Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

    Summary
    EudraCT number
    		 2020-000121-37
    Trial protocol
    		 FR   BE   NL  
    Global end of trial date
    12 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Oct 2023
    First version publication date
    06 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2020-PSMA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04734184
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CURIUM PET France
    Sponsor organisation address
    3 rue Marie Curie, Saint Beauzire, France, 63360
    Public contact
    Aurélie ETRINGER, ICTA PM, 33 380534039, aurelie.etringer@icta.fr
    Scientific contact
    Aurélie ETRINGER, ICTA PM, 33 380534039, aurelie.etringer@icta.fr
    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
    02 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT
    Protection of trial subjects
    No specific measures put in place
    Background therapy
    		 None
    Evidence for comparator
    		 18F-fluorocholine is a PET tracer marketed in Europe
    Actual start date of recruitment
    05 May 2020
    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
    Netherlands: 9
    Country: Number of subjects enrolled
    Spain: 70
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    France: 135
    Worldwide total number of subjects
    217
    EEA total number of subjects
    217
    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)
    40
    From 65 to 84 years
    175
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients with prostate cancer presenting a biochemical recurrence after curative initial therapy

    Pre-assignment
    Screening details
    		 •Male •Age≥18 years •Histopathological proven prostate adenocarcinoma per original diagnosis •First suspected recurrence of PCa based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy ,of PSA ≥ 0.2 ng/mL confirmed by a subsequent PSA level of ≥0.2 ng/mL, or in case of radiation therapy (external

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 18F-DCFPyl followed by 18F-Fluorocholine
    Arm description
    		 Each patient receives 18F-DCFPyL followed by 18F-Fluorocholine within 12 days
    Arm type
    		 cross-over

    Investigational medicinal product name
    18FDCFPyL
    Investigational medicinal product code
    Other name
    PYLCLARI
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    330 MBq

    Investigational medicinal product name
    18F-fluorocholine
    Investigational medicinal product code
    Other name
    PROSTATEP
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    2 - 4 MBq/kg

    Arm title
    		 18F-fluorocholine followed by 18F-DCFPyL
    Arm description
    		 each patient receives 18F-fluorocholine followed by 18F-DCFPyL within 12 days
    Arm type
    		 cross-over

    Investigational medicinal product name
    18F-fluorocholine
    Investigational medicinal product code
    Other name
    PROSTATEP
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2-4 MBq/kg

    Investigational medicinal product name
    18F-DCFPyL
    Investigational medicinal product code
    Other name
    PYLCLARI
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    330 MBq

    Number of subjects in period 1
    		18F-DCFPyl followed by 18F-Fluorocholine 18F-fluorocholine followed by 18F-DCFPyL
    Started
    108
    109
    Completed
    108
    107
    Not completed
    0
    2
         Physician decision
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    18F-DCFPyl followed by 18F-Fluorocholine
    Reporting group description
    		 Each patient receives 18F-DCFPyL followed by 18F-Fluorocholine within 12 days

    Reporting group title
    18F-fluorocholine followed by 18F-DCFPyL
    Reporting group description
    		 each patient receives 18F-fluorocholine followed by 18F-DCFPyL within 12 days

    Reporting group values
    		 18F-DCFPyl followed by 18F-Fluorocholine 18F-fluorocholine followed by 18F-DCFPyL Total
    Number of subjects
    		 108 109 217
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 20 40
        From 65-84 years
    		 87 88 175
        85 years and over
    		 1 1 2
    Age continuous
    70.0
    Units: years
        arithmetic mean (standard deviation)
    		 70.0 ± 7.1 70.0 ± 7.1 -
    Gender categorical
    Male only
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 108 109 217
    initial curative treatment
    Patients have initially been treated by surgery or radiotherapy
    Units: Subjects
        surgery
    		 81 77 158
        radiotherapy
    		 27 32 59
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who have received at least one injection

    Subject analysis set title
    18F-DCFPyL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who received 18F-DCFPyL

    Subject analysis set title
    18F-Fluorocholine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who received 18F-fluorocholine

    Subject analysis sets values
    		 Full analysis set 18F-DCFPyL 18F-Fluorocholine
    Number of subjects
    205
    205
    205
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    40
        From 65-84 years
    163
        85 years and over
    2
    Age continuous
    70.0
    Units: years
        arithmetic mean (standard deviation)
    70.0 ± 7.1
    70.0 ± 7.1
    70.0 ± 7.1
    Gender categorical
    Male only
    Units: Subjects
        Female
    0
        Male
    205
    initial curative treatment
    Patients have initially been treated by surgery or radiotherapy
    Units: Subjects
        surgery
    150
        radiotherapy
    55

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    18F-DCFPyl followed by 18F-Fluorocholine
    Reporting group description
    		 Each patient receives 18F-DCFPyL followed by 18F-Fluorocholine within 12 days

    Reporting group title
    18F-fluorocholine followed by 18F-DCFPyL
    Reporting group description
    		 each patient receives 18F-fluorocholine followed by 18F-DCFPyL within 12 days

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who have received at least one injection

    Subject analysis set title
    18F-DCFPyL
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who received 18F-DCFPyL

    Subject analysis set title
    18F-Fluorocholine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients who received 18F-fluorocholine

    Primary: Per-patient detection rate

    		 Close Top of page
    End point title
    		 Per-patient detection rate
    End point description
    Images were read by 3 independent " blinded " readers. Per-patient detection rate was computed for each reader independently
    End point type
    Primary
    End point timeframe
    Overall study
    End point values
    		 18F-DCFPyL 18F-Fluorocholine
    Number of subjects analysed
    205
    205
    Units: percent
    58
    40
    Statistical analysis title
    		 prescott's test
    Statistical analysis description
    The Prescott’s test was used to assess the difference between the two methods in term of detection. On the FAS, only “observed cases” were taken into account (i.e., no imputation was performed, and was considered as “assessed” in all patients with at least an evaluation by one of the independent readers) . The per-patient detection rate was computed for each reader independently .
    Comparison groups
    18F-DCFPyL v 18F-Fluorocholine
    Number of subjects included in analysis
    410
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Prescott's test
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.7
         upper limit
    		 -

    Secondary: per-region detection rate

    		 Close Top of page
    End point title
    		 per-region detection rate
    End point description
    Per-region detection rates will be analysed in the FAS in the same way as the per-patient detection rates. The per-region detection rate will be defined as follows: number of patients defined as positive for a given region by the independent readers / total number of pateints assessde for a given region
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 18F-DCFPyL 18F-Fluorocholine
    Number of subjects analysed
    201
    201
    Units: percent
        prostate bed
    21
    11
        pelvic lymph nodes
    29
    25
        extra-pelvic lymph nodes
    8
    14
        bones
    17
    9
        other organs
    9
    2
    No statistical analyses for this end point

    Secondary: sensitivity

    		 Close Top of page
    End point title
    		 sensitivity
    End point description
    Number of true positive cases / True positive + false negative
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 18F-DCFPyL 18F-Fluorocholine
    Number of subjects analysed
    205
    205
    Units: percent
    58
    41
    Statistical analysis title
    		 Chi squared
    Comparison groups
    18F-DCFPyL v 18F-Fluorocholine
    Number of subjects included in analysis
    410
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.001
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Any AE starting at the time or within the 24 hours following the start of injection (of 18F-DCFPyL or 18F-FCH) up to 48 h after injection.
    Adverse event reporting additional description
    An event was considered as related to the study treatment if the relationship is ticked “Possible”, “Probable” or “Definite”.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    full analysis set
    Reporting group description
    		 all patients having received at least one injection

    Serious adverse events
    		 full analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 205 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 full analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 205 (2.93%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Nervous system disorders
    headache
         subjects affected / exposed
    2 / 205 (0.98%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Limb discomfort
         subjects affected / exposed
    1 / 205 (0.49%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 01 00:46:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA