Clinical Trial Details

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Study ID H-25362
Investigator
Gusatavo E. Ayala, MD,   University of Texas Houston Health Science Center
Title BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
Conditions Prostate Cancer
Benign Prostatic Hyperplasia
Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)
Interventions Drug: BOTOX
Phase Phase 0
Purpose This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.
Eligibility Ages Eligible: 50 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Biopsy proven, clinically localized prostate cancer
  • Low risk for recurrence defined as a Kattan nomogram score of less than 115, or a serum PSA < 10ng/ml, or an individual Gleason grade of 3 or lower, or clinical stage T2b or below.
  • Candidates diagnosed with localized prostate cancer must have agreed to radical prostatectomy.
  • Voided volume greater than or equal to 125 ml.
  • Maximum urinary flow less than 15 ml/sec.
  • American Urological Association (AUA) symptom severity score greater than or equal to 8.
  • Patient signed informed consent prior to the performance of any study procedures.
  • Patient able to complete the study protocol in the opinion of the investigator. Exclusion Criteria:
  • Any prior surgical intervention for BPH.
  • Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH).
  • History of bladder stones.
  • Overactive bladder without bladder outlet obstruction.
  • Enrolled in another treatment trial for any disease within the past 30 days.
  • Previous exposure to botulinum toxin.
  • Post void residual greater than 350 ml.
  • Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (based on local institutional values).
  • Daily use of a pad or device for incontinence required.
  • Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months.
  • On aminoglycosides or any drug that interfere with neuromuscular transmission.
  • Eaton-Lambert syndrome, hemophilia, hereditary clotting factors deficiency, or bleeding diathesis.
  • Penile prosthesis or artificial urinary sphincter.
  • History or current evidence of carcinoma of the bladder; pelvic radiation, hormonal treatment or surgery; urethral stricture; or bladder neck obstruction.
  • Known primary neurologic conditions such as multiple sclerosis, myasthenia gravis or Parkinson's disease, or other neurological diseases known to affect bladder function.
  • Two documented urinary tract infections of any type in the past year (UTI defined as greater than 100,000 colonies per ml urine from midstream clean catch or catheterized specimen).
  • Patients must be off aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), and Coumadin for 7 or more days prior to botulinum toxin injection.
  • Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, hypersensitivity to botulinum toxin or anesthetics used in the study, syncope, uncontrolled diabetes.
  • Patients will be excluded if they have depressed hematopoietic functions (platelet count <100,000/cm3, hemoglobin <8,5 mg/dl; absolute neutrophil count <1000/cm3).
  • Study Location
    University of Texas Houston - Medical School
    Houston, Texas, 77030
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 10/25/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01520441


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