EUCTR2014-004296-22-FR
Active, not recruiting
Phase 1
Anticholinergics impact in the treatment of acute irritative urinary toxicity during radiotherapy for prostate cancer - VesiCaP
Centre Eugène Marquis0 sitesDecember 7, 2015
ConditionsSymptomatology related to acute urinary toxicity occuring during prostate irradiation in patients suffering from prostate cancer.MedDRA version: 18.1Level: HLTClassification code 10004995Term: Bladder and urethral symptomsSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
DrugsVesicare®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Symptomatology related to acute urinary toxicity occuring during prostate irradiation in patients suffering from prostate cancer.
- Sponsor
- Centre Eugène Marquis
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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 \< 18
- •6\- Qmax \< 10 ml/sec at initial assessment, or post\-void residual urine \> 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 :
Outcomes
Primary Outcomes
Not specified
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