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    Clinical Trial Results:
    A PILOT PHASE IV STUDY TO EVALUATE VARIATION IN BONE MINERAL DENSITY, LEAN AND FAT BODY MASS MEASURED BY DUAL-ENERGY X-RAY ABSORPTIOMETRY IN PATIENTS WITH PROSTATE CANCER WITHOUT BONE METASTASIS TREATED WITH DEGARELIX

    Summary
    EudraCT number
    		 2016-004210-10
    Trial protocol
    		 IT  
    Global end of trial date
    12 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Dec 2021
    First version publication date
    02 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ASSTBS-BLADE-2540-2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03202381
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 BLADE: ASSTBS-BLADE-2540-2016
    Sponsors
    Sponsor organisation name
    ASST spedalicivili di brescia
    Sponsor organisation address
    p.le spedali civili 1, brescia, Italy, 25123
    Public contact
    coordinamento ricerca, Azienda Ospedaliera Spedali Civili di Brescia, 0039 0303996851, coordinamento.ricerca@ASST-spedalicivili.it
    Scientific contact
    Alessandro Antonelli , Azienda Ospedaliera Spedali Civili di Brescia, 0039 3382503843, alessandro_antonelli@me.com
    Sponsor organisation name
    AAST SPEDALI CIVILI DI BRESCIA
    Sponsor organisation address
    P.LE SPEDALI CIVILI 1, BRESCIA, Italy, 25123
    Public contact
    ALDOMARIA ROCCARO, AAST SPEDALI CIVILI DI BRESCIA P.LE SPEDALI CIVILI 1 25123, 0039 0303996851, coordinamento.ricerca@asst-spedalicivili.it
    Scientific contact
    PROF. ALESSANDRO ANTONELLI , AAST SPEDALI CIVILI DI BRESCIA P.LE SPEDALI CIVILI 1 25123, 0039 3382503845, alessandro_antonelli@me.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
    12 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary endpoints was to assess changes in fat body mass (FBM) after 12 months of Degarelix administration. Secondary endpoints were to assess changes in lean body mass (LBM), body mass index (BMI), serum lipid profile, serum glucose profile and serum FSH
    Protection of trial subjects
    not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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
    Italy: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    8
    From 65 to 84 years
    25
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male patients willing and able to provide written informed consent. with histologically confirmed PCa without bone metastasis at bone scintigraphy, judged eligible to ADT according to current guidelines recommendations after a multisciplinary discussion were considered eligible for the study

    Pre-assignment
    Screening details
    		 screening: patients were assessed for criteria. Exclusion crit. consisted of absolute or relative contraindication to Degarelix, prior ADT treatment,prior/concomitant treatment with bisphosphonates or other drugs known to affect bone metabolism, concom. bone metabolic dis., such as Paget’s disease, primary hyperparathyroid/chronic hypercortisolism

    Pre-assignment period milestones
    Number of subjects started
    		 35
    Number of subjects completed
    		 35

    Period 1
    Period 1 title
    BASELINE
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 degarelix
    Arm description
    		 administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    degarelix
    Investigational medicinal product code
    imp 1
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression

    Number of subjects in period 1
    		degarelix
    Started
    35
    Completed
    35
    Period 2
    Period 2 title
    treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 degarelix
    Arm description
    		 administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    degarelix
    Investigational medicinal product code
    imp 1
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression

    Number of subjects in period 2
    		degarelix
    Started
    35
    Completed
    29
    Not completed
    6
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    1
         Physician decision
    2
         Lost to follow-up
    2
    Period 3
    Period 3 title
    end of tratment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 degarelix
    Arm description
    		 administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    degarelix
    Investigational medicinal product code
    imp 1
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression

    Number of subjects in period 3
    		degarelix
    Started
    29
    Completed
    29

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BASELINE
    Reporting group description
    		 -

    Reporting group values
    		 BASELINE Total
    Number of subjects
    		 35 35
    Age categorical
    adults (18-64 years) From 65-84 years 85 years and over
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 25 25
        85 years and over
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 35 35

    End points

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    End points reporting groups
    Reporting group title
    degarelix
    Reporting group description
    		 administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression
    Reporting group title
    degarelix
    Reporting group description
    		 administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression
    Reporting group title
    degarelix
    Reporting group description
    		 administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule: - Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections). - Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection). Treatment will be continued till clinically indicated or till disease progression

    Primary: To compare the mean values (adjusted for baseline T0 values) of changes in fat body mass (after 12 months of therapy, T1) as measured by DXA scan (g/cm2).

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    End point title
    		 To compare the mean values (adjusted for baseline T0 values) of changes in fat body mass (after 12 months of therapy, T1) as measured by DXA scan (g/cm2).
    End point description
    changes in fat body mass (after 12 months of therapy, T1) as measured by DXA scan
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 degarelix degarelix degarelix
    Number of subjects analysed
    35
    34
    29 [1]
    Units: g/cm2
    number (not applicable)
        na
    35
    34
    29
    Notes
    [1] - NA
    Statistical analysis title
    		 final
    Statistical analysis description
    To calculate sample size, we relied on a previous prospective cohort study, where body composition was prospectively assessed in non-metastatic PCa patients treated with LHRH agonists [16]. In order to detect an increase of FBM from 18 kg at baseline to a maximum of 21 kg at 12 months (with a SD of 4.5), with an alpha error of 0.05 and a beta error of 0.10 (which allows for 90% power), a sample size of 35 patients was estimated. This accounted for an anticipated dropout of 10%
    Comparison groups
    degarelix v degarelix
    Number of subjects included in analysis
    64
    Analysis specification
    Post-hoc
    Analysis type
    		 other [2]
    P-value
    		 < 0.05 [3]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [2] - Repeated measures paired t-test and ANOVA test tested for mean differences between bl vs. 12 m for DXA scan results and between bl vs. 6 m. vs. 12 m. for BMI and blood test parameters. Then, linear mixed models with random intercept to account for multiple measurements within each patient were used to estimate differences. Percent changes were calculated as well. P
    [3] - All statistical tests were two-sided with a level of significance set at p < 0.05. Analyses were performed using the R software environment for statistical computing and graphics (

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    unexpected serious adverse reactions, occurring from the starting time of trial (screening) treatment until 28 days post cessation of trial treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    degarelix group
    Reporting group description
    		 -

    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: the disease progression is not considered an Adverse Events
    Serious adverse events
    		 degarelix group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    General disorders and administration site conditions
    Death
    Additional description: na
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 degarelix group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)

    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.
    First, since the study power was calculated on FBM changes, many of the non-significant findings among secondary endpoints may be due to the low statistical power rather than evidence of these variables not being predictive of the clinical outcom

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33723362
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