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    Clinical Trial Results:
    Etude monocentrique, exploratoire, comparant la TEP/TDM au 68Ga-RM2 à la TEP/TDM au 68Ga-PSMA-617 chez des patients atteints de cancers de la prostate de différents risques métastatiques, candidats à une prostatectomie totale

    Summary
    EudraCT number
    		 2017-000490-36
    Trial protocol
    		 FR  
    Global end of trial date
    11 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2026
    First version publication date
    18 Sep 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUBX2016/38
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03604757
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Bordeaux
    Sponsor organisation address
    12 Rue Dubernat, Talence, France, 33404
    Public contact
    Dr Henri de CLERMONT-GALLERANDE, Service de Médecine Nucléaire, +33 0556795540, henri.de-clermont-galleran@chu-bordeaux.fr
    Scientific contact
    Dr Henri de CLERMONT-GALLERANDE, Service de Médecine Nucléaire, +33 0556795540, henri.de-clermont-galleran@chu-bordeaux.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
    27 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To compare 68Ga-PSMA-617 uptakes values between prostatic sextants for which histologic examination reveal a Gleason score 6, those for which histologic examination reveal a Gleason score 7(3+4) (favourable intermediate risk), for which histologic examination reveal a Gleason score 7(4+3) (unfavourable intermediate risk) and those for which histologic examination reveal a Gleason score 8 or more - To compare 68Ga-RM2 uptakes values between prostatic sextants for which histologic examination reveal a Gleason score 6, those for which histologic examination reveal a Gleason score 3+4 (favourable intermediate risk), those for which histologic examination reveal a Gleason score 4+3 (unfavourable intermediate risk) and for which histologic examination reveal a Gleason score 8 or more
    Protection of trial subjects
    There was no specific protection measure put in place in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2018
    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
    France: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 the recruitment phase started on April 25th 2018 and ended on April 25the 2020. Patients were included in one centre, the Bordeaux University Hospital.

    Pre-assignment
    Screening details
    		 The study included patients with newly diagnosed, biopsy-proven, prostate cancer Other inclusion criteria were age greater than 18y, and indication for prostatectomy. No patient had received neoadjuvant hormone therapy or chemotherapy. All patients underwent extended pelvic lymph node dissection.

    Period 1
    Period 1 title
    Overall study (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
    		 68Ga-PSMA-617 PET/CT
    Arm description
    		 68Ga-PSMA-617 PET/CT
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]Ga-PSMA-617
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Radiopharmaceutical precursor, solution
    Routes of administration
    Injection
    Dosage and administration details
    Using an automated synthesizer (GE FastLab, GE Healthcare, GEMS Benelux, Belgium), the 68Ge/68Ga generator (GalliAd®, IRE ELIT, Belgium, nominal activity 1850MBq at calibration date) was eluted with a sterile solution of hydrochoric acid (HCl) 0.1M in the reactor vial containing PSMA-617 (10 µg, GMP grade, ABX GmBH) or RM2 (40µg, GMP grade, Life Molecular Imaging). In the case of RM2, 5mg of ascorbic acid were also added to prevent radiolysis. The reaction solution was heated at 90°C for 5 min using microwaves. The raw solution was then purified on a C18 cartridge (WAT023501) preconditioned with 1mL ethanol (Merck®) and 5 mL water (GE®). The final product was then formulated in sterile phosphate buffer saline and NaCl 0.9%, and filtered with a 0.22 µm filter.

    Arm title
    		 68Ga-RM2 PET/CT
    Arm description
    		 68Ga-RM2 PET/CT
    Arm type
    		 Active comparator

    Investigational medicinal product name
    68Ga-RM2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Radiopharmaceutical precursor, solution
    Routes of administration
    Injection
    Dosage and administration details
    Using an automated synthesizer (GE FastLab, GE Healthcare, GEMS Benelux, Belgium), the 68Ge/68Ga generator (GalliAd®, IRE ELIT, Belgium, nominal activity 1850MBq at calibration date) was eluted with a sterile solution of hydrochoric acid (HCl) 0.1M in the reactor vial containing PSMA-617 (10 µg, GMP grade, ABX GmBH) or RM2 (40µg, GMP grade, Life Molecular Imaging). In the case of RM2, 5mg of ascorbic acid were also added to prevent radiolysis. The reaction solution was heated at 90°C for 5 min using microwaves. The raw solution was then purified on a C18 cartridge (WAT023501) preconditioned with 1mL ethanol (Merck®) and 5 mL water (GE®). The final product was then formulated in sterile phosphate buffer saline and NaCl 0.9%, and filtered with a 0.22 µm filter.

    Number of subjects in period 1
    		68Ga-PSMA-617 PET/CT 68Ga-RM2 PET/CT
    Started
    11
    11
    Completed
    11
    11

    Baseline characteristics

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

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64 ( 5.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 22 22
    Gleason score
    Units: Subjects
        <6
    		 5 5
        7 (3+4)
    		 6 6
        7 (4+3)
    		 4 4
        8 (4+4, 3+5, 5+3)
    		 2 2
        >8
    		 5 5
    TNM (T)
    Units: Subjects
        T2a
    		 19 19
        T2c
    		 3 3
    Body Mass Index
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 27.4 ( 3.8 ) -
    Prostate Specific Antigen (PSA)
    Units: ng/mL
        arithmetic mean (standard deviation)
    		 8.3 ( 4 ) -

    End points

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    End points reporting groups
    Reporting group title
    68Ga-PSMA-617 PET/CT
    Reporting group description
    		 68Ga-PSMA-617 PET/CT

    Reporting group title
    68Ga-RM2 PET/CT
    Reporting group description
    		 68Ga-RM2 PET/CT

    Primary: Maximum Standardized Uptake Value (SUV max) using 68Ga-PSMA-617 PET/CT or 68Ga-RM2 PET/CT

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    End point title
    		 Maximum Standardized Uptake Value (SUV max) using 68Ga-PSMA-617 PET/CT or 68Ga-RM2 PET/CT
    End point description
    End point type
    Primary
    End point timeframe
    This is a diagnostic study where the primary endpoint is measured only once
    End point values
    		 68Ga-PSMA-617 PET/CT 68Ga-RM2 PET/CT
    Number of subjects analysed
    11
    11
    Units: Standard Unit Value
    arithmetic mean (standard deviation)
        Gleason 6 (3+3)
    3.26 ( 1 )
    3.56 ( 1.3 )
        Gleason 7 (3+4)
    3.79 ( 0.97 )
    6.36 ( 2.4 )
        Gleason 7 (4+3)
    6.33 ( 1.08 )
    7.3 ( 3.12 )
        Gleason 8, 9 or 10
    8.81 ( 5.27 )
    6.58 ( 3.06 )
    Statistical analysis title
    		 comparisons of Ga-PSMA-617 SUV between ISUP scores
    Comparison groups
    68Ga-PSMA-617 PET/CT v 68Ga-RM2 PET/CT
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0025
    Method
    		 Mixed models analysis
    Parameter type
    		 percentage of variation
    Confidence interval
    Notes
    [1] - Comparisons of SUVmax were performed at the cancer nodule level. All comparisons of SUVmax between ISUP scores used univariable mixed linear regression models including a random intercept to consider the intra-patient correlation (with a variance components structure). Model’s hypotheses (normality and heteroscedasticity of residuals) were systematically checked and led us to transform SUVmax values in pathologic tissues by the natural logarithm.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    UROPET was a transversal study. Only one day of participation for each patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Whole study group
    Reporting group description
    		 -

    Serious adverse events
    		 Whole study group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.01%
    Non-serious adverse events
    		 Whole study group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    Vascular disorders
    Epistaxis
         subjects affected / exposed
    1 / 22 (4.55%)
         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
    08 Oct 2019
    Extension of inclusion period for 6 months

    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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