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

NCT02805452 | Terminated Phase 3

• 2 other identifiers: 2014-RdC-PRO-Th2014-004296-22
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Score of Urinary Symptom Profile (USP) questionnaire

  Score will be measured after study drug treatment initiation.

  At 6 weeks

Study Arms (2)

Succinate of Solifenacin

EXPERIMENTAL

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

Drug: Succinate of Solifenacin

Placebo of Succinate of Solifenacin

PLACEBO COMPARATOR

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

Drug: Placebo of Succinate of Solifenacin

Interventions

Succinate of Solifenacin DRUG

Succinate of Solifenacin

Placebo of Succinate of Solifenacin DRUG

Placebo of Succinate of Solifenacin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (5)

Clinique Pasteur Lanroze

Brest, France

Location

CH Bretagne Sud

Lorient, France

Location

CH Lyon Sud

Lyon, France

Location

Hôpital Saint Louis

Paris, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Renaud de Crevoisier, MD

  Centre Eugène Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 20, 2016
• Study Start: July 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: July 15, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)