that subsequent relevant information will be communicated within eight days of the first report
    Adverse event reporting additional description
    No adverse events were observed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Adverse Events No drug-related pharmacologic effects or physiologic responsesoccurred. No adverse reactions were observed after the injection of 64CuCl2. All observed parameters (i.e., blood pressure, heart rate, body temperature) remained normal and unchanged during and after the examination. No patient reported subjective symptoms. In addition, no modification of the above-mentioned blood tests was reported 10 d after 64CuCl2 injection.

    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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