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    Clinical Trial Results:
    A phase 3, open-label study to assess the clinical utility of fluciclovine (18F) PET/CT in patients with prostate cancer with biochemical recurrence after radical treatment

    Summary
    EudraCT number
    		 2015-000625-37
    Trial protocol
    		 GB  
    Global end of trial date
    25 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2019
    First version publication date
    08 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BED-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02578940
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Blue Earth Diagnostics Limited
    Sponsor organisation address
    Oxford Science Park, Magdalen Centre, Robert Robinson Avenue, Oxford, United Kingdom, OX4 4GA
    Public contact
    Blue Earth Diagnostics Limited, Blue Earth Diagnostics Limited, 44 1865784186, contact@blueearthDx.com
    Scientific contact
    Blue Earth Diagnostics Limited, Blue Earth Diagnostics Limited, 44 1865784186, contact@blueearthDx.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
    25 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the clinical impact of fluciclovine (18F) PET/CT in affecting management decisions in patients with biochemical recurrence of prostate cancer (BCR) being considered for radical salvage treatment (with curative intent).
    Protection of trial subjects
    Safety Monitoring Committee
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 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
    United Kingdom: 109
    Worldwide total number of subjects
    109
    EEA total number of subjects
    109
    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)
    31
    From 65 to 84 years
    77
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted between 27 November 2015 (first patient, screening visit) and 22 June 2018 (last patient, completed) at seven sites (one did not enrol) in the UK.

    Pre-assignment
    Screening details
    		 104 (95.4%) patients received 18F-fluciclovine injection, 103 (94.5%) patients completed the study and 6 (5.5%) patients prematurely discontinued the study. The most frequent reason for withdrawal was screening failure (5 [4.6%] patients). In addition, 1 (0.9%) patient had ‘other’ listed as their reason for study discontinuation.

    Pre-assignment period milestones
    Number of subjects started
    		 109
    Number of subjects completed
    		 104

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen Failure: 5
    Period 1
    Period 1 title
    Received 18F-fluciclovine (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 18F-Fluciclovine
    Arm description
    		 Single intravenous administration of 18F-Fluciclovine for PET Scan 18F-Fluciclovine PET CT: Radioligand for PET CT scanning
    Arm type
    		 Experimental

    Investigational medicinal product name
    18F-Fluciclovine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Radioligand for PET CT scanning

    Number of subjects in period 1 [1]
    		18F-Fluciclovine
    Started
    104
    Completed
    103
    Not completed
    1
         Lost to follow-up
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 109 Consented and 104 received study drug, 103 completed

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18F-Fluciclovine
    Reporting group description
    		 Single intravenous administration of 18F-Fluciclovine for PET Scan 18F-Fluciclovine PET CT: Radioligand for PET CT scanning

    Reporting group values
    		 18F-Fluciclovine Total
    Number of subjects
    		 104 104
    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)
    		 31 31
        From 65-84 years
    		 73 73
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 67 (49 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 104 104
    Ethnicity (NIH/OMB)
    Units: Subjects
        Not Hispanic or Latino
    		 104 104
    Region of Enrollment
    Units: Subjects
        United Kingdom
    		 104 104
    Height
    Units: cm
        median (full range (min-max))
    		 176.0 (157 to 197) -
    Weight
    Units: Kg
        median (full range (min-max))
    		 82.80 (56.0 to 134.0) -
    Body Mass Index
    Units: kg/m2
        median (full range (min-max))
    		 26.50 (19.6 to 42.3) -

    End points

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    End points reporting groups
    Reporting group title
    18F-Fluciclovine
    Reporting group description
    		 Single intravenous administration of 18F-Fluciclovine for PET Scan 18F-Fluciclovine PET CT: Radioligand for PET CT scanning

    Subject analysis set title
    Overall Evaluable Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall Evaluable Analysis Set

    Subject analysis set title
    Positive 18F-fluciclovine Scan
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with a Positive 18F-fluciclovine Scan

    Subject analysis set title
    Negative 18F-fluciclovine Scan
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with a Negative 18F-fluciclovine Scan

    Subject analysis set title
    Salvage therapy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Proportion of patients who had to radical salvage therapy

    Subject analysis set title
    Salvage therapy guided by 18F-fluciclovine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Salvage therapy guided by 18F-fluciclovine

    Subject analysis set title
    Salvage therapy not guided by 18F-fluciclovine
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Salvage therapy not guided by 18F-fluciclovine

    Subject analysis set title
    PSA Subgroup 0 to 0.2 (ng/mL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PSA Subgroup 0 to 0.2 (ng/mL)

    Subject analysis set title
    PSA Subgroup >0.2 to 0.5 (ng/mL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PSA Subgroup >0.2 to 0.5 (ng/mL)

    Subject analysis set title
    PSA Subgroup >0.5 to 1.0 (ng/mL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PSA Subgroup >0.5 to 1.0 (ng/mL)

    Subject analysis set title
    PSA Subgroup >1.0 to 2.0 (ng/mL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PSA Subgroup >1.0 to 2.0 (ng/mL)

    Subject analysis set title
    PSA Subgroup >2.0 to 5.0 (ng/mL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PSA Subgroup >2.0 to 5.0 (ng/mL)

    Subject analysis set title
    PSA Subgroup >5.0 to 10.0 (ng/mL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PSA Subgroup >5.0 to 10.0 (ng/mL)

    Subject analysis set title
    PSA Subgroup >10 (ng/mL)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PSA Subgroup >10 (ng/mL)

    Primary: Impact on Patient Treatment /Management

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    End point title
    		 Impact on Patient Treatment /Management [1]
    End point description
    The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan - descriptive statistics only.
    End point type
    Primary
    End point timeframe
    1 month
    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: Descriptive analysis only
    End point values
    		 Overall Evaluable Analysis Set Positive 18F-fluciclovine Scan Negative 18F-fluciclovine Scan
    Number of subjects analysed
    104
    58
    46
    Units: Participants
        Patients with Revised Management Plan
    66
    53
    13
        No Revision to Management Plan
    38
    5
    33
    No statistical analyses for this end point

    Secondary: Response Rate to Radical Salvage Therapy

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    End point title
    		 Response Rate to Radical Salvage Therapy
    End point description
    To establish the proportion of patients who have a sustained response to radical salvage therapy - Descriptive analysis only
    End point type
    Secondary
    End point timeframe
    7 months
    End point values
    		 Salvage therapy Salvage therapy guided by 18F-fluciclovine Salvage therapy not guided by 18F-fluciclovine
    Number of subjects analysed
    56
    17
    39
    Units: Participants
        Treatment response
    43
    15
    28
        Stable disease
    5
    0
    5
        Disease progression
    8
    2
    6
    No statistical analyses for this end point

    Secondary: PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR

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    End point title
    		 PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
    End point description
    PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT - Descriptive analysis only
    End point type
    Secondary
    End point timeframe
    1 month
    End point values
    		 PSA Subgroup 0 to 0.2 (ng/mL) PSA Subgroup >0.2 to 0.5 (ng/mL) PSA Subgroup >0.5 to 1.0 (ng/mL) PSA Subgroup >1.0 to 2.0 (ng/mL) PSA Subgroup >2.0 to 5.0 (ng/mL) PSA Subgroup >5.0 to 10.0 (ng/mL) PSA Subgroup >10 (ng/mL)
    Number of subjects analysed
    18
    27
    11
    5
    24
    11
    8
    Units: Percentage of Detection Rate
        number (confidence interval 95%)
    33.3 (13.3 to 59.0)
    25.9 (11.1 to 46.3)
    36.4 (10.9 to 69.2)
    20 (0.5 to 71.6)
    91.7 (73.0 to 99.0)
    90.9 (58.7 to 99.8)
    100 (63.1 to 100)
    No statistical analyses for this end point

    Secondary: Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.

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    End point title
    		 Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
    End point description
    Safety was assessed from data on the occurrence of adverse events (AEs) and changes in clinical laboratory tests, vital signs, injection-site status and physical examination findings from the time of administration of 18F fluciclovine injection throughout the study period - Descriptive analysis only.
    End point type
    Secondary
    End point timeframe
    1 Month
    End point values
    		 18F-Fluciclovine
    Number of subjects analysed
    27
    Units: Participants
        TEAEs Unrelated
    18
        TEAEs Possibly
    8
        TEAEs Probably
    0
        TEAEs Definitely
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    As specified in the Statistical Analysis Plan, results are presented as only those treatment-emergent adverse events which occurred up to 42 days after the 18F fluciclovine administration
    Adverse event reporting additional description
    3 additional pre-treatment (None Treatment treatment-emergent) Adverse Events also reported during the study are not listed below.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    18F-Fluciclovine PET CT
    Reporting group description
    		 Single intravenous administration of 18F-Fluciclovine for PET Scan 18F-Fluciclovine PET CT: Radioligand for PET CT scanning

    Serious adverse events
    		 18F-Fluciclovine PET CT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 104 (0.96%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Renal and urinary disorders
    Urinary tract obstruction
    Additional description: One serious TEAE was reported for one (1.0%) patient. This Grade 1 event of urinary tract obstruction occurred on Day 2 of the study, but was judged as unrelated to 18F-fluciclovine administration.
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 18F-Fluciclovine PET CT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 104 (25.96%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 104 (2.88%)
         occurrences all number
    3
    Biopsy prostate
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanoma recurrent
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Post procedural contusion
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 104 (3.85%)
         occurrences all number
    4
    Dizziness
         subjects affected / exposed
    2 / 104 (1.92%)
         occurrences all number
    2
    Dysgeusia
         subjects affected / exposed
    2 / 104 (1.92%)
         occurrences all number
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Parosmia
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site reaction
         subjects affected / exposed
    3 / 104 (2.88%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    3 / 104 (2.88%)
         occurrences all number
    3
    Application site erythema
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Catheter site bruise
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Injection site erythema
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary mass
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Neck mass
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 104 (0.96%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2015
    Changes include: • Principal Investigator list updated • Planned study period was corrected in the synopsis • Clarification on patients undergoing scan in the presence of an abnormal urinalysis. • Schedule of Assessments updated • Timings of follow-up telephone consultations updated
    05 Apr 2016
    Changes Include: • Updates to the site and Principal Investigator list. • Inclusion of a description of the site specific sub study. • Duration of 18F-fluciclovine injection was reduced. • Timing of the first blood pressure measurement post-injection and Vital signs measurements adjusted. • Timing of the post-scan telephone call to the patient to report AEs post-injection was increased
    02 Mar 2017
    Changes include: • Reporting of how suspected non-prostate cancer related cancer findings clarified. • Change of medical monitor. • Inclusion of reference to the SAP.
    04 Jun 2018
    Changes include: • Removal of two secondary endpoints:

    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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