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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

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    Clinical Trial Results:
    Immediate or early salvage post-operative external radiotherapy combined with concomitant and adjuvant hormonal treatment versus immediate or early salvage post-operative external radiotherapy alone in pT3a-b R0-1 cNOMO/pT2R1 cN0M0, Gleason score 5-10 prostatic carcinoma. A phase III study.

    Summary
    EudraCT number
    2006-002772-17
    Trial protocol
    NL   BE   FR   ES  
    Global end of trial date
    05 Jan 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jul 2020
    First version publication date
    09 Jul 2020
    Other versions
    Summary report(s)
    Short report

    Trial information

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    Trial identification
    Sponsor protocol code
    22043-30041
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00949962
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    European Organisation for Research and Treatment of Cancer
    Sponsor organisation address
    Avenue E. Mounier 83/11, Brussels, Belgium, 1200
    Public contact
    Project, Budget and Regulatory Dept, European Organisation for Research and Treatment of Cancer, +32 27441062, regulatory@eortc.be
    Scientific contact
    Project, Budget and Regulatory Dept, European Organisation for Research and Treatment of Cancer, +32 27441062, regulatory@eortc.be
    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
    18 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the potential benefit, in terms of biochemical progression free survival, of a combined adjuvant treatment consisting of short term androgen suppression in addition to postoperative RT in comparison to post-operative RT alone. Due to the small number of patients, no formal analysis of the trial endpoints can be performed as stand alone.
    Protection of trial subjects
    The responsible investigator ensured that this study was conducted in agreement with either the Declaration of Helsinki (available on the World Medical Association web site (http://www.wma.net)) and/or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol had been written, and the study was conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice (ICH-GCP, available online at http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf). The protocol was approved by the competent ethics committee(s) as required by the applicable national legislation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Oct 2009
    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
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Belgium: 13
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Switzerland: 8
    Worldwide total number of subjects
    86
    EEA total number of subjects
    78
    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)
    51
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Trial opened to recruitment on 06/10/2009 and was prematurely closed on 12/08/2013, due to lack of recruitment, with only 86 randomised patients (out of 600 planned to be recruited) from 19 sites in 6 countries.

    Pre-assignment
    Screening details
    Before Surgery: - cT1-2-3a, cN0M0 - PSA <= 30 ng/ml - WHO 0-1 - Age <= 80 years

    Pre-assignment period milestones
    Number of subjects started
    86
    Number of subjects completed
    86

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm I
    Arm description
    Patients undergo post-operative conformal external beam irradiation (immediate post-operative or salvage) for approximately 6.5 to 8 weeks.
    Arm type
    Comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Arm II
    Arm description
    Patients undergo post-operative conformal external beam irradiation (immediate post-operative or salvage) for approximately 6.5 to 8 weeks, plus one injection of ELIGARD 45 mg 6-month depot and the required pretreatment with anti-androgens.
    Arm type
    Experimental

    Investigational medicinal product name
    ELIGARD® 45mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose: ELIGARD® 45 mg delivers 45 mg of leuprorelin acetate over a 6-month period. Route of administration: subcutaneous injection.

    Number of subjects in period 1
    Arm I Arm II
    Started
    44
    42
    Completed
    35
    31
    Not completed
    9
    11
         Patient stopped without giving any reasons
    1
    -
         Serious adverse event before receiving ELIGARD.
    -
    1
         Anti-androgen not given.
    -
    2
         Radiation therapy not documented.
    -
    8
         Radiation therapy not documented
    8
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm I
    Reporting group description
    Patients undergo post-operative conformal external beam irradiation (immediate post-operative or salvage) for approximately 6.5 to 8 weeks.

    Reporting group title
    Arm II
    Reporting group description
    Patients undergo post-operative conformal external beam irradiation (immediate post-operative or salvage) for approximately 6.5 to 8 weeks, plus one injection of ELIGARD 45 mg 6-month depot and the required pretreatment with anti-androgens.

    Reporting group values
    Arm I Arm II Total
    Number of subjects
    44 42 86
    Age categorical
    Units: Subjects
        < 65 years
    23 28 51
        >= 65 years
    21 14 35
    Gender categorical
    Units: Subjects
        Male
    44 42 86
    WHO Performance status
    Units: Subjects
        WHO: 0
    39 37 76
        WHO: 1
    5 5 10
    Clinical stage - T
    Units: Subjects
        cT1c
    21 19 40
        cT2a
    7 11 18
        cT2b
    8 4 12
        cT2c
    5 6 11
        cT3a
    3 2 5
    Gleason Sum
    Sum of Gleason Pattern 1 and Gleason Pattern 2.
    Units: Subjects
        <=6
    8 7 15
        3+4
    18 18 36
        4+3
    9 10 19
        >7
    9 7 16
    Pre-operative PSA level
    PSA level measured as "ng/ml" (i.e. nanograms of PSA per milliliter (ng/mL) of blood).
    Units: ng/ml
        median (full range (min-max))
    7.0 (4.3 to 22.0) 8.6 (2.4 to 30.0) -

    End points

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    End points reporting groups
    Reporting group title
    Arm I
    Reporting group description
    Patients undergo post-operative conformal external beam irradiation (immediate post-operative or salvage) for approximately 6.5 to 8 weeks.

    Reporting group title
    Arm II
    Reporting group description
    Patients undergo post-operative conformal external beam irradiation (immediate post-operative or salvage) for approximately 6.5 to 8 weeks, plus one injection of ELIGARD 45 mg 6-month depot and the required pretreatment with anti-androgens.

    Primary: Biochemical progression free survival

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    End point title
    Biochemical progression free survival [1]
    End point description
    Biochemical failure (or PSA progression) is defined by a post-treatment PSA measurement that is ≥ 0.4 ng/ml and is confirmed by a second increasing measurement at least 4 weeks later. For patients in the early salvage setting, post-treatment PSA failure will be declared as above but patients in whom the PSA remains ≥ 0.4 ng/ml at the 6 month follow-up visit (approximately 4.5 months after end of RT) will be considered having had a PSA failure at that visit.
    End point type
    Primary
    End point timeframe
    Biochemical progression free survival is counted from the day of randomization to the day of first record of either biochemical failure, clinical progression, administration of a new (systemic) treatment for prostate cancer or death due to any cause.
    Notes
    [1] - 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: No statistical analyses was done for the primary endpoint because the trial was prematurely ended.
    End point values
    Arm I Arm II
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: % at 5 year
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - No statistical analyses was done for the primary endpoint because the trial was prematurely ended.
    [3] - No statistical analyses was done for the primary endpoint because the trial was prematurely ended.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected at baseline, during radiotherapy, at month 3 (approximately 6 weeks after end of radiotherapy) and during follow-up (6 months after randomization, then 6 months for the first 5 years and yearly thereafter).
    Adverse event reporting additional description
    CRF for AEs contains pre-specified items. (1.2% AEs are reported as "other" and are not reported as not available from the list of SOC). Note that AEs related to hematology and biochemistry lab values were not specifically collected and are not included in the table below.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Arm I
    Reporting group description
    -

    Reporting group title
    Arm II
    Reporting group description
    -

    Serious adverse events
    Arm I Arm II
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 44 (2.27%)
    2 / 42 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    ANASTOMOTIC STENOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    HAEMATURIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETHRAL MEATUS STENOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY RETENTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Arm I Arm II
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 44 (95.45%)
    42 / 42 (100.00%)
    Vascular disorders
    THROMBOSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    MOTOR NERVE LESION POSTSURGERY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    ABDOMEN NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    FATIGUE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    13 / 44 (29.55%)
    11 / 42 (26.19%)
         occurrences all number
    27
    16
    INSOMNIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    4
    OBESITY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    PELVIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    3 / 44 (6.82%)
    3 / 42 (7.14%)
         occurrences all number
    3
    3
    SWEATING
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    WEIGHT GAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    EJACULATORY DYSFUNCTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    ERECTILE DYSFUNCTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    39 / 44 (88.64%)
    36 / 42 (85.71%)
         occurrences all number
    209
    203
    GYNECOMASTIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 44 (4.55%)
    4 / 42 (9.52%)
         occurrences all number
    2
    5
    LIBIDO
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 44 (15.91%)
    18 / 42 (42.86%)
         occurrences all number
    15
    65
    TESTICLE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    1
    1
    Investigations
    WEIGHT LOSS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Cardiac disorders
    HYPERTENSION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    MYOCARDIAL ISCHEMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    4 / 42 (9.52%)
         occurrences all number
    0
    4
    Nervous system disorders
    DEPRESSION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    3
    DIZZINESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    2 / 42 (4.76%)
         occurrences all number
    1
    2
    NEURALGIA/PERIPHERAL NERVE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    1
    1
    NEUROPATHY MOTOR
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    3
    NEUROPATHY MOTOR PERIPHERAL POST SURGERY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    NEUROPATHY SENSORY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    NEUROPATIC PAIN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    EDEMA LIMB
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    6
    0
    LYMPHEDEMA-RELATED FIBROSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    1
    3
    LYMPHOCELE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    MALLEOLAR OEDEMA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    ANAL FISSURE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    COLITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    CONSTIPATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    2
    DIARRHEA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    17 / 44 (38.64%)
    18 / 42 (42.86%)
         occurrences all number
    25
    28
    ESOPHAGITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    FLATULENCE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 42 (0.00%)
         occurrences all number
    7
    0
    GASTROINTESTINAL COMPLAINTS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    HEMORRHAGE GI RECTUM
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    7 / 44 (15.91%)
    9 / 42 (21.43%)
         occurrences all number
    8
    11
    HEMORRHOIDS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 42 (2.38%)
         occurrences all number
    2
    1
    PROCTITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    16 / 44 (36.36%)
    11 / 42 (26.19%)
         occurrences all number
    26
    19
    RECTAL IRRITATION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    TENESMUS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    2
    Hepatobiliary disorders
    HEPATOBILIARY/PANCREAS GALBLADDER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    FLUSHING
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    2
    PRURITUS/ITCHING
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    2
    SKIN BREAKDOWN
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    CYSTITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    INCONTINENCE URINARY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    27 / 44 (61.36%)
    34 / 42 (80.95%)
         occurrences all number
    100
    118
    OBSTRUCTION GU URETER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    1
    3
    RENAL OTHER DYSURIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    11 / 44 (25.00%)
    9 / 42 (21.43%)
         occurrences all number
    19
    12
    RENAL OTHER HEMATURIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    5 / 44 (11.36%)
    5 / 42 (11.90%)
         occurrences all number
    7
    7
    STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC) GU BLA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC) GU URE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    URINARY FREQUENCY/URGENCY
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    32 / 44 (72.73%)
    22 / 42 (52.38%)
         occurrences all number
    75
    74
    URINARY RETENTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    8 / 44 (18.18%)
    6 / 42 (14.29%)
         occurrences all number
    15
    15
    Endocrine disorders
    HOT FLASHES/FLUSHES
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    26 / 42 (61.90%)
         occurrences all number
    2
    50
    Musculoskeletal and connective tissue disorders
    ARTHRITIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    FRACTURE
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    1
    1
    MUSCLE WEAKNESS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    OSTEOPOROSIS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    HERPES ZOSTER
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    PULMONARY INFECTION
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 42 (0.00%)
         occurrences all number
    1
    0
    URINARY TRACT NOS
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    ANOREXIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    0
    1
    HYPERCHOLESTEREMIA
    alternative dictionary used: CTCAE 3
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 42 (2.38%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2011
    The study was extremely poorly recruiting due to several reasons, which include delayed referral of patients to RT after surgery and different practices regarding adjuvant treatment of high risk prostate cancer patients. Among these recent developments of prostate cancer treatment the most important are considered utilization of early salvage treatment concept, increased utilization of sensitive PSA tests and higher RT doses and modern RT technologies. The changes proposed in the amendment are expected to enhance recruitment and enable the combined analysis with the ongoing RADICALS study. This was considered a scientific amendement (the proposed changes add a new stratum in the study and enlarge the patient eligibility criteria). The major scientific changes proposed: •Increase the time interval between surgery and the start of RT to maximum 26 weeks for the stratum “immediate post-operative adjuvant setting”. •Add a new stratum for patients treated in the “early post-operative salvage setting” i.e. upon post-operative PSA failure. Post-operative PSA failure was defined as either 2 consecutive increases of the PSA level and final PSA value >0.1 ng/ml and ≤0.5ng/ml or, in the case where the third PSA value is not >0.1ng/ml, by 3 consecutive rises of the PSA and a final PSA value ≤0.5ng/ml. •Allow cN0 patients with negative staging examinations (either CT or MRI of pelvis and abdomen) to be included in the protocol. •Increase pre-operative PSA upper limit from 20ng/ml (5xULN) to 30ng/ml. •Relax the requirements on the radiotherapy dose schedule. The sites will opt for their preferred RT regimen for each setting in a range of doses specified for each setting (between 64-70 Gy). Higher doses may also be acceptable pending feasibility, upfront dummy run and QART approval. •To better capture biochemical failure after protocol treatment, intermediate PSA values will be recorde between the visits (PSA to be taken every 3 months for up to 5 years and then every 6 months).

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    12 Aug 2013
    Trial was prematurely closed on 12/08/2013, due to lack of recruitment, with only 86 randomised patients (out of 600 planned to be recruited) from 19 sites in 6 countries.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Decision to end the trial prematurely due to poor recruitment.
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