Symptomatology related to acute urinary toxicity occuring during prostate irradiation in patients suffering from prostate cancer. MedDRA version: 18.1 Level: HLT Classification code 10004995 Term: Bladder and urethral symptoms System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Vesicare®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: solifenacin succinate
CAS Number: 242478-38-2
Other descriptive name: SOLIFENACIN SUCCINATE
Concentration unit: mg milligr
Sponsors
Centre Eugène Marquis
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Prostate localized adenocarcinoma (histological confirmation) - Indication for prostate cancer radiotherapy (standard scheme with a global dose between 70 and 80 Gy) - Patient affiliation to the French Social Security System - Free and written informed consent - Patients complaigning of urinary symptoms during irradiation - Occurrence of overactive bladder subscore with the USP scale greater to 5 during irradiation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1- Pelvic irradiation contraindication 2- History of bladder or prostate surgery 3- History of pelvic radiotherapy 4- Person deprived of freedom, under tutorship,guardianship, safeguarding of justice 5- Age 100 ml (during preinclusion urology visit) 7- Previous known Overactive Bladder 8- Patients treated with anticholinergic or anticholinesterasic within 12 months before irradiation 9- Patients treated with a-blocker, 5-alpha reductase inhibitors within 12 months before irradiation, 10- Contraindication of solifenacin succinate treatment : - patients suffering from urinary retention, severe gastrointestinal disease (including toxic megacolon), myasthenia or angle-closure glaucoma, as well as patients at risk against these diseases - patients suffering from hypersensitivity to active substance or to one of its excipients - hemodialyzed patients - patients suffering from severe hepatic insufficiency - patients suffering from severe renal or moderate hepatic insufficiency and who are treated with a strong inhibitor of iso-enzyme CYP3A4 as Ketoconazole 11- Hypersensitivity or allergy to another anticholinergic 12- Hereditary intolerance to galactose, lactase deficiency (Lapp) or syndrome of glucose and galactose malabsorption 13- Patients unable to follow study medical requirement for family, social, geographical or psychic reasons 14- Participation to a clinical trial on urinary toxicity and / or substance that could modify this toxicity and its evolution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main goal of the study is to assess solifenacin succinate efficacy on irritative urinary symptomatology occuring during prostate irridiation in patients suffering from prostate cancer.;Secondary Objective: To assess solifenacin succinate efficacy on non irritative symptoms and on global urinary symptomatology of patients during prostate irridiation. To assess solifenacin succinate efficacy on quality of live of patients having an irritative urinary syndrom during prostate irradiation. To describe qualitatively and quantitatively acute urinary toxicity during prostate irradiation in patients treated with anticholinergic. To assess solifenacin tolerance of patients during and after prostate irradiation.;Primary end point(s): The main goal of this study is to assess solifenacin succinate treatment on irritative urinary symptomatology occuring during prostate irradiation in patients suffering from prostate cancer;Timepoint(s) of evaluation of this end point: OAB score measured with USP scale, 6 weeks after start of anticholinergic treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess solifenacin succinate efficacy on non irritative symptoms and global urinary symptomatology of patients during irradiation To assess efficacy of solifenacin succinate on quality of life of patients with irritative urinary syndrom during irradiation To describe qualitatively and quantitatively acute urinary toxicity during prostate irradiation of patients treated with anticholinergic To assess safety of solifenacin succinate of patients during and after prostate irradiation ;Timepoint(s) of evaluation of this end point: - Urinary symptoms collection by patients with a voiding calendar at initiation, 6 weeks, 3 months and 6 months after treatment start - "Global" and "dysuria" scores measured with USP scale at initiation, 6 weeks, 3 months and 6 months after treatment start - Global score measured with IPSS scale at initiation, 6 weeks, 3 months and 6 months after treatment start - CTCAE V4 grades of urinary symptomatology (non irritative) at initiation, 6 weeks, 3 months and 6 months after treatment start - Quality of life scores (QLQC30, QLQ-PR25) at initiation, 6 weeks, 3 months and 6 months after treatment start - Frequency and grade according CTCAE V4 scale of the whole adverse events occured during the study | — |
Countries
France
Contacts
Public ContactMartine Gestin
Centre Eugène Marquis
Outcome results
None listed