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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805452
Recruitment Status : Terminated (Target of recruitment not reachable)
First Posted : June 20, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Succinate of Solifenacin Drug: Placebo of Succinate of Solifenacin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer
Actual Study Start Date : July 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Succinate of Solifenacin
1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months.
Drug: Succinate of Solifenacin
Placebo Comparator: Placebo of Succinate of Solifenacin
1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months.
Drug: Placebo of Succinate of Solifenacin



Primary Outcome Measures :
  1. Score of Urinary Symptom Profile (USP) questionnaire [ Time Frame: At 6 weeks ]
    Score will be measured after study drug treatment initiation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805452


Locations
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France
Clinique Pasteur Lanroze
Brest, France
CH Bretagne Sud
Lorient, France
CH Lyon Sud
Lyon, France
Hôpital Saint Louis
Paris, France
Centre Eugene Marquis
Rennes, France, 35042
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Principal Investigator: Renaud de Crevoisier, MD Centre Eugène Marquis
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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT02805452    
Other Study ID Numbers: 2014-RdC-PRO-Th
2014-004296-22 ( EudraCT Number )
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents