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    Clinical Trial Results:
    Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer.

    Summary
    EudraCT number
    		 2006-000205-34
    Trial protocol
    		 GB   DK   IE  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jun 2023
    First version publication date
    07 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PR10
    Additional study identifiers
    ISRCTN number
    		 ISRCTN40814031
    US NCT number
    		 NCT00541047
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Gower St, London, United Kingdom, WC1E 6BT
    Public contact
    UCL Research Limited, UCL Research Limited, f.gilani@ucl.ac.uk
    Scientific contact
    UCL Research Limited, UCL Research Limited, f.gilani@ucl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To test whether adjuvant treatment with radiotherapy following radical postatectomy leads to better outcomes than regular observation with early salvage treatment given at the tune of a rising PSA - Radiotherapy Timing Randomisation. 2. To test whether, in men receiving post-operative radiotherapy to the prostate bed, the addition of hormone therapy leads to better outcomes; and if so, whether two years of hormone therapy is better than six months - Hormone Therapy Duration Randomisation
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 2007
    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
    United Kingdom: 2982
    Country: Number of subjects enrolled
    Denmark: 223
    Country: Number of subjects enrolled
    Ireland: 13
    Country: Number of subjects enrolled
    Canada: 747
    Worldwide total number of subjects
    3965
    EEA total number of subjects
    236
    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)
    1801
    From 65 to 84 years
    2164
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment between 30 January 2008 and 7 July 2015 for RADICALS-HD. Recruitment between 30 January 2008 and 31 December 2016 for RADICALS-RT.

    Pre-assignment
    Screening details
    		 Prostate cancer patients post-surgery

    Period 1
    Period 1 title
    RADICALS (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    None

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 RADICALS-HD, 0 months
    Arm description
    		 Hormone duration randomisation - no HT
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 RADICALS-HD, 6 months (0v6)
    Arm description
    		 6 mths treatment, none vs short comparison
    Arm type
    		 Experimental

    Investigational medicinal product name
    zoladex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Depot injection

    Arm title
    		 RADICALS-HD, 24 months
    Arm description
    		 Hormone duration randomisation - 24 months HT
    Arm type
    		 Experimental

    Investigational medicinal product name
    zoladex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Depot injection

    Arm title
    		 RADICALS-RT, Salvage
    Arm description
    		 RT timing randomisation - salvage RT
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 RADICALS-RT, Adjuvant
    Arm description
    		 RT timing randomisation - adjuvant RT
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 RADICALS-HD, 6 months (6v24)
    Arm description
    		 6 mths treatment, short vs long comparison
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		RADICALS-HD, 0 months RADICALS-HD, 6 months (0v6) RADICALS-HD, 24 months RADICALS-RT, Salvage RADICALS-RT, Adjuvant RADICALS-HD, 6 months (6v24)
    Started
    737
    743
    762
    699
    697
    761
    Completed
    737
    743
    762
    699
    697
    761

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RADICALS-HD, 0 months
    Reporting group description
    		 Hormone duration randomisation - no HT

    Reporting group title
    RADICALS-HD, 6 months (0v6)
    Reporting group description
    		 6 mths treatment, none vs short comparison

    Reporting group title
    RADICALS-HD, 24 months
    Reporting group description
    		 Hormone duration randomisation - 24 months HT

    Reporting group title
    RADICALS-RT, Salvage
    Reporting group description
    		 RT timing randomisation - salvage RT

    Reporting group title
    RADICALS-RT, Adjuvant
    Reporting group description
    		 RT timing randomisation - adjuvant RT

    Reporting group title
    RADICALS-HD, 6 months (6v24)
    Reporting group description
    		 6 mths treatment, short vs long comparison

    Reporting group values
    		 RADICALS-HD, 0 months RADICALS-HD, 6 months (0v6) RADICALS-HD, 24 months RADICALS-RT, Salvage RADICALS-RT, Adjuvant RADICALS-HD, 6 months (6v24) Total
    Number of subjects
    		 737 743 762 699 697 761 3965
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 312 315 342 332 343 352 1801
        From 65-84 years
    		 425 428 420 367 354 409 2164
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 66 (61 to 69) 65 (61 to 69) 65 (61 to 69) 65 (60 to 68) 65 (60 to 68) 65 (60 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0 0 0 0
        Male
    		 737 743 762 699 697 761 3965
    Subject analysis sets

    Subject analysis set title
    RADICALS-HD, 0months
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration comparison - none vs 6 months

    Subject analysis set title
    RADICALS-HD, 6 months (0v6)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration - 0 months vs 6 months

    Subject analysis set title
    RADICALS-HD, 24 months
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration comparison, short vs long

    Subject analysis set title
    RADICALS-RT, Salvage
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Radiotherapy timing comparison, salvage treatment

    Subject analysis set title
    RADICALS-RT, Adjuvant
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Radiotherapy timing comparison, adjuvant treatment

    Subject analysis set title
    RADICALS-HD, 6 months (6v24)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration comparison, short vs long

    Subject analysis sets values
    		 RADICALS-HD, 0months RADICALS-HD, 6 months (0v6) RADICALS-HD, 24 months RADICALS-RT, Salvage RADICALS-RT, Adjuvant RADICALS-HD, 6 months (6v24)
    Number of subjects
    737
    743
    762
    699
    697
    761
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    312
    315
    342
    332
    343
    352
        From 65-84 years
    425
    428
    420
    367
    354
    409
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    66 (61 to 69)
    65 (61 to 69)
    65 (61 to 69)
    65 (60 to 68)
    65 (60 to 68)
    65 (60 to 69)
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
    0
    0
    0
        Male
    737
    743
    762
    699
    697
    761

    End points

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    End points reporting groups
    Reporting group title
    RADICALS-HD, 0 months
    Reporting group description
    		 Hormone duration randomisation - no HT

    Reporting group title
    RADICALS-HD, 6 months (0v6)
    Reporting group description
    		 6 mths treatment, none vs short comparison

    Reporting group title
    RADICALS-HD, 24 months
    Reporting group description
    		 Hormone duration randomisation - 24 months HT

    Reporting group title
    RADICALS-RT, Salvage
    Reporting group description
    		 RT timing randomisation - salvage RT

    Reporting group title
    RADICALS-RT, Adjuvant
    Reporting group description
    		 RT timing randomisation - adjuvant RT

    Reporting group title
    RADICALS-HD, 6 months (6v24)
    Reporting group description
    		 6 mths treatment, short vs long comparison

    Subject analysis set title
    RADICALS-HD, 0months
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration comparison - none vs 6 months

    Subject analysis set title
    RADICALS-HD, 6 months (0v6)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration - 0 months vs 6 months

    Subject analysis set title
    RADICALS-HD, 24 months
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration comparison, short vs long

    Subject analysis set title
    RADICALS-RT, Salvage
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Radiotherapy timing comparison, salvage treatment

    Subject analysis set title
    RADICALS-RT, Adjuvant
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Radiotherapy timing comparison, adjuvant treatment

    Subject analysis set title
    RADICALS-HD, 6 months (6v24)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Hormone duration comparison, short vs long

    Primary: Distant metastases

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    End point title
    		 Distant metastases
    End point description
    RADICALS-HD: Metastasis-free survival - new distant metastasis or death from any cause RADICALS-RT: Freedom from distant metastasis - new distant metastasis or death from prostate cancer
    End point type
    Primary
    End point timeframe
    Randomisation to end of follow-up
    End point values
    		 RADICALS-HD, 0months RADICALS-HD, 6 months (0v6) RADICALS-HD, 24 months RADICALS-RT, Salvage RADICALS-RT, Adjuvant RADICALS-HD, 6 months (6v24)
    Number of subjects analysed
    737
    743
    762
    699
    697
    761
    Units: patients
    737
    743
    762
    699
    697
    761
    Statistical analysis title
    		 Metastasis free survival - HD 0 vs 6mths
    Statistical analysis description
    Primary outcome
    Comparison groups
    RADICALS-HD, 0months v RADICALS-HD, 6 months (0v6)
    Number of subjects included in analysis
    1480
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.346
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.886
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.688
         upper limit
    		 1.14
    Statistical analysis title
    		 Metastasis free survival - HD 6 vs 24mths
    Statistical analysis description
    Primary outcome
    Comparison groups
    RADICALS-HD, 6 months (6v24) v RADICALS-HD, 24 months
    Number of subjects included in analysis
    1523
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.773
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.612
         upper limit
    		 0.975
    Statistical analysis title
    		 Freedom from distant metastasis - RT timing
    Statistical analysis description
    Adjuvant RT vs Salvage RT
    Comparison groups
    RADICALS-RT, Salvage v RADICALS-RT, Adjuvant
    Number of subjects included in analysis
    1396
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.681
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.432
         upper limit
    		 1.072

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any time during follow-up
    Adverse event reporting additional description
    RTOG graded toxicities, grade 3 or above
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 RTOG
    Dictionary version
    1
    Reporting groups
    Reporting group title
    HD 0 months
    Reporting group description
    		 Hormone duration randomisation - no treatment

    Reporting group title
    HD 6 months, (0v6)
    Reporting group description
    		 Hormone duration randomisation - 6 months treatment short vs long

    Reporting group title
    HD 24 months
    Reporting group description
    		 Hormone duration randomisation - 2 years treatment

    Reporting group title
    RT salvage
    Reporting group description
    		 Radiotherapy timing randomisation - salvage strategy

    Reporting group title
    RT adjuvant
    Reporting group description
    		 Radiotherapy timing randomisation - adjuvant strategy

    Reporting group title
    HD 6 months, (6v24)
    Reporting group description
    		 Hormone duration randomisation, 6 months treatment, short vs long

    Serious adverse events
    		 HD 0 months HD 6 months, (0v6) HD 24 months RT salvage RT adjuvant HD 6 months, (6v24)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 737 (4.21%)
    30 / 743 (4.04%)
    50 / 762 (6.56%)
    15 / 697 (2.15%)
    32 / 699 (4.58%)
    30 / 761 (3.94%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 743 (0.13%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal cancer
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melanoma
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Stroke
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 743 (0.13%)
    3 / 762 (0.39%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina
         subjects affected / exposed
    1 / 737 (0.14%)
    5 / 743 (0.67%)
    1 / 762 (0.13%)
    1 / 697 (0.14%)
    2 / 699 (0.29%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 5
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    1 / 697 (0.14%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 737 (0.14%)
    3 / 743 (0.40%)
    4 / 762 (0.52%)
    2 / 697 (0.29%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    2 / 4
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 743 (0.13%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    3 / 762 (0.39%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Other
         subjects affected / exposed
    4 / 737 (0.54%)
    2 / 743 (0.27%)
    6 / 762 (0.79%)
    5 / 697 (0.72%)
    5 / 699 (0.72%)
    4 / 761 (0.53%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 6
    0 / 5
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Collapse
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    1 / 697 (0.14%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    1 / 697 (0.14%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    2 / 762 (0.26%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 737 (0.14%)
    1 / 743 (0.13%)
    1 / 762 (0.13%)
    1 / 697 (0.14%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cholecystitis
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    1 / 697 (0.14%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small bowel obstruction
         subjects affected / exposed
    1 / 737 (0.14%)
    1 / 743 (0.13%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal ulcer
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 743 (0.13%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    2 / 761 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 743 (0.13%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    2 / 761 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 743 (0.13%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    9 / 737 (1.22%)
    4 / 743 (0.54%)
    10 / 762 (1.31%)
    2 / 697 (0.29%)
    7 / 699 (1.00%)
    3 / 761 (0.39%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
    0 / 10
    0 / 2
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    1 / 697 (0.14%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stricture
         subjects affected / exposed
    3 / 737 (0.41%)
    4 / 743 (0.54%)
    5 / 762 (0.66%)
    0 / 697 (0.00%)
    5 / 699 (0.72%)
    6 / 761 (0.79%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    1 / 5
    0 / 0
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    3 / 737 (0.41%)
    0 / 743 (0.00%)
    4 / 762 (0.52%)
    0 / 697 (0.00%)
    3 / 699 (0.43%)
    2 / 761 (0.26%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 7
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary sepsis
         subjects affected / exposed
    1 / 737 (0.14%)
    2 / 743 (0.27%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    2 / 761 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute renal failure
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    2 / 762 (0.26%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    3 / 761 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Cystitis
         subjects affected / exposed
    1 / 737 (0.14%)
    2 / 743 (0.27%)
    2 / 762 (0.26%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Crushed vertebra
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    0 / 762 (0.00%)
    0 / 697 (0.00%)
    1 / 699 (0.14%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 743 (0.00%)
    1 / 762 (0.13%)
    0 / 697 (0.00%)
    0 / 699 (0.00%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HD 0 months HD 6 months, (0v6) HD 24 months RT salvage RT adjuvant HD 6 months, (6v24)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    121 / 737 (16.42%)
    100 / 743 (13.46%)
    142 / 762 (18.64%)
    67 / 697 (9.61%)
    116 / 699 (16.60%)
    105 / 761 (13.80%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 737 (1.76%)
    13 / 743 (1.75%)
    13 / 762 (1.71%)
    6 / 697 (0.86%)
    16 / 699 (2.29%)
    10 / 761 (1.31%)
         occurrences all number
    13
    13
    13
    6
    16
    10
    Proctitis
         subjects affected / exposed
    23 / 737 (3.12%)
    20 / 743 (2.69%)
    25 / 762 (3.28%)
    5 / 697 (0.72%)
    15 / 699 (2.15%)
    16 / 761 (2.10%)
         occurrences all number
    23
    20
    25
    5
    15
    16
    Renal and urinary disorders
    Cystitis
         subjects affected / exposed
    17 / 737 (2.31%)
    19 / 743 (2.56%)
    23 / 762 (3.02%)
    10 / 697 (1.43%)
    20 / 699 (2.86%)
    13 / 761 (1.71%)
         occurrences all number
    17
    19
    23
    10
    20
    13
    Haematuria
         subjects affected / exposed
    53 / 737 (7.19%)
    30 / 743 (4.04%)
    53 / 762 (6.96%)
    10 / 697 (1.43%)
    47 / 699 (6.72%)
    41 / 761 (5.39%)
         occurrences all number
    53
    30
    53
    10
    47
    41
    Urethral stricture
         subjects affected / exposed
    52 / 737 (7.06%)
    58 / 743 (7.81%)
    75 / 762 (9.84%)
    46 / 697 (6.60%)
    66 / 699 (9.44%)
    57 / 761 (7.49%)
         occurrences all number
    52
    58
    75
    46
    66
    57

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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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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