- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02805452
Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer (VesiCaP)
Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A multicenter Phase III, randomized, double-blinded, parallel group placebo-controlled study.
2 groups:
- Control arm = pts. with placebo
- Experimental arm = pts. with Solifenacin succinate 5 mg - Vesicare® All patients with an OAB sub-score using the USP scale greater to 5 during prostate cancer radiotherapy will be included, receiving either a placebo or Solifenacin succinate (5mg) for duration of 3 months.
The randomization will be stratified on the radiotherapy dose (1 to 40 Gy or 40 to 70/80 Gy).
Screening:
For all patients, OAB items of the USP scale will be completed before each standard weekly assessment during prostate radiotherapy. Patients who reach an OAB sub-score greater to 5 will be addressed to an urologist in order to confirm absence of Qmax < 10ml/sec at initial assessment, or post-void residual urine > 100 milliliter (ml).
Inclusion & treatment:
A week at most after pre-screening, patients will be randomized to receive either Vesicare®-5mg or a placebo. In both study arms, the treatment should be continued for 3 months.
Follow-up:
The radiation oncologist will perform patients' follow-up for the study at the treatment initiation, 6 weeks and 3 months after start of the treatment (Vesicare or placebo).
The questionnaires for the evaluation of OAB syndrome, acute urinary toxicity and quality of life should be completed for each follow-up visit. The voiding diary will be completed during 3 days before (or if not, 3 days after) all the evaluation times.
An urologist will perform an uroflowmetry and a post-voiding echography (or a bladder scan) before initiation of the treatment, and after 6 weeks of treatment.
Statistics and sample size PATIENTS ENROLMENT 70 patients will be included (considering 66 patients completing the full study) within 3 recruitment centers
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Brest, France
- Clinique Pasteur Lanroze
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Lorient, France
- CH Bretagne Sud
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Lyon, France
- Ch Lyon Sud
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Paris, France
- Hôpital Saint Louis
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Rennes, France, 35042
- Centre Eugène Marquis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Prostate adenocarcinoma (histological confirmation),
- Indication for prostate cancer radiotherapy (standard schema with a total dose from 70 to 80 Gray (GY)),
- Patient affiliation to the French Social Security System,
- Patient information and written informed consent,
- Patient complaining of urinary symptoms during radiotherapy,
- Occurrence of OverActive Bladder (OAB) subscore with the Urinary Symptom Profile (USP) scale greater or equal to 5.
Exclusion Criteria:
- Prostate irradiation contraindication
- History of bladder or prostate surgery,
- History of of pelvic radiotherapy,
- Individual deprived of liberty or placed Under the authority of a tutor,
- Age < 18 years,
- Flowmetry Qmax < 10ml/s and/or post-void residual urine > 100 ml (during urology preinclusion visit)
- Previous known OAB
- Patients treated with non-authorized drugs,
- Patients treated with anticholinergic or cholinesterase inhibitors within 12 months before irradiation,
- Patients treated with anticholinergic during and weeks following irradiation and before Succinate of Solifenacin treatment start,
- Patients treated with botulinum toxin within 9 months before screening,
- Patients treated with alpha-blockers, 5-alpha reductase inhibitor within 12 months preceding irradiation, during and weeks following irradiation and before Succinate of Solifenacin treatment start,
- Contraindication of Succinate of Solifenacin
- Hypersensitivity or allergy to Solifenacin succinate or to any other antimuscarinic agent,
- Specific precautions of use for patients having decompensated urinary tract obstruction at risk of urinary retention, vegetative neuropathy, long QT syndrome and an hypokaliemia, history of long QT or patients at risk of QT prolongation, obstructive gastrointestinal disorders.
- Patients treated with oral biphosphonates, drugs that cause QT prolongation or by substrates having affinity for CYP3A4 isoenzyme as verapamil and Diltiazem, or treated with CYP3A4 inductors as rifampicin, phenytoin, carbamazepine
- Galactose hereditary intolerance, lactase deficiency or a malabsorption syndrome of glucose and galactose.
- Patient enable to follow study medical care for family, social, geographical or psychological reasons.
- Participation to another clinical study on urinary toxicity and/or molecule that could modify this toxicity and its evolution.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Succinate of Solifenacin
1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months.
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|
Placebo Comparator: Placebo of Succinate of Solifenacin
1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of Urinary Symptom Profile (USP) questionnaire
Time Frame: At 6 weeks
|
Score will be measured after study drug treatment initiation.
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At 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Renaud de Crevoisier, MD, Centre Eugène Marquis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Genital Neoplasms, Male
- Prostatic Diseases
- Urinary Bladder, Overactive
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Solifenacin Succinate
Other Study ID Numbers
- 2014-RdC-PRO-Th
- 2014-004296-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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