Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer (VesiCaP)
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|ClinicalTrials.gov Identifier: NCT02805452|
Recruitment Status : Terminated (Target of recruitment not reachable)
First Posted : June 20, 2016
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: Succinate of Solifenacin Drug: Placebo of Succinate of Solifenacin||Phase 3|
A multicenter Phase III, randomized, double-blinded, parallel group placebo-controlled study.
- 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).
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.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- Score of Urinary Symptom Profile (USP) questionnaire [ Time Frame: At 6 weeks ]Score will be measured after study drug treatment initiation.
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
|Clinique Pasteur Lanroze|
|CH Bretagne Sud|
|CH Lyon Sud|
|Hôpital Saint Louis|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Principal Investigator:||Renaud de Crevoisier, MD||Centre Eugène Marquis|