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Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer (VesiCaP)

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Succinate of Solifenacin
Placebo of Succinate of Solifenacin
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinique Pasteur Lanroze
  • CH Bretagne Sud
  • CH Lyon Sud
  • Hôpital Saint Louis
  • Centre Eugene Marquis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Succinate of Solifenacin

Placebo of Succinate of Solifenacin

Arm Description

1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months.

1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months.

Outcomes

Primary Outcome Measures

Score of Urinary Symptom Profile (USP) questionnaire
Score will be measured after study drug treatment initiation.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2016
Last Updated
January 18, 2018
Sponsor
Center Eugene Marquis
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1. Study Identification

Unique Protocol Identification Number
NCT02805452
Brief Title
Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
Acronym
VesiCaP
Official Title
Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Target of recruitment not reachable
Study Start Date
July 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Succinate of Solifenacin
Arm Type
Experimental
Arm Description
1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months.
Arm Title
Placebo of Succinate of Solifenacin
Arm Type
Placebo Comparator
Arm Description
1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months.
Intervention Type
Drug
Intervention Name(s)
Succinate of Solifenacin
Intervention Type
Drug
Intervention Name(s)
Placebo of Succinate of Solifenacin
Primary Outcome Measure Information:
Title
Score of Urinary Symptom Profile (USP) questionnaire
Description
Score will be measured after study drug treatment initiation.
Time Frame
At 6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud de Crevoisier, MD
Organizational Affiliation
Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Pasteur Lanroze
City
Brest
Country
France
Facility Name
CH Bretagne Sud
City
Lorient
Country
France
Facility Name
CH Lyon Sud
City
Lyon
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer

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