VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate
Information source: Advanced Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Over-Active Bladder
Intervention: Solifenacin succinate (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Advanced Research Network Official(s) and/or principal investigator(s):
Sanjay Mehta, M.D., Principal Investigator, Affiliation: Century Cancer Centers
Summary
The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective
in treating over-active bladder symptoms during radiation therapy of the prostate.
Clinical Details
Official title: A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
Detailed description:
This is a randomized double blind placebo controlled flexible dose 12 week study. Following
screening, subjects will receive their first dose of study medication following completion
of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue
for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be
completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written
Informed Consent and privacy language as per HIPAA Authorization for the USA test
sites is obtained from subject or legally authorized representative prior to the
initiation of this study (including withdrawal of prohibited medication, if
applicable)
2. Subject must be an ambulatory male at least 18 years of age.
3. Subject has been diagnosed with prostate carcinoma and has elected to undergo
external beam radiation therapy.
4. Subject is willing to complete the American Urology Association Symptom Score (AUASS)
Questionnaire.
Exclusion Criteria:
1. Subject has undergone a prostatectomy
2. Subject exhibits symptoms of urinary tract infection.
3. Subject exhibits severe neurologic damage or has undergone prostatectomy.
4. Subject diagnosed with OAB and is being treated with medication for alleviation of
OAB symptoms within 12 months prior to the Screening Visit.
5. Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric
retention, neurogenic bladder; prostatitis, or persistent UTI.
6. Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other
anticholinergic agents.
7. Subject has undergone treatment with any investigational drug within 30 days prior to
screening procedure.
8. Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
9. Subjects with co-morbid lower urinary tract symptoms (LUTS).
10. Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
11. In the opinion of the Study Investigator, the patient has exhibited prior to the
screening or Baseline visit, a clinically significant disease or medical condition
that would exclude the subject from participating in the study.
12. Subjects who have received prior pelvic radiation.
13. Subjects with history of severe hepatic impairment.
14. Subjects with history of Congenital or Acquired QT prolongation.
Locations and Contacts
Century Cancer Center, Houston, Texas 77025, United States
Additional Information
Related publications: Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. Epub 2007 Aug 31. Ikeda K, Kobayashi S, Suzuki M, Miyata K, Takeuchi M, Yamada T, Honda K. M(3) receptor antagonism by the novel antimuscarinic agent solifenacin in the urinary bladder and salivary gland. Naunyn Schmiedebergs Arch Pharmacol. 2002 Aug;366(2):97-103. Epub 2002 Jun 14. Michalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. Zelefsky MJ, Yamada Y, Fuks Z, Zhang Z, Hunt M, Cahlon O, Park J, Shippy A. Long-term results of conformal radiotherapy for prostate cancer: impact of dose escalation on biochemical tumor control and distant metastases-free survival outcomes. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1028-33. doi: 10.1016/j.ijrobp.2007.11.066. Epub 2008 Feb 14. Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. Erratum in: JAMA. 2008 Feb 27;299(8):899-900. Bostwick DG, Burke HB, Djakiew D, Euling S, Ho SM, Landolph J, Morrison H, Sonawane B, Shifflett T, Waters DJ, Timms B. Human prostate cancer risk factors. Cancer. 2004 Nov 15;101(10 Suppl):2371-490. Review.
Starting date: February 2013
Last updated: January 8, 2015
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