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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    Phase II Single-arm Study evaluating Neo-adjuvant (pre-radical radiotherapy) Abiraterone acetate (plus prednisolone) and Gonadotropin-Releasing Hormone (GnRH) agonist in high risk localised prostate carcinoma

    Summary
    EudraCT number
    		 2014-001128-31
    Trial protocol
    		 IE  
    Global end of trial date
    19 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    13-23
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02160353
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cancer Trials Ireland
    Sponsor organisation address
    Ardilaun House, Dublin, Ireland, D02 VN51
    Public contact
    Head of Clinical Operations, Cancer Trials Ireland, +353 16677211, info@cancertrials.ie
    Scientific contact
    Head of Clinical Operations, Cancer Trials Ireland, +353 16677211, info@cancertrials.ie
    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
    25 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: To evaluate the clinical tumour and biochemical response, and mean percentage reduction in prostate gland volume; achieved by 126 days of neo-adjuvant combined treatment by abiraterone acetate, prednisolone and GnRH agonist - in treatment naïve high-risk localised prostate carcinoma patients (prior to radical radiotherapy).
    Protection of trial subjects
    This clinical study was designed, implemented, and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations SI 190 of 2004 as amend and European Directive 2001/20/EC. The study was approved by the HPRA and Clinical REC of the Cork Teaching Hospital.
    Background therapy
    		 Prednisolone and GnRH agonist injection(s) are non IMP treatments/therapies used in this study. These are mandatory standard supportive care concomitant medication
    Evidence for comparator
    		 The role of the proposed study is to focus on the potential role of abiraterone acetate in treatment-naïve patients newly diagnosed with high-risk localised prostate cancer requiring combined hormonal therapy and radiotherapy (External Beam Radiation Therapy and/or Brachytherapy). This was a single-arm, Phase II prospective study with a primary efficacy objective of evaluating 126 days of neo-adjuvant hormonal therapy by abiraterone acetate (plus prednisolone) and GnRH agonist in high-risk localised prostate carcinoma.
    Actual start date of recruitment
    01 Jun 2015
    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
    Ireland: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    9
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 45 Participants were consented from Ireland from July-2015 to March-2020

    Pre-assignment
    Screening details
    		 This study will involve patients undergoing neo-adjuvant hormonal therapy for localised prostate carcinoma. All patients will fulfil the eligibility criteria

    Pre-assignment period milestones
    Number of subjects started
    		 45
    Number of subjects completed
    		 45

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was a single arm non blinded study

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 A single arm study where all patients will receive IMP Abiraterone acetate for 126 as well as Mandatory standard supportive care concomitant medication (nIMP): Prednisolone for 126 days and GnRH agonist for a minimum of 112 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abiraterone acetate
    Investigational medicinal product code
    Other name
    Zytiga
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg/day - four 250 mg tablets, orally once a day (unless otherwise instructed by the study doctor in the case of a dose adjustment) for 126 days - commencing 14 days prior to 1st GnRH agonist injection.

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Deltacortril®, Deltastab®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg/day (orally once a day, concomitant to abiraterone acetate) for 126 days - commencing 14 days prior to 1st GnRH agonist injection. [Following the 126 days of treatment, prednisolone dose should be gradually reduced at clinician’s advice to avoid patient withdrawal symptoms]. Prednisolone is being used to manage mineralocorticoid excess; abiraterone acetate is always taken with low-dose prednisolone.

    Investigational medicinal product name
    GnRH agonist:
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    First injection should be administered 14 days after first dose of concomitant abiraterone acetate (and prednisolone) and continued throughout the study for minimum duration of 112 days (e.g. either four one-monthly injections at 28-day intervals, or two x 3-monthly injections, or one 6-monthly injection - per Investigator’s choice). GnRH agonist is being used in this study as a standard treatment, therefore continuing this treatment beyond 112 days is the investigator decision and should be managed as per standard practice.

    Number of subjects in period 1
    		Single Arm
    Started
    45
    Completed
    44
    Not completed
    1
         Withdrawn, prohibited medication
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 45 45
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 37 37
    Age continuous
    Units: years
        median (full range (min-max))
    		 69 (57 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 45 45

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 A single arm study where all patients will receive IMP Abiraterone acetate for 126 as well as Mandatory standard supportive care concomitant medication (nIMP): Prednisolone for 126 days and GnRH agonist for a minimum of 112 days

    Subject analysis set title
    Single Arm Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    As this is a 1 armed study this statistical arm is created as a workaround so that statistical anlysis of the study can be posted

    Primary: Tumour Response: Mean % Reduction in Prostatic Gland Volume

    		 Close Top of page
    End point title
    		 Tumour Response: Mean % Reduction in Prostatic Gland Volume
    End point description
    Tumour Response at 126 was assessed 3 ways. This is the first way: Mean % Reduction in Prostatic Gland Volume: The mean prostatic volume at baseline was 45.8 cm3, with a median of 38.1 cm3 (range of 30.2 - 102). The mean reduction from baseline at Day 99 was 19.6 cm3, with a median of 17.4 cm3 (range of 7.2 – 77.4). The mean percentage reduction from baseline at Day 99 was 42.4%, with a median of 42.3% (range of 21.2 – 75.9). The 95% CI for mean percentage reduction from baseline at Day 99 was [38.6 - 46.2]. This is consistent with the assumption in Section 4 that the mean percentage reduction was expected to be at least 35% and no greater than 46%. In addition, 29/42 patients (69.0%) had prostatic volume within the range 20 – 50 cm3 at baseline, decreasing slightly to 23/36 (63.9%) at Day 99.
    End point type
    Primary
    End point timeframe
    Baseline to Day 99 to Day 126
    End point values
    		 Single Arm Single Arm Study
    Number of subjects analysed
    42 [1]
    42 [2]
    Units: cm3
    median (full range (min-max))
        Baseline
    38.1 (30.2 to 102.0)
    38.1 (30.2 to 102.0)
        Day 99
    22.2 (13.2 to 62.7)
    22.2 (13.2 to 62.7)
        Day 126
    19.0 (16.7 to 21.0)
    19.0 (16.7 to 21.0)
    Notes
    [1] - Baseline n =42 Day 99 n=36 Day 126 n=4
    [2] - This set is used as a workaround for statistical analysis as this is a single arm study
    Statistical analysis title
    		 Percentage reduction in prostatic volume
    Comparison groups
    Single Arm v Single Arm Study
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Mean percentage reduction at D99 and CI
    Parameter type
    		 Median difference (final values)
    Point estimate
    42.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 38.6
         upper limit
    		 46.2
    Variability estimate
    Standard deviation
    Dispersion value
    11.2
    Notes
    [3] - Mean percentage reduction and confidence interval

    Primary: Tumour Response at 126 Days: Median Change in PSA Levels

    		 Close Top of page
    End point title
    		 Tumour Response at 126 Days: Median Change in PSA Levels [4]
    End point description
    Assessment 2 for Tumour Response at 126 days: Median Change in PSA Levels: One patient had screening assessment outside window and is excluded from the results. One further patient did not have a PSA assessment at Day 126. The median PSA at baseline was 14.1 ng/mL (range of 2.86 – 147.2), and the median reduction from baseline at Day 126 was 13.7 ng/mL (range of 3 – 146). A total of 33 patients (80.5%) achieved a PSA value of <0.1 ng/mL at Day 126.
    End point type
    Primary
    End point timeframe
    After 126 days as compared to Baseline (PSA prior to treatment and on Day 126)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: the statistical analysis for this endpoint doesn’t fit into the format provided but the median reduction from baseline in PSA at Day 126 was 13.7 ng/mL (range of 3 – 146).
    End point values
    		 Single Arm Single Arm Study
    Number of subjects analysed
    42 [5]
    42 [6]
    Units: ng/ML
    median (full range (min-max))
        Baseline
    14.1 (2.86 to 147.2)
    14.1 (2.86 to 147.2)
        Day 126
    0.05 (0.03 to 0.87)
    0.05 (0.03 to 0.87)
    Notes
    [5] - Baseline n=42 Day126 n=41
    [6] - This arm has been created as a workaround as this is only a single am study
    No statistical analyses for this end point

    Primary: Tumour Response at 126 Days: DRE and Complete Response

    		 Close Top of page
    End point title
    		 Tumour Response at 126 Days: DRE and Complete Response
    End point description
    Assessment 3 for measuring tumour response at 126 days: DRE and Complete Response: 1 patient had his screening examination outside window and his screening T stage of T1c is excluded from the table. 4 patients did not have an examination performed at Day 126. The most common category at baseline was T1c with 11 patients (26.2%), and the highest category was T3b with just one patient. All FAS patients were T1c or higher at baseline. At Day 126, 5 patients (13.2%) could not have their primary tumour assessed. The most common category was T1c with 12 patients (31.6%), with one patient achieving T0 and one patient having the highest category of T3a. A total of 19 patients (57.6% of the 33 patients with a Day 126 assessment of tumour) had normalisation of DRE (T1c or less). A total of 16 patients (48.5% of the 33 patients with a Day 126 assessment of tumour) had a complete clinical and biochemical response as defined by a normalisation of DRE and an achieved PSA <0.1 ng/ml on Day 126.
    End point type
    Primary
    End point timeframe
    Baseline vs Day 126
    End point values
    		 Single Arm Single Arm Study
    Number of subjects analysed
    42 [7]
    42 [8]
    Units: Percent
    number (not applicable)
        BL: T1c
    26.2
    26.2
        BL: T2
    2.4
    2.4
        BL: T2a
    7.1
    7.1
        BL: T2b
    16.7
    16.7
        BL: T2c
    21.4
    21.4
        BL: T3
    11.9
    11.9
        BL: T3a
    11.9
    2.4
        BL: T3b
    2.4
    2.6
        D126: T0
    2.6
    15.8
        D126: T1
    15.8
    31.6
        D126: T1C
    31.6
    2.6
        D126: T2
    5.3
    5.3
        D126: T2a
    2.6
    2.6
        D126: T2c
    5.3
    5.3
        D126: Y3
    13.2
    13.2
        D126: T3a
    2.6
    2.6
        D126: TX
    13.2
    13.2
        D126: T2b
    7.9
    7.9
    Notes
    [7] - Baseline (BL) n=42 Day 126 n=38
    [8] - This arm was created as a workaround as this is a single arm study
    Statistical analysis title
    		 Complete Clinical and Biochemical Response
    Statistical analysis description
    Response rate
    Comparison groups
    Single Arm v Single Arm Study
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    		 Complete clin & biochem response & CI
    Parameter type
    		 Response rate
    Point estimate
    48.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.5
         upper limit
    		 64.8
    Notes
    [9] - Response rate and confidence interval

    Secondary: Decrease in Testosterone Levels

    		 Close Top of page
    End point title
    		 Decrease in Testosterone Levels
    End point description
    The median testosterone at baseline was 16.1 nmol/L (range of 4.8 – 34.5). At Day 15, just 8 patients (18.6%) had a value > 1.7 nmol/l. The median reduction from baseline at Day 126 was 16.1 nmol/L (range of 4.4 – 34.4), a reduction that was first achieved at Day 43 and maintained through to Day 126.
    End point type
    Secondary
    End point timeframe
    Prior To Treatment & on Days 15, 43, 71, 99 and 126
    End point values
    		 Single Arm
    Number of subjects analysed
    43 [10]
    Units: Testosterone nmol/L
    median (full range (min-max))
        Baseline
    16.1 (4.80 to 34.5)
        Day 15
    0.40 (0.10 to 11.9)
        Day 43
    0.12 (0.05 to 0.45)
        Day 71
    0.15 (0.06 to 0.45)
        Day 99
    0.10 (0.05 to 0.40)
        Day 126
    0.15 (0.02 to 0.45)
    Notes
    [10] - Baseline & Day 15 n=43 Day 43,71,99,126 n=42
    No statistical analyses for this end point

    Secondary: PSA kinetics and response

    		 Close Top of page
    End point title
    		 PSA kinetics and response
    End point description
    End point type
    Secondary
    End point timeframe
    The PSA kinetics and response on the studied treatment evaluated by serial PSA measurements prior to treatment and on days 15, 43, 71, 99, and 126
    End point values
    		 Single Arm
    Number of subjects analysed
    42 [11]
    Units: ng/ML
    median (full range (min-max))
        Baseline
    14.1 (2.86 to 147.2)
        Day 126
    0.05 (0.03 to 0.87)
    Notes
    [11] - Baseline =42, Day 126=41
    No statistical analyses for this end point

    Secondary: Impact on Urinary Symptoms

    		 Close Top of page
    End point title
    		 Impact on Urinary Symptoms
    End point description
    The studied treatment impact on urinary symptoms evaluated by serial International Prostate Symptom Score (IPSS) prior to treatment and on days 15, 43, 71, 99, and 126. The IPSS total score is calculated across 7 symptoms scores, with a maximum possible total score of 35. The median total score at baseline was 9.0 (range of 0 – 32), and the median change from baseline at Day 126 was -1.0 (range of -30 – 10), indicating a minimal change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Days 15, 43, 71, 99, and 126
    End point values
    		 Single Arm
    Number of subjects analysed
    43 [12]
    Units: IPSS Score
    median (full range (min-max))
        Baseline
    9.0 (0 to 32)
        Day 15
    7.0 (0 to 26)
        Day 43
    7.0 (0 to 26)
        day 71
    7.0 (0 to 20)
        Day 99
    5.5 (1 to 19)
        Day 126
    4.0 (1 to 18)
    Notes
    [12] - Baseline & Day 15 n=43 Day 43, 71, 99 n=42 Day 126 n=41
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Beginning on or after the start date of study treatment and up to 30 days after the end of study treatment
    Adverse event reporting additional description
    Evaluations include periodic physical examination, vital sign measurement, and clinical lab tests. (cardiac function may be assessed by MUGA scan or ECHO) AEs/ toxicities, incl. lab AEs, are graded and summarised. Any clinically significant abnormalities persisting at EoS will be followed until resolution or clinically stable endpoint reached.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 A single arm study where all patients will receive IMP Abiraterone acetate for 126 as well as Mandatory standard supportive care concomitant medication (nIMP): Prednisolone for 126 days and GnRH agonist for a minimum of 112 days

    Serious adverse events
    		 Single Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 45 (8.89%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Single Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 45 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    36 / 45 (80.00%)
         occurrences all number
    51
    Hypertension
         subjects affected / exposed
    26 / 45 (57.78%)
         occurrences all number
    60
    Hypotension
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    18 / 45 (40.00%)
         occurrences all number
    31
    Influenza like illness
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    4
    Oedema peripheral
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Ejaculation disorder
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Erectile dysfunction
         subjects affected / exposed
    9 / 45 (20.00%)
         occurrences all number
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    3
    Dyspnoea
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3
    Depression
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    7 / 45 (15.56%)
         occurrences all number
    8
    Libido decreased
         subjects affected / exposed
    9 / 45 (20.00%)
         occurrences all number
    11
    Loss of libido
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Mood swings
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    21 / 45 (46.67%)
         occurrences all number
    50
    Aspartate aminotransferase increased
         subjects affected / exposed
    20 / 45 (44.44%)
         occurrences all number
    46
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Blood bilirubin increased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    2
    Blood cholesterol increased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Blood urea increased
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Cardiac murmur
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Haematocrit decreased
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Haemoglobin decreased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    6
    Red blood cell count decreased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Cognitive disorder
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    4
    Dysgeusia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Memory impairment
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Dry Eye
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Abdominal Pain
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3
    Anal Incontinence
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    5 / 45 (11.11%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    4
    Dry Mouth
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3
    Flatulence
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Haematochezia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    5
    Proctalgia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Night sweats
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Skin induration
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Dysuria
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Lower urinary tract symptoms
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Micturition urgency
         subjects affected / exposed
    6 / 45 (13.33%)
         occurrences all number
    8
    Nocturia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Pollakiuria
         subjects affected / exposed
    9 / 45 (20.00%)
         occurrences all number
    10
    Urinary hesitation
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Urinary retention
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    3
    Urine flow decreased
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    4
    Groin pain
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Joint swelling
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Muscle atrophy
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Muscular weakness
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    2
    Myopathy
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    4
    Infections and infestations
    Gingivitis
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    2
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    3
    Onychomycosis
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Dehydration
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    4
    Hyperkalaemia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    4 / 45 (8.89%)
         occurrences all number
    5
    Increased appetite
         subjects affected / exposed
    2 / 45 (4.44%)
         occurrences all number
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2016
    First Approved Protocol V3.0 24-Jun-2014: This Amendment was for Protocol V4.0/01-APr-2016: The protocol was amended to clarify the RSI to be used in this study.
    28 Sep 2016
    Protocol v5.0 05Sept2016: Rationale for all protocol changes detailed in summary of Amendment Protocol V4.0 to V5.0. Includes update of ICORG to Cancer Trials Ireland , updates to abbreviations, admin updates, TRU assessment update, end point update
    16 Jan 2019
    Protocol V6.0/ 07-Dec-2018: Updates due to changes in conduct or mgmt of the trial. A key change to the protocol is the reduction of the follow up period to 6 months based on data reported from other trials, including the large international randomised phase III trials LATITUDE and STAMPEDE, which have demonstrated no significant concerns for late onset toxicities. Its safety profile is well characterised. The CI and study team therefore determine that 6 months follow up post last patient last treatment should provide an adequate duration of follow up and safety monitoring on this single arm phase II trial.
    24 Apr 2020
    Protocol V6.1/25Jun2019: updated to IB JNJ-212082 ZYTIGA Ed14 14Jun2019 led to non substantial amendments.

    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-Sun Apr 28 09:34:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA