Impact of anticholinergic treatment on urinary discomfort during radiotherapy for prostate cancer

Phase 1

• Conditions: MedDRA version: 18.1Level: HLTClassification code 10004995Term: Bladder and urethral symptomsSystem Organ Class: 100000004857; Symptomatology related to acute urinary toxicity occuring during prostate irradiation in patients suffering from prostate cancer.; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2014-004296-22-FR
• Lead Sponsor: Centre Eugène Marquis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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 :
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified