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    Clinical Trial Results:
    “Technical and diagnostic performances of PET/CT with 64Cu(II)Cl2 in localization of metastases from prostate carcinoma, in patients undergoing restaging for disease progression during ADT”

    Summary
    EudraCT number
    		 2014-001158-41
    Trial protocol
    		 IT  
    Global end of trial date
    01 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2018
    First version publication date
    11 Apr 2018
    Other versions
    Summary report(s)
    		 Synopsis CSR 2014-001158-41

    Trial information

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    Trial identification
    Sponsor protocol code
    P.64CU.001.01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 n.a: n.a
    Sponsors
    Sponsor organisation name
    Sparkle srl
    Sponsor organisation address
    Contrada Cavallino snc , Montecosaro, (MC), Italy, 62010
    Public contact
    project manager, sparkle srl, 0039 0733229739, p.panichelli@sparklepet.it
    Scientific contact
    project manager, sparkle srl, 0039 0733229739, p.panichelli@sparklepet.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
    01 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Initial assessment of the diagnostic sensibility, on a per-patient-basis, of whole body PET/CT, performed after the administration of 64Cu (II) Cl2, in the localization of metastatic lesions from PCa, of bones, lungs and lymph nodes (regional pelvic and/or lumbar and subfrenic nodes), preliminarly diagnosed on the basis of a Gold Standard surrogate, consisting of the integration of clinical and instrumental methods.
    Protection of trial subjects
    The 64-copper chloride administered was equivalent of about 1-2 micrograms (1-2 millionths of gram, or, if preferred, 1-2 thousandths of milligram) of copper. Therefore, it was injected a maximum quantity equal to 1 / 50,000 of that of all the copper normally present in the organism, equal to 1/750 of that normally assumed daily with food (which is usually 1.5 milligrams / day). The administration of such an amount of copper chloride can not have, as far as it is widely known on the toxicity of copper, any side effects. Based on dosimetry, the biological effect resulting from radiation can be precisely calculated. The radiation dose, biologically effective, associated with the 64-copper-chloride administration provided by the Protocol of Experimentation, is equal to about 20 milliSieverts (the milli-Sievert is a unit of measurement of the biological effect of radiation). However, a certain amount of radiation is also absorbed because of the beam of X ray emitted by the tomograph for the realization of CT images, and, in total, the "effective dose" absorbed by you during the examination will amount to about 32 milliSieverts. This radiation dose is approximately equivalent to two and a half times that attributable to a "whole body" CT, of a diagnostic type, a medical examination performed frequently in the oncological patient.
    Background therapy
    		 all enrolled patients were treated exclusivly with the IMP: 64Cu(II)Cl2/64-Copper Chloride. One single intravenous administration of 64Cu (II) Cl2 with activity equal to MBq = [20x body weight / 4 MBq] +/- 10%, was administrated.No comparators or non-test products were used.
    Evidence for comparator
    		 No comparators were used.
    Actual start date of recruitment
    28 Jun 2016
    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: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    16
    From 65 to 84 years
    33
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 patients are recruited among these groups: Metastatic disease at the onset, diagnosed under staging; radically treated patients due to primary disease, with biochemical relapse, and in which metastases are identified; patients with metastatic disease recognized andmonitored by serial assays of PSA. 51 patients recruited.

    Pre-assignment
    Screening details
    		 age>=50;historical primitive PC;ADT treatment;previous metastatic disease on bone/ lung / lymph node; disease progression/restaging during ADT; whole body CT 20days before;whole body CT within 8months before or MRI or 18F-FCH PET/CT 20days before;no other neoplastic diseases excepted non-melanoma skin cancers;Karnofski’s index >80%

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

    Arms
    Arm title
    		 experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    64CuCl2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single intravenous administration of 64Cu (II) Cl2 with activity equal to: MBq = [20x body weight / 4 MBq] +/- 10%

    Number of subjects in period 1
    		experimental
    Started
    51
    from enrolment to IMP administration
    51
    from IMP administration to followup
    50
    Completed
    50
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall baseline period
    Reporting group description
    		 -

    Reporting group values
    		 overall baseline period Total
    Number of subjects
    		 51 51
    Age categorical
    Patients with metastatic disease at the onset, diagnosed under staging; radically treated patients due to primary disease, which are subject to restaging for BCR, and in which metastases are identified; these patients may be, or not, in ADT at the time of diagnosis of metastatic disease. Patients with metastatic disease recognized and are monitored by serial assays of PSA.
    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)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        adults (50 and over)
    		 51 51
    Age continuous
    Units: years
        median (standard deviation)
    		 68 ( 9 ) -
    Gender categorical
    all the patients were adult male with previous historical diagnosis of primitive prostate carcinoma
    Units: Subjects
        Female
    		 0 0
        Male
    		 51 51

    End points

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    End points reporting groups
    Reporting group title
    experimental
    Reporting group description
    		 -

    Primary: sensitivity of 64Cu(II)Cl2 PET/CT in the localization of metastatic lesions

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    End point title
    		 sensitivity of 64Cu(II)Cl2 PET/CT in the localization of metastatic lesions [1]
    End point description
    Initial assessment of the diagnostic sensibility, on a per patient-basis, of whole body PET/CT after administration of 64Cu(II)Cl2, in the localization of metastatic lesions from PCa, of bones, lungs and lymph nodes (regional pelvic and/or lumbar and subfrenic nodes), preliminary diagnosed on the basis of a Gold Standard surrogate, consisting of the integration of clinical and instrumental methods
    End point type
    Primary
    End point timeframe
    at study completion (Last patient out)
    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: This is a single arm trial and so, as EMA service desk answered (SD-164999) to our question, we can post the results without entering the details of the statistical analysis, since the system cannot currently accommodate one arm study.
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: percentage
    95
    Attachments
    		 primary endpoint results
    No statistical analyses for this end point

    Secondary: Initial assessment on lesion diagnostic sensitivity

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    End point title
    		 Initial assessment on lesion diagnostic sensitivity
    End point description
    the assessment of the lesion-based sensitivity was represented by the numerical ratio between the lesions-index correctly identified by the Observers, and those pre-determined by the Investigator, calculated separately for each anatomic category (bone, lung and lymph node, pelvic bone).
    End point type
    Secondary
    End point timeframe
    at each PET/CT scan at 1hour, 4hours, 24hours from the IMP administration
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: percentage
    97
    Attachments
    		 sensitivity on lesion based results
    No statistical analyses for this end point

    Secondary: image quality analysis based on Target/Background

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    End point title
    		 image quality analysis based on Target/Background
    End point description
    The evaluation of the "target/background" ratio (T/B) is based on the measurement of: 1. the value of max SUV detected at the PET/CT in all the "index, bone, pulmonary and pelvic lymph nodes", with high diagnostic confidence, previously identified by the Investigator, in each examined subject. 2. the SUV max value of the average mm.glute of each side, and calculation of the mean and of the SUV max value of the mediastinum higher than the origin of the large vessels and in presence of pulmonary uptake sites: SUV max value of pulmonary tissue against lateral to the lesion, if free from alterations, or of free lung tissue, contralateral or homolateral to the lesion, at the same anatomical level in the height organ. 3. the T/B value as SUV max ratio (lesion)/SUV max (background), for each scan b. For lymph node metastases: SUV ratio max mts/SUV max mediastinum, c. For pulmonary metastases: SUV ratio max mts/SUVmax lung versus lateral 4.T/B index trend can be represented in graph
    End point type
    Secondary
    End point timeframe
    at each PET/CT scan at 1hour, 4hours, 24hours from the IMP administration
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: continuos variable
        arithmetic mean (standard deviation)
    5.4 ( 5.68 )
    Attachments
    		 Target to background results
    No statistical analyses for this end point

    Secondary: intra observer diagnostic reproducibility

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    End point title
    		 intra observer diagnostic reproducibility
    End point description
    Evaluation of intra-observer diagnostic reproducibility has been obtained verifying the fraction of concordant diagnosis (and the relative limits of confidence), expressed by the same Observer, when the same scan has been proposed again to the Observer, for the second time, at variable distance from the first one. Intra-observer reproducibility was analyzed for both patient-based and base-lesion analysis.
    End point type
    Secondary
    End point timeframe
    at trial completition
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: percentage
    100
    Attachments
    		 intra-observer diagnostic reproducibility
    No statistical analyses for this end point

    Secondary: inter observer diagnostic reproducibility

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    End point title
    		 inter observer diagnostic reproducibility
    End point description
    inter-observer reproducibility was evaluated by the concordance of each of the diagnostic readings randomly submitted to each Observer, with reference to the equivalent readings made by the other two Observers. The analysis was performed both on a patient-based and on a lesion basis, and expressed by calculating the Cohen k index (and the related confidence limits) using the "bootstrap block" method.
    End point type
    Secondary
    End point timeframe
    covered all the trial period included the PET/CT scans analysis by the observers
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: percentage
    95
    Attachments
    		 inter-observer diagnostic reproducibility
    No statistical analyses for this end point

    Secondary: optimization of post injection times

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    End point title
    		 optimization of post injection times
    End point description
    The definition of the optimal post-injective time for the execution of the 64Cu (II) Cl2 PET / CT examination in terms of: • Maximization the sensitivity of the patient-based methodology, • Maximization of the sensitivity of the method on a lesion basis, • Target-to-background contrast maximization, • Maximization of intra-observer diagnostic reproducibility (on a patient-based and on a lesion-based ), • Maximization of inter-observer diagnostic reproducibility (on a patient-based and on a lesion-based). This implies the definition of the aforementioned parameters independently for each of the post-injection scan times that were performed (1, 4 and 24 hours after IMP administration).
    End point type
    Secondary
    End point timeframe
    1, 4 and 24 hours after IMP administration
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: percentage
    95
    Attachments
    		 optimal scan time
    No statistical analyses for this end point

    Secondary: safety profile

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    End point title
    		 safety profile
    End point description
    evaluation of the frequency and of the clinical importance, as well as of the possible causality relationship with the administration of the IMP of the adverse events,
    End point type
    Secondary
    End point timeframe
    from IMP administration to last patient last visit at day 10 since IMP administration
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: percentage
    0
    Attachments
    		 safety profile results
    No statistical analyses for this end point

    Secondary: kinetic of IMP

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    End point title
    		 kinetic of IMP
    End point description
    The Investigator, performed the PET / CT examination for each subject, to calculate the absorbed dose, has manually outlined volumes of interest (VOI) on the organs whose kinetics were to be evaluated (tumor, surrounding tissue, liver, kidney, region vertebral-lumbar and soft tissues) and dosimetry directly using PET / CT coregistered images (both at 1h and at 4h and 24h from the injection). For these organs the masses were calculated and, from the quantification of the activity through the study of the kinetic, the cumulative activity. Using the Olinda / EXM program the S factor for the various organs was calculated. Therefore, using the MIRD (Medical Internal Radiation Dose) formalism, for the organs of greatest dosimetric interest, depending on the activity administered, the absorbed dose will be calculated.
    End point type
    Secondary
    End point timeframe
    at 1h and at 4h and 24h from the injection
    End point values
    		 experimental
    Number of subjects analysed
    50
    Units: mGy/MBq
        arithmetic mean (standard deviation)
    5.4 ( 5.68 )
    Attachments
    		 kinetics evaluation
    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 reporting started since the administration of the IMP to the last safety follow-up after 10 days.
    Adverse event reporting additional description
    AE were collected during the follow up visits at 4hours, 24 hours and 10 days from the IMP administration and at any time by self-reporting signaling by the patient. no AE has been verified during the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    AE reporting group
    Reporting group description
    		 All the subjects who received the IMP dose (total 50 patients) were included in the AE reporting Group (50 patients).

    Serious adverse events
    		 AE reporting group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 AE reporting group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    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: Due to the short period of the trial, 10 days from IMP administration to the last followup visit, no adverse events occured

    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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