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    Clinical Trial Results:
    Randomized double-blind placebo-controlled trial on the efficiency of a single dose dexamethasone in reducing the postembolization syndrome in men undergoing prostatic artery embolization for benign prostatic hyperplasia

    Summary
    EudraCT number
    		 2020-000915-53
    Trial protocol
    		 DK  
    Global end of trial date
    03 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2024
    First version publication date
    25 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEXAPAE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04588857
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    The Department of Radiology and The Department of Urology, Rigshospitalet, +45 35458789, andreas.roeder@regionh.dk
    Scientific contact
    The Department of Radiology and The Department of Urology, Rigshospitalet, +45 35458789, andreas.roeder@regionh.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
    03 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Reduction in post-procedural fever and pain with dexamethasone in patients undergoing prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH)
    Protection of trial subjects
    Participation in the trial was voluntary and did not affect the individual's assessment and treatment process. The participants were informed, both orally and in writing, of the study's purpose and implications. Prior to participation, the trial participants signed a consent form. Participants could withdraw their consent at any time without explanation. The standard clinical procedure was the same for trial participants.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    5
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients referred to the Department of Urology, Rigshospitaltet with lower urinary tract symptoms, and who were candidates for prostatic artery embolisation were considered for trial recruitment.

    Pre-assignment
    Screening details
    		 Inclusion criteria mimicked the standard PAE eligibility criteria at our institution. Exclusion criteria consisted of current urological contraindications to PAE, contraindications for catheter-based interventions and contraindications for high-dose steroid administration. Written informed consent was obtained from all participants prior to inclusi

    Period 1
    Period 1 title
    Intervention (Overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active Arm
    Arm description
    		 Received trial medicine dexamethasone 24 mg as a single intravenous bolus dose
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dexavit 4mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    24 mg, single dose

    Arm title
    		 Placebo arm
    Arm description
    		 Received intravenous saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium Chloride 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 ml, single dose

    Number of subjects in period 1
    		Active Arm Placebo arm
    Started
    16
    15
    Completed
    16
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention (Overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Intervention (Overall period) Total
    Number of subjects
    		 31 31
    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
        median (inter-quartile range (Q1-Q3))
    		 70 (66 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 31 31

    End points

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    End points reporting groups
    Reporting group title
    Active Arm
    Reporting group description
    		 Received trial medicine dexamethasone 24 mg as a single intravenous bolus dose

    Reporting group title
    Placebo arm
    Reporting group description
    		 Received intravenous saline

    Primary: Rectal temperature (in degrees Celsius) at 2 days following intervention

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    End point title
    		 Rectal temperature (in degrees Celsius) at 2 days following intervention
    End point description
    End point type
    Primary
    End point timeframe
    2 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Degree Celsius
        arithmetic mean (standard deviation)
    37.19 ( 0.59 )
    37.54 ( 0.7 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Pain Severity score on Brief Pain Inventory—Short Form (BPI-SF) in first 5 days following the procedure

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    End point title
    		 Pain Severity score on Brief Pain Inventory—Short Form (BPI-SF) in first 5 days following the procedure
    End point description
    End point type
    Primary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    2.94 ( 2.1 )
    1.88 ( 1.36 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Placebo arm v Active Arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Pain Interference score on Brief Pain Inventory—Short Form (BPI-SF) in first 5 days following the procedure

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    End point title
    		 Pain Interference score on Brief Pain Inventory—Short Form (BPI-SF) in first 5 days following the procedure
    End point description
    End point type
    Primary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    2.97 ( 2.2 )
    2.04 ( 1.36 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Paracetamol dose for the first 5 days

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    End point title
    		 Paracetamol dose for the first 5 days
    End point description
    End point type
    Secondary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Miligrams
        median (inter-quartile range (Q1-Q3))
    1750 (1175 to 2450)
    1600 (1000 to 2900)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Ibuprofen dose for the first 5 days

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    End point title
    		 Ibuprofen dose for the first 5 days
    End point description
    End point type
    Secondary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Miligrams
        median (inter-quartile range (Q1-Q3))
    80 (0 to 160)
    0 (0 to 306)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: C-reactive protein value at 2 days following the procedure

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    End point title
    		 C-reactive protein value at 2 days following the procedure
    End point description
    End point type
    Secondary
    End point timeframe
    Day 2 following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Miligrams per liter
        median (inter-quartile range (Q1-Q3))
    10 (5 to 33)
    108 (54 to 161)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IPSS at day 2 post procedure

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    End point title
    		 IPSS at day 2 post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    2 days post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    24.9 ( 6.9 )
    21.1 ( 6.8 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IPSS at 5 days post procedure

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    End point title
    		 IPSS at 5 days post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    Day 5 post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    23.9 ( 8.5 )
    23.3 ( 7.2 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Nausea in the first 5 days post procedure

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    End point title
    		 Nausea in the first 5 days post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Yes/no
    9
    11
    Statistical analysis title
    		 Pearsons’s Chi-squared test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Dysuria in the first 5 days post procedure

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    End point title
    		 Dysuria in the first 5 days post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Yes/no
    14
    13
    Statistical analysis title
    		 Pearsons’s Chi-squared test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Urinary tract infection in the first 5 days post procedure

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    End point title
    		 Urinary tract infection in the first 5 days post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Yes/no
    1
    0
    Statistical analysis title
    		 Pearsons’s Chi-squared test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Hospital admission in the first 5 days post procedure

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    End point title
    		 Hospital admission in the first 5 days post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Yes/no
    1
    0
    Statistical analysis title
    		 Pearsons’s Chi-squared test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Acute urinary retention in the first 5 days post procedure

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    End point title
    		 Acute urinary retention in the first 5 days post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    First 5 days following intervention
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Yes/no
    0
    2
    Statistical analysis title
    		 Pearsons’s Chi-squared test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IPSS score at 1 month post procedure

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    End point title
    		 IPSS score at 1 month post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    1 month post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    13.3 ( 9.3 )
    13.9 ( 4.9 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IPSS score at 3 months post procedure

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    End point title
    		 IPSS score at 3 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    1 month post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    11.1 ( 9.2 )
    10.9 ( 7.4 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IPSS score at 6 months post procedure

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    End point title
    		 IPSS score at 6 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    14.2 ( 8.1 )
    12.3 ( 6.2 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: International Index of Erectile Function (IIEF) score at 1 month post procedure

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    End point title
    		 International Index of Erectile Function (IIEF) score at 1 month post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    1 month post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    15.4 ( 6.3 )
    16.4 ( 6.0 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IPSS score at 3 months post procedure

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    End point title
    		 IPSS score at 3 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    3 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    16.5 ( 6.4 )
    16.6 ( 6.9 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: IPSS score at 6 months post procedure

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    End point title
    		 IPSS score at 6 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Points
        arithmetic mean (standard deviation)
    15.4 ( 7.8 )
    15.7 ( 6.9 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean urinary flow at 3 months post procedure

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    End point title
    		 Mean urinary flow at 3 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    3 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Mililiters per second
        arithmetic mean (standard deviation)
    4.8 ( 2.9 )
    4.7 ( 2.1 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean urinary flow at 6 months post procedure

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    End point title
    		 Mean urinary flow at 6 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Mililiters per second
        arithmetic mean (standard deviation)
    4.1 ( 1.7 )
    4.7 ( 2.6 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Maximum urinary flow at 3 months post procedure

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    End point title
    		 Maximum urinary flow at 3 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    3 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Mililiters per second
        arithmetic mean (standard deviation)
    12.0 ( 5.9 )
    11.9 ( 6.0 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Maximum urinary flow at 6 months post procedure

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    End point title
    		 Maximum urinary flow at 6 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Mililiters per second
        arithmetic mean (standard deviation)
    11.3 ( 5.8 )
    11.6 ( 6.6 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Prostate volume at 3 months post procedure

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    End point title
    		 Prostate volume at 3 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    3 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Cubic centimeters
        arithmetic mean (standard deviation)
    80 ( 27 )
    89 ( 33 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Prostate volume at 6 months post procedure

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    End point title
    		 Prostate volume at 6 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Cubic centimeters
        arithmetic mean (standard deviation)
    76 ( 26 )
    72 ( 18 )
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Residual urine at 3 months post procedure

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    End point title
    		 Residual urine at 3 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    3 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Mililiters
        median (inter-quartile range (Q1-Q3))
    28 (5 to 57)
    20 (0 to 57)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Residual urine at 6 months post procedure

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    End point title
    		 Residual urine at 6 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Mililiters
        median (inter-quartile range (Q1-Q3))
    49 (12 to 95)
    55 (50 to 80)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Prostate specific antigen (PSA) at 1 month post procedure

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    End point title
    		 Prostate specific antigen (PSA) at 1 month post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    1 month post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Micrograms per litre
        median (inter-quartile range (Q1-Q3))
    6.1 (5.3 to 10)
    6.4 (5.2 to 10)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Prostate specific antigen (PSA) at 3 months post procedure

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    End point title
    		 Prostate specific antigen (PSA) at 3 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    3 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Micrograms per litre
        median (inter-quartile range (Q1-Q3))
    5.3 (3.2 to 7.5)
    5.3 (3.9 to 7.3)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Prostate specific antigen (PSA) at 6 months post procedure

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    End point title
    		 Prostate specific antigen (PSA) at 6 months post procedure
    End point description
    End point type
    Secondary
    End point timeframe
    6 months post procedure
    End point values
    		 Active Arm Placebo arm
    Number of subjects analysed
    16
    15
    Units: Micrograms per litre
        median (inter-quartile range (Q1-Q3))
    5.1 (3.9 to 8.8)
    5.4 (4.5 to 7.9)
    Statistical analysis title
    		 Independent t-test
    Comparison groups
    Active Arm v Placebo arm
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 6 months post intervention
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Frequency threshold for reporting non-serious adverse events: 1%
    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 serious adverse events (SAEs) have been observed or reported. and no non-serious adverse events (AEs) were recorded. The absence of non-serious AEs aligns with the study findings, as no participants reported any conditions meeting the criteria for classification as non-serious adverse events. The study was closely monitored to ensure compliance with regulatory guidelines.

    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/38233575
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