VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

NCT01777217 | Terminated Phase 4 Results DMC

• 1 other identifier: VESI-12J03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Over-Active Bladder

Keywords

Urination Disorder; Overactive Bladder; Prostate Cancer Radiation; Vesicare

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).

  The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.

  baseline and 16 weeks

Study Arms (2)

solifenacin succinate

ACTIVE COMPARATOR

Solifenacin succinate, 5mg or 10 mg once daily

Drug: Solifenacin succinate

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral

Drug: Placebo

Interventions

Solifenacin succinate DRUG

IGRT with VESIcare

Also known as: VESIcare

solifenacin succinate

Placebo DRUG

IGRT with placebo

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Subject must be an ambulatory male at least 18 years of age.
• Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy.
• Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire.

You may not qualify if:

• Subject has undergone a prostatectomy
• Subject exhibits symptoms of urinary tract infection.
• Subject exhibits severe neurologic damage or has undergone prostatectomy.
• Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit.
• Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI.
• Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents.
• Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure.
• Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
• Subjects with co-morbid lower urinary tract symptoms (LUTS).
• Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
• 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.
• Subjects who have received prior pelvic radiation.
• Subjects with history of severe hepatic impairment.
• Subjects with history of Congenital or Acquired QT prolongation.

Sponsors & Collaborators

• Advanced Research Network: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Century Cancer Center

Houston, Texas, 77025, United States

Location

Related Publications (7)

• 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. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.

  PMID: 17765406 BACKGROUND

• 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. doi: 10.1007/s00210-002-0554-x. Epub 2002 Jun 14.

  PMID: 12122494 BACKGROUND

• 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. doi: 10.1016/s0360-3016(99)00443-5.

  PMID: 10661346 BACKGROUND

• 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. doi: 10.1200/JCO.2005.05.2530.

  PMID: 16648499 BACKGROUND

• 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.

  PMID: 18280056 BACKGROUND

• 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. doi: 10.1001/jama.294.10.1233.

  PMID: 16160131 BACKGROUND

• 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. doi: 10.1002/cncr.20408.

  PMID: 15495199 BACKGROUND

MeSH Terms

Conditions

Urination Disorders; Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Sanjay Mehta
• Organization: Century Cancer Centers

713-631-8181

Study Officials

• Sanjay Mehta, M.D.

  Century Cancer Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 16, 2015
• Results First Posted: January 16, 2015

Record last verified: 2014-12

Locations

US (1)