Clinical trial · Interventional
VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate
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
NCT01777217CI-TRIAL-00016633terminatedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Over-Active Bladder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Solifenacin succinate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- solifenacin succinate
- description
- Solifenacin succinate, 5mg or 10 mg once daily
- interventionNames
- Drug: Solifenacin succinate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Drug: Placebo oral
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
- timeFrame
- baseline and 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDKuban 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. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31. PMID 17765406
- BACKGROUNDIkeda 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. doi: 10.1007/s00210-002-0554-x. Epub 2002 Jun 14. PMID 12122494
- BACKGROUNDMichalski 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. doi: 10.1016/s0360-3016(99)00443-5. PMID 10661346
- BACKGROUNDPeeters 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. doi: 10.1200/JCO.2005.05.2530. PMID 16648499
- BACKGROUNDZelefsky 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. PMID 18280056
- BACKGROUNDZietman 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. doi: 10.1001/jama.294.10.1233.