Clinical Trial Results:
Etude randomisée multicentrique comparant une radiothérapie adjuvante immédidate associée à une hormonothérapie courte par analogue LH-RH (Décapeptyl LP®) vs une radiothérapie différée à la rechute biochimique associée à une hormonothérapie courte par analogue LH-RH (Décapatyl LP®) chez les patients opérés d'un cancer de la prostate pT3 R1 pN0 ou pNX, de risque intermédiaire

Trial information Top of page
Trial identification
Sponsor protocol code	GETUG 17/0702
Additional study identifiers
ISRCTN number	ISRCTN00667069
US NCT number	NCT00667069
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	UNICANCER
Sponsor organisation address	101 rue de Tolbiac, Paris, France, 75013
Public contact	Nourredine AIT RAHMOUNE, UNICANCER, 33 0171936704, n.ait-rahmoune@unicancer.fr
Scientific contact	Nourredine AIT RAHMOUNE, UNICANCER, 33 0171936704, n.ait-rahmoune@unicancer.fr
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	19 Dec 2019
Is this the analysis of the primary completion data?	Yes
Primary completion date	31 Aug 2019
Global end of trial reached?	Yes
Global end of trial date	24 Jul 2022
Was the trial ended prematurely?	Yes
General information about the trial
Main objective of the trial	To compare the efficacy of aRT combined with hormonal therapy immediately after RP to sRTcombined with hormonal therapy at biochemical relapse.
Protection of trial subjects	This study was conducted in accordance with the Declaration of Helsinki (1964) and subsequent amendments, ICH Good Clinical Practice (GCP) Guidelines (CPMP/ICH/135/95), the European Directive (2001/20/CE) and the applicable local regulatory requirements and laws.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	07 Apr 2008
Long term follow-up planned	Yes
Long term follow-up rationale	Safety, Efficacy
Long term follow-up duration	5 Years
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	France: 424
Worldwide total number of subjects	424
EEA total number of subjects	424
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)	240
From 65 to 84 years	184
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	The trial planned to enrol 718 patients, 359 in each study arm. However, an independent data monitoring committee held on the 20-May-2016 recommended that accrual be stopped. Finally, the trial enrolled 424 patients: 212 in the aRT Arm and 212 in the sRT Arm. The first patient was randomised on 07/04/2008.
Pre-assignment
Screening details	Randomisation was performed at least 3 months and at the latest 6 months after radical prostatectomy. At randomisation, it was necessary to verify that the PSA level post-intervention was ≤0.1 ng/mL at two dosages, 2 months apart, for patient eligibility.
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	aRT Arm
Arm description	In the aRT Arm, hormonal therapy was planned to start within the 2 months before RT. The initiation of RT was planned between 3 and 6 months after RP.
Arm type	Experimental
Investigational medicinal product name	Triptorelin (Decapeptyl® )
Investigational medicinal product code
Other name
Pharmaceutical forms	Powder and solution for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	One injection every 3 months for 6 months, i.e., 2 injections
Arm title	sRT Arm
Arm description	In the sRT Arm, RT combined with hormonal therapy (identical to the aRT Arm) was initiated once biochemical relapse had occurred.
Arm type	Active comparator
Investigational medicinal product name	Triptorelin (Decapeptyl® )
Investigational medicinal product code
Other name
Pharmaceutical forms	Powder and solution for suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	One injection every 3 months for 6 months, i.e., 2 injections
Number of subjects in period 1 aRT Arm sRT Arm Started 212 212 Completed 198 107 Not completed 14 105      Refused Radiotherapy 1 -      Patient decision - 1      Lost to follow up - 2      Toxicity 1 2      Death 1 -      Did not receive hormonal therapy 3 1      Consent withdrawn 4 2      Missing data 4 97

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	aRT Arm
Reporting group description	In the aRT Arm, hormonal therapy was planned to start within the 2 months before RT. The initiation of RT was planned between 3 and 6 months after RP.
Reporting group title	sRT Arm
Reporting group description	In the sRT Arm, RT combined with hormonal therapy (identical to the aRT Arm) was initiated once biochemical relapse had occurred.
Reporting group values aRT Arm sRT Arm Total Number of subjects 212 212 424 Age categorical Units: Subjects     In utero 0 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0 0     Newborns (0-27 days) 0 0 0     Infants and toddlers (28 days-23 months) 0 0 0     Children (2-11 years) 0 0 0     Adolescents (12-17 years) 0 0 0     Adults (18-64 years) 116 124 240     From 65-84 years 96 88 184     85 years and over 0 0 0 Age continuous Age at randomisation (years) Units: years     median (full range (min-max)) 63.0 (44 to 76) 63.0 (36 to 77) - Gender categorical Units: Subjects     Female 0 0 0     Male 212 212 424 PT3AOUB Units: Subjects     pT3A ou pT4 168 168 336     pT3B 44 44 88 GRADE Units: Subjects     Grade 4 non prédominant 138 137 275     Grade 4 prédominant 74 75 149 ECOG performance status Units: Subjects     ECOG 0 195 194 389     ECOG 1 12 13 25     Missing data 5 5 10 Gleason score Units: Subjects     Gleason score 3 0 1 1     Gleason score 5 1 0 1     Gleason score 6 20 21 41     Gleason score 7 173 167 340     Gleason score 8 12 16 28     Gleason score 9 5 7 12     Missing data 1 0 1 pT-staging Units: Subjects     pT3a 163 163 326     pT3b 45 43 88     pT4 (bladder neck) 3 5 8     Missing data 1 1 2 pN-staging Units: Subjects     pN0 153 151 304     pNx 58 61 119     Missing data 1 0 1 Positive surgical margins Units: Subjects     No 0 2 2     Yes 211 210 421     Missing data 1 0 1 Seminal vesicles invasion Units: Subjects     Non-invaded 167 165 332     Invaded 44 46 90     Missing data 1 1 2 Age at prostatectomy Units: Years     median (full range (min-max)) 63.4 (0 to 77) 63.7 (-1 to 76) - Time interval since prostatectomy Units: Months     median (full range (min-max)) 3.4 (1 to 7) 3.4 (1 to 8) -

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	aRT Arm
Reporting group description	In the aRT Arm, hormonal therapy was planned to start within the 2 months before RT. The initiation of RT was planned between 3 and 6 months after RP.
Reporting group title	sRT Arm
Reporting group description	In the sRT Arm, RT combined with hormonal therapy (identical to the aRT Arm) was initiated once biochemical relapse had occurred.

End points Top of page

Primary: EFS rate at 5 years Top of page
End point title	EFS rate at 5 years
End point description
End point type	Primary
End point timeframe	5 years after randomisation
End point values aRT Arm sRT Arm Number of subjects analysed 212 212 Units: percent     number (confidence interval 95%) 92 (86 to 95) 90 (85 to 94)
Statistical analysis title	EFS rate analysis
Comparison groups	sRT Arm v aRT Arm
Number of subjects included in analysis	424
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 42
Method	Logrank
Parameter type	Hazard ratio (HR)
Point estimate	0.81
Confidence interval
level	95%
sides	2-sided
lower limit	0.48
upper limit	1.36

Primary: EFS rate at 5 years Top of page

Secondary: OS rate at 5 years Top of page
End point title	OS rate at 5 years
End point description
End point type	Secondary
End point timeframe	5 years after randomisation
End point values aRT Arm sRT Arm Number of subjects analysed 212 212 Units: percent     number (confidence interval 95%) 96 (92 to 98) 99 (96 to 100)
Statistical analysis title	OS rate analysis
Comparison groups	aRT Arm v sRT Arm
Number of subjects included in analysis	424
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.25
Method	Logrank
Parameter type	Hazard ratio (HR)
Point estimate	1.6
Confidence interval
level	95%
sides	2-sided
lower limit	0.71
upper limit	3.6

Secondary: OS rate at 5 years Top of page

Secondary: The mean global health status at baseline Top of page
End point title	The mean global health status at baseline
End point description
End point type	Secondary
End point timeframe	from baseline until December 2017
End point values aRT Arm sRT Arm Number of subjects analysed 212 212 Units: Number     log mean (standard deviation) 76.2 ( 19 ) 76.4 ( 19.4 )
No statistical analyses for this end point

Secondary: The mean global health status at baseline Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	The analysis of the incidence of AEs was divided into acute toxicities, those occurring during radiotherapy and within 3 months of completing radiotherapy, and late toxicities, those occurring after this period and during at most 5 years of follow up.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	24.1
Reporting groups
Reporting group title	aRT Arm
Reporting group description	-
Reporting group title	sRT Arm
Reporting group description	-
Serious adverse events aRT Arm sRT Arm Total subjects affected by serious adverse events      subjects affected / exposed 35 / 212 (16.51%) 37 / 212 (17.45%)      number of deaths (all causes) 14 10      number of deaths resulting from adverse events 1 2 Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon      subjects affected / exposed 2 / 212 (0.94%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 2 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Adenocarcinoma of kidney      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Adenocarcinoma of the cardia      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Adenocarcinoma pancreas      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Anal squamous cell carcinoma      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Carcinoma kidney      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Carcinoma larynx      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cholangiocarcinoma      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic lymphatic leukemia      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Chronic lymphoid leukaemia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Colon cancer      subjects affected / exposed 2 / 212 (0.94%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 1 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Colorectal cancer      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diffuse large B-cell lymphoma, unclassifiable, NOS      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Epidermoid carcinoma      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastric cancer      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Infiltrating ductal breast cancer      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung cancer      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Lung cancer metastatic      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Malignant melanoma      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Myelodysplasia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myelofibrosis      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Myeloma      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Neoplasm of unspecified nature of digestive system      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Non-small cell lung cancer      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Non-small cell lung cancer metastatic      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Pancreas cancer      subjects affected / exposed 2 / 212 (0.94%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 2 0 / 0 Pancreatic adenocarcinoma      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Rectal adenocarcinoma      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 1 Renal cancer metastatic      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 1 / 1 Thyroid carcinoma      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Urothelial carcinoma      subjects affected / exposed 0 / 212 (0.00%) 4 / 212 (1.89%)      occurrences causally related to treatment / all 0 / 0 2 / 4      deaths causally related to treatment / all 0 / 0 0 / 0 Urothelial carcinoma bladder      subjects affected / exposed 1 / 212 (0.47%) 3 / 212 (1.42%)      occurrences causally related to treatment / all 0 / 1 2 / 3      deaths causally related to treatment / all 0 / 0 0 / 0 Vascular disorders Arteritis obliterans      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Peripheral arterial disease      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Surgical and medical procedures Hip prosthesis insertion      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Orchidectomy      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 General disorders and administration site conditions Unknown cause of death      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Injury, poisoning and procedural complications Irradiation cystitis      subjects affected / exposed 1 / 212 (0.47%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 1 / 1 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Multiple fractures      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac disorders Angina at rest      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Cardiac insufficiency      subjects affected / exposed 2 / 212 (0.94%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Nervous system disorders Generalized tonic-clonic seizure      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Partial epilepsy      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Ear and labyrinth disorders Congenital deafness      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal disorders Bleeding rectal      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Diverticulitis      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Hernial eventration      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Inguinal hernia      subjects affected / exposed 1 / 212 (0.47%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Intestinal obstruction      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Hepatobiliary disorders Hepatic duct stenosis      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Renal and urinary disorders Acute retention of urine      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Cystitis radiation      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Dysuria      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Haematuria      subjects affected / exposed 1 / 212 (0.47%) 5 / 212 (2.36%)      occurrences causally related to treatment / all 1 / 1 5 / 5      deaths causally related to treatment / all 0 / 0 0 / 0 Stenosis of vesicourethral anastomosis      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Stenosis ureteral      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Urinary incontinence      subjects affected / exposed 2 / 212 (0.94%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Endocrine disorders Diabetes      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetes mellitus loss of control      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Diabetes with hyperosmolarity      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Musculoskeletal and connective tissue disorders Amyotrophy      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Infections and infestations Colonic abscess      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Community acquired pneumonia      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gangrenous cholecystitis      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events aRT Arm sRT Arm Total subjects affected by non serious adverse events      subjects affected / exposed 212 / 212 (100.00%) 212 / 212 (100.00%) Vascular disorders Hypertension      subjects affected / exposed 4 / 212 (1.89%) 3 / 212 (1.42%)      occurrences all number 1 1 Hypotension      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 General disorders and administration site conditions Hot flush      subjects affected / exposed 83 / 212 (39.15%) 36 / 212 (16.98%)      occurrences all number 1 1 Asthenia      subjects affected / exposed 41 / 212 (19.34%) 19 / 212 (8.96%)      occurrences all number 1 1 Pain      subjects affected / exposed 2 / 212 (0.94%) 0 / 212 (0.00%)      occurrences all number 1 0 Immune system disorders Hypersensitivity      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Reproductive system and breast disorders Erectile dysfunction      subjects affected / exposed 11 / 212 (5.19%) 7 / 212 (3.30%)      occurrences all number 1 1 Breast tenderness      subjects affected / exposed 4 / 212 (1.89%) 1 / 212 (0.47%)      occurrences all number 1 1 Gynecomastia      subjects affected / exposed 3 / 212 (1.42%) 2 / 212 (0.94%)      occurrences all number 1 1 Libido disorder      subjects affected / exposed 2 / 212 (0.94%) 0 / 212 (0.00%)      occurrences all number 1 0 Ejaculation disorder      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Testicular pain      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Respiratory, thoracic and mediastinal disorders Dyspnoea      subjects affected / exposed 0 / 212 (0.00%) 2 / 212 (0.94%)      occurrences all number 0 1 Dysphonia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Investigations Weight decreased      subjects affected / exposed 13 / 212 (6.13%) 3 / 212 (1.42%)      occurrences all number 1 1 Injury, poisoning and procedural complications Fracture      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Nervous system disorders Headache      subjects affected / exposed 3 / 212 (1.42%) 0 / 212 (0.00%)      occurrences all number 1 0 Paraesthesia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Presyncope      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Sciatica      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Gastrointestinal disorders Diarrhoea      subjects affected / exposed 60 / 212 (28.30%) 17 / 212 (8.02%)      occurrences all number 1 1 Proctitis      subjects affected / exposed 27 / 212 (12.74%) 6 / 212 (2.83%)      occurrences all number 1 1 Anal inflammation      subjects affected / exposed 22 / 212 (10.38%) 5 / 212 (2.36%)      occurrences all number 1 1 Flatulence      subjects affected / exposed 19 / 212 (8.96%) 8 / 212 (3.77%)      occurrences all number 1 1 Rectal haemorrhage      subjects affected / exposed 16 / 212 (7.55%) 5 / 212 (2.36%)      occurrences all number 1 1 Constipation      subjects affected / exposed 6 / 212 (2.83%) 8 / 212 (3.77%)      occurrences all number 1 1 Haemorrhoids      subjects affected / exposed 11 / 212 (5.19%) 2 / 212 (0.94%)      occurrences all number 1 1 Abdominal pain      subjects affected / exposed 5 / 212 (2.36%) 1 / 212 (0.47%)      occurrences all number 1 1 Anorectal discomfort      subjects affected / exposed 3 / 212 (1.42%) 1 / 212 (0.47%)      occurrences all number 1 1 Abdominal pain upper      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Aerophagia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Anal fissure      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Anal pruritus      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Ascites      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Bowel motility disorder      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Dyschezia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Dysphagia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Frequent bowel movements      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Gastroenteritis      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Gastrointestinal disorder      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Gastrointestinal motility disorder      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Gastrointestinal toxicity      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Gastrointestinal tract irritation      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Inguinal hernia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Intestinal obstruction      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Mucous stools      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Proctalgia      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Rectal tenesmus      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Mucosal inflammation      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Skin and subcutaneous tissue disorders Hyperhidrosis      subjects affected / exposed 18 / 212 (8.49%) 10 / 212 (4.72%)      occurrences all number 1 1 Rash      subjects affected / exposed 3 / 212 (1.42%) 2 / 212 (0.94%)      occurrences all number 1 1 Radiation skin injury      subjects affected / exposed 1 / 212 (0.47%) 2 / 212 (0.94%)      occurrences all number 1 1 Erythema      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Pruritus      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Skin burning sensation      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Skin hyperpigmentation      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Skin irritation      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Skin ulcer      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Renal and urinary disorders Pollakiuria      subjects affected / exposed 107 / 212 (50.47%) 38 / 212 (17.92%)      occurrences all number 1 1 Urinary incontinence      subjects affected / exposed 48 / 212 (22.64%) 10 / 212 (4.72%)      occurrences all number 1 1 Dysuria      subjects affected / exposed 32 / 212 (15.09%) 13 / 212 (6.13%)      occurrences all number 1 1 Micturition urgency      subjects affected / exposed 8 / 212 (3.77%) 5 / 212 (2.36%)      occurrences all number 1 1 Nocturia      subjects affected / exposed 7 / 212 (3.30%) 6 / 212 (2.83%)      occurrences all number 1 1 Cystitis radiation      subjects affected / exposed 4 / 212 (1.89%) 0 / 212 (0.00%)      occurrences all number 1 0 Micturition disorder      subjects affected / exposed 2 / 212 (0.94%) 1 / 212 (0.47%)      occurrences all number 1 1 Haematuria      subjects affected / exposed 1 / 212 (0.47%) 1 / 212 (0.47%)      occurrences all number 1 1 Urinary retention      subjects affected / exposed 2 / 212 (0.94%) 0 / 212 (0.00%)      occurrences all number 1 0 Musculoskeletal and connective tissue disorders Arthralgia      subjects affected / exposed 3 / 212 (1.42%) 1 / 212 (0.47%)      occurrences all number 1 1 Muscular weakness      subjects affected / exposed 2 / 212 (0.94%) 1 / 212 (0.47%)      occurrences all number 1 1 Back pain      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Bone pain      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Groin pain      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Neck pain      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 0 0 Infections and infestations Urinary tract infection      subjects affected / exposed 2 / 212 (0.94%) 2 / 212 (0.94%)      occurrences all number 1 1 Herpes zoster      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Nasopharyngitis      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0 Streptococcal infection      subjects affected / exposed 0 / 212 (0.00%) 1 / 212 (0.47%)      occurrences all number 0 1 Metabolism and nutrition disorders Type 2 diabetes mellitus      subjects affected / exposed 1 / 212 (0.47%) 0 / 212 (0.00%)      occurrences all number 1 0

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
28 Nov 2007	- Clarification of the primary objective. - Correction of the email address for randomisation. - Updating of the investigator list.
26 Mar 2008	- Clarification of the definition of biochemical relapse in the salvage radiotherapy (sRT) Arm. - Updating of the investigator list.
30 Jul 2008	- Updating of the investigator list.
25 Feb 2009	- Modification of the project leader - Updating of the investigator list.
24 Jun 2009	- Updating of the investigator list.
30 Sep 2009	- Updating of the investigator list
16 Dec 2009	- Lowering of the maximum PSA levels to initiate treatment in the sRT Arm from >2 ng/mL to >1 ng/mL. - Updating of the investigator list.
27 Jan 2010	- Updating of the investigator list.
31 Mar 2010	- Updating of the investigator list.
28 Jul 2010	- Updating of the investigator list.
30 Mar 2011	- Updating of the investigator list.
21 Dec 2011	- Changing of the promoter from Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) to Unicancer. Consequently, the study management team and all the contact details were also modified.
29 Feb 2012	- Updating of the investigator list.
12 Dec 2012	- Updating of the investigator list. - Prolongation of the inclusion period by 24 months, thus until December 2014.
28 Aug 2013	- Updating of the investigator list.
24 Feb 2014	- Updating of the investigator list. - Correction of errors in the protocol, corresponding to Amendment N°7.
29 Oct 2014	- Updating of the investigator list. - Correction of an error in the protocol.
25 Feb 2015	- Updating of the investigator list.
27 May 2015	- Updating of the investigator list.
29 Jul 2015	- Updating of the investigator list.
28 Oct 2015	- Updating of the investigator list.
27 Jan 2016	- Updating of the investigator list. - Prolongation of the inclusion period by 12 months.
28 Sep 2016	- Updating of the investigator list
27 Jul 2017	- Updating of the investigator list. - Collection of QLQ for all patients
27 Jun 2018	- Updating of the investigator list.
Interruptions (globally)
Were there any global interruptions to the trial? Yes
Date Interruption Restart date 20 May 2016 The GETUG-AFU 17 trial planned to enrol 718 patients, 359 in each study arm. However, an IDMC held on the 20-May-2016 recommended that accrual be stopped. The accrual was stopped, on the 23-Jun-2016, 424 patients had been randomly allocated: 212 to the aRT Arm and 212 to the sRT Arm. -
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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