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    Clinical Trial Results:
    Randomized Assessment of patients with clinically suspected Prostate cancer after multiparametric metabolic hybrid Imaging to evaluate its potential clinical Domain: A prospective, randomized, multi-arm, multi-treatment clinical trial

    Summary
    EudraCT number
    		 2014-004758-33
    Trial protocol
    		 AT  
    Global end of trial date
    01 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Apr 2026
    First version publication date
    08 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Rapid-study
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Prof. Marcus Hacker, Medical University of Vienna, marcus.hacker@meduniwien.ac.at
    Scientific contact
    Prof. Marcus Hacker, Medical University of Vienna, marcus.hacker@meduniwien.ac.at
    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
    12 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We hypothesize that the image guided biopsy using multiparametric metabolic hybrid imaging with [18F]Fluoroethylcholine (FEC)/[68]Ga-PSMA-PET/MRI is superior in the detection of primary localized prostate cancer than the conventional biopsy approach with transrectal ultrasound in patients with suspected prostate cancer (according to the inclusion criteria) and could therefore significantly improve the detection rate of the dominant intraprostatic tumor lesion and reduce the number of biopsies needed for a correct histopathological diagnosis to a minimum in the future (PET/MRI guided biopsy).
    Protection of trial subjects
    In this prospective randomized clinical trial including 220 men clinically suspicious of having prostate cancer, PSMA-targeted PET/MRI identified 91/113 histologically confirmed prostate cancers, 57/60 ISUP grade >2 tumors and predicted unfavorable disease in 23/25 patients in a median 3 years follow-up. 4-core PET/MRI-guided biopsy showed a comparable diagnostic efficacy as more invasive standard random biopsy. The results support the integration of this reliable imaging technique into clinical practice to improve the non-invasive diagnosis and prognostic categorization of prostate cancer, potentially reducing unnecessary biopsies and overtreatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 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
    Austria: 220
    Worldwide total number of subjects
    220
    EEA total number of subjects
    220
    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)
    149
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants were men with clinical signs suggestive of PCa, including elevated (.4.0 ng/mL) and progressively rising blood prostate-specific antigen (PSA) levels despite antibiotic treatment, or a free-to-total PSA ratio of less than 22%.

    Pre-assignment
    Screening details
    		 Eligible participants were men with clinical signs suggestive of PCa, including elevated (.4.0 ng/mL) and progressively rising blood prostate-specific antigen (PSA) levels despite antibiotic treatment, or a free-to-total PSA ratio of less than 22%.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 random biopsy Arm
    Arm description
    		 The study randomly assigned patients (target of 220) to either the standard (random biopsy [RB]) group with a 12-core or greater standardized random needle biopsy (masked to PET/MRI results), or the image-guided biopsy (IGB) group, which involved the standardized 12-core needle biopsy plus 4 computer-assisted PET/MRI-guided targeted biopsies. An electronically generated randomization list was used to assign patients to each group after inclusion and exclusion criteria were checked for suitability by the principal investigator. All patients were to undergo multiparametric endorectal [18F]fluoroethylcholine PSMA PET/MRI. Within 1 mo of imaging and randomization, patients were scheduled for RB or IGB, followed by an end-of-study visit within 2 wk or by surgery with an end-of-study visit. Follow-up visits were planned at 6, 12, 18, and 24 mo after the end-of-study visit. Further reporting on follow-up was performed voluntarily until the study closed on June 15, 2023.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    18F fluoroethylcholine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    3MBq/kg Bodyweight

    Investigational medicinal product name
    68Ga PSMA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    2MBq/kg Bodyweight

    Arm title
    		 Image guided biopsy arm
    Arm description
    		 The study randomly assigned patients (target of 220) to either the standard (random biopsy [RB]) group with a 12-core or greater standardized random needle biopsy (masked to PET/MRI results), or the image-guided biopsy (IGB) group, which involved the standardized 12-core needle biopsy plus 4 computer-assisted PET/MRI-guided targeted biopsies. An electronically generated randomization list was used to assign patients to each group after inclusion and exclusion criteria were checked for suitability by the principal investigator. All patients were to undergo multiparametric endorectal [18F]fluoroethylcholine PSMA PET/MRI. Within 1 mo of imaging and randomization, patients were scheduled for RB or IGB, followed by an end-of-study visit within 2 wk or by surgery with an end-of-study visit. Follow-up visits were planned at 6, 12, 18, and 24 mo after the end-of-study visit. Further reporting on follow-up was performed voluntarily until the study closed on June 15, 2023.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    18F fluoroethylcholine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    3MBq/kg Bodyweight

    Investigational medicinal product name
    68Ga PSMA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    2MBq/kg Bodyweight

    Number of subjects in period 1
    		random biopsy Arm Image guided biopsy arm
    Started
    110
    110
    Completed
    106
    104
    Not completed
    4
    6
         Consent withdrawn by subject
    -
    1
         contrainducation for MRI
    1
    -
         Biopsy refused
    2
    3
         PSA control less than 4 ng/mL
    -
    1
         Lost to follow-up
    1
    -
         secondary cancer
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    random biopsy Arm
    Reporting group description
    		 The study randomly assigned patients (target of 220) to either the standard (random biopsy [RB]) group with a 12-core or greater standardized random needle biopsy (masked to PET/MRI results), or the image-guided biopsy (IGB) group, which involved the standardized 12-core needle biopsy plus 4 computer-assisted PET/MRI-guided targeted biopsies. An electronically generated randomization list was used to assign patients to each group after inclusion and exclusion criteria were checked for suitability by the principal investigator. All patients were to undergo multiparametric endorectal [18F]fluoroethylcholine PSMA PET/MRI. Within 1 mo of imaging and randomization, patients were scheduled for RB or IGB, followed by an end-of-study visit within 2 wk or by surgery with an end-of-study visit. Follow-up visits were planned at 6, 12, 18, and 24 mo after the end-of-study visit. Further reporting on follow-up was performed voluntarily until the study closed on June 15, 2023.

    Reporting group title
    Image guided biopsy arm
    Reporting group description
    		 The study randomly assigned patients (target of 220) to either the standard (random biopsy [RB]) group with a 12-core or greater standardized random needle biopsy (masked to PET/MRI results), or the image-guided biopsy (IGB) group, which involved the standardized 12-core needle biopsy plus 4 computer-assisted PET/MRI-guided targeted biopsies. An electronically generated randomization list was used to assign patients to each group after inclusion and exclusion criteria were checked for suitability by the principal investigator. All patients were to undergo multiparametric endorectal [18F]fluoroethylcholine PSMA PET/MRI. Within 1 mo of imaging and randomization, patients were scheduled for RB or IGB, followed by an end-of-study visit within 2 wk or by surgery with an end-of-study visit. Follow-up visits were planned at 6, 12, 18, and 24 mo after the end-of-study visit. Further reporting on follow-up was performed voluntarily until the study closed on June 15, 2023.

    Reporting group values
    		 random biopsy Arm Image guided biopsy arm Total
    Number of subjects
    		 110 110 220
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 79 70 149
        From 65-84 years
    		 31 40 71
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 110 110 220

    End points

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    End points reporting groups
    Reporting group title
    random biopsy Arm
    Reporting group description
    		 The study randomly assigned patients (target of 220) to either the standard (random biopsy [RB]) group with a 12-core or greater standardized random needle biopsy (masked to PET/MRI results), or the image-guided biopsy (IGB) group, which involved the standardized 12-core needle biopsy plus 4 computer-assisted PET/MRI-guided targeted biopsies. An electronically generated randomization list was used to assign patients to each group after inclusion and exclusion criteria were checked for suitability by the principal investigator. All patients were to undergo multiparametric endorectal [18F]fluoroethylcholine PSMA PET/MRI. Within 1 mo of imaging and randomization, patients were scheduled for RB or IGB, followed by an end-of-study visit within 2 wk or by surgery with an end-of-study visit. Follow-up visits were planned at 6, 12, 18, and 24 mo after the end-of-study visit. Further reporting on follow-up was performed voluntarily until the study closed on June 15, 2023.

    Reporting group title
    Image guided biopsy arm
    Reporting group description
    		 The study randomly assigned patients (target of 220) to either the standard (random biopsy [RB]) group with a 12-core or greater standardized random needle biopsy (masked to PET/MRI results), or the image-guided biopsy (IGB) group, which involved the standardized 12-core needle biopsy plus 4 computer-assisted PET/MRI-guided targeted biopsies. An electronically generated randomization list was used to assign patients to each group after inclusion and exclusion criteria were checked for suitability by the principal investigator. All patients were to undergo multiparametric endorectal [18F]fluoroethylcholine PSMA PET/MRI. Within 1 mo of imaging and randomization, patients were scheduled for RB or IGB, followed by an end-of-study visit within 2 wk or by surgery with an end-of-study visit. Follow-up visits were planned at 6, 12, 18, and 24 mo after the end-of-study visit. Further reporting on follow-up was performed voluntarily until the study closed on June 15, 2023.

    Primary: Superior cancer detaction

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    End point title
    		 Superior cancer detaction
    End point description
    To demonstrate that multiparametric metabolic hybrid imaging with FEC/ PSMA-PET/MRI is superior in the detection of primary localized prostate cancer than the conventional biopsy approach (TRUS-guided) in patients with suspected prostate cancer (according to the inclusion criteria) and to significantly improve the detection rate of the dominant intraprostatic tumor lesion and reduce the number of biopsies needed for a correct histopathological diagnosis to a minimum in the future (PET/MRI guided biopsy).
    End point type
    Primary
    End point timeframe
    Between February 5, 2016, and February 4, 2020
    End point values
    		 random biopsy Arm Image guided biopsy arm
    Number of subjects analysed
    110
    110
    Units: percent
    31
    29
    Statistical analysis title
    		 Analysis primary endpoint
    Comparison groups
    random biopsy Arm v Image guided biopsy arm
    Number of subjects included in analysis
    220
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared corrected
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Between February 5, 2016, and February 4, 2020
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: There was no adverse events

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/41266255
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