NCT02805452

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Center Eugene Marquis · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Succinate of Solifenacin
DRUG	Placebo of Succinate of Solifenacin

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-30
• Completion: 2017-07-15
• First posted: 2016-06-20
• Last updated: 2018-01-19

Locations

5 sites across 1 country: France