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    Clinical Trial Results:
    Qualification of 82Rb PET for measurement of tumor perfusion. Uptake in primary prostate cancer vs healthy prostate

    Summary
    EudraCT number
    		 2016-003185-26
    Trial protocol
    		 DK  
    Global end of trial date
    11 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2016-NUK-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital, Dept. of Nuclearmedicine & PET
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Århus N, Denmark, 8200
    Public contact
    Dept. of Nuclearmedicine & PET, Aarhus University Hospital, 0045 78456210, madsjoch@rm.dk
    Scientific contact
    Dept. of Nuclearmedicine & PET, Aarhus University Hospital, 0045 78456210, madsjoch@rm.dk
    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
    11 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    It is well known that blood flow in tumors are higher than in healthy tissue. The main objective of the trial is to prove that the increased blood flow in tumors can be detected by the PET flow tracer 82Rb. In this project we examine the prostate.
    Protection of trial subjects
    None (None needed)
    Background therapy
    		 None
    Evidence for comparator
    		 The healthy controls have normal PSA values and no known disease of the prostate.
    Actual start date of recruitment
    01 Oct 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
    Denmark: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    12
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The 15 patients with prostate cancer were recruited in relation to a clinical 68Ga-PSMA PET/CT scan. The 15 controls were recruited in relation to a clinical 82Rb PET/CT myocardial perfusion scan. The controls had a PSA blood sample taken and were asked about symptoms from lower urinary tract and known prostate disease.

    Pre-assignment
    Screening details
    		 The patients had high risk prostate cancer and no other known malignancies. The controls had a PSA blood sample taken and were asked about symptoms from lower urinary tract and no known prostate disease and no other known malignancies.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Patients with prostate cancer
    Arm description
    		 High risk prostate cancer patients
    Arm type
    		 Patients with prostate cancer - scanned

    Investigational medicinal product name
    Cardiogen-82
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Radiopharmaceutical diagnostics. The Cardiogen-82 generator can eluate a new dosage of Rubidium-82 every 10 minutes for directly infusion in the patient. The dosage of radioactivity is approximately 1110 MBq.

    Arm title
    		 Healthy controls
    Arm description
    		 Men without known disease in the prostate gland
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Patients with prostate cancer Healthy controls
    Started
    15
    15
    Completed
    15
    12
    Not completed
    0
    3
         We find prostate cancer on the scan
    -
    1
         hip proteses = inkonklusive images
    -
    1
         elevated PSA = eksklusion kriteria
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 18 18
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.73 ± 7.35 -
    Gender categorical
    All participants are men
    Units: Subjects
        Female
    		 0 0
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Patients with prostate cancer
    Reporting group description
    		 High risk prostate cancer patients

    Reporting group title
    Healthy controls
    Reporting group description
    		 Men without known disease in the prostate gland

    Primary: SUVmean(Tumor, PSMA guided) vs SUVmean(controls)

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    End point title
    		 SUVmean(Tumor, PSMA guided) vs SUVmean(controls)
    End point description
    End point type
    Primary
    End point timeframe
    3/2-2017 - 20/7-2017
    End point values
    		 Patients with prostate cancer Healthy controls
    Number of subjects analysed
    14 [1]
    12
    Units: SUV
    arithmetic mean (standard deviation)
        Tumor SUV mean PSMA guidet
    3.19 ± 0.48
    1.68 ± 0.37
    Notes
    [1] - One of the patients had low or none PSMA expression in the prostata.
    Statistical analysis title
    		 T-test for difference in means
    Statistical analysis description
    T-test for analysis of the difference between mean SUV in the tumors of the patients (PSMA guided) and mean SUV in the total prostate in the healthy controls.
    Comparison groups
    Patients with prostate cancer v Healthy controls
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 < 0.0001 [3]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [2] - T-test for analysis of the difference between mean SUV in the tumors of the patients (PSMA guided) and mean SUV in the total prostate in the healthy controls.
    [3] - A very low p-value that proves significantly higher mean SUV in the tumors of the patients (PSMA guided) than mean SUV in the total prostate in the healthy controls.

    Secondary: SUVmean(Tumor, 60% threshold) vs SUVmean(controls)

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    End point title
    		 SUVmean(Tumor, 60% threshold) vs SUVmean(controls)
    End point description
    End point type
    Secondary
    End point timeframe
    3/2-2017 - 30/7-2017
    End point values
    		 Patients with prostate cancer Healthy controls
    Number of subjects analysed
    15
    12
    Units: SUV
    arithmetic mean (standard deviation)
        SUV mean 60% threshold
    3.85 ± 0.82
    1.68 ± 0.37
    Statistical analysis title
    		 T-test for difference in means
    Statistical analysis description
    T-test for the difference in SUVmean in the tumors of the patients (60% threshold method) and the SUVmean of the total prostate of the healthy controls.
    Comparison groups
    Patients with prostate cancer v Healthy controls
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    P-value
    		 < 0.0001 [5]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [4] - T-test for the difference in SUVmean in the tumors of the patients (60% threshold method) and the SUVmean of the total prostate of the healthy controls.
    [5] - A very low p-value proves that SUVmean in the tumors of the patients (60% threshold method) are significantly higher than the SUVmean of the total prostate of the healthy controls.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3/2-2017 - 11/9-2017
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    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: No adverse events were reported, (this was as expected, as 82Rb has no known adverse effects)

    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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