Prostate Cancer Clinical Trial
Official title:
H-25362: Effect of Botulinum Neurotoxin Type A Prostate Injections on Neurogenesis and Gene Profile Expression in Men With Localized Prostate Cancer and Lower Urinary Tract Symptoms/BPH (Protocol # 05-09-30-03)
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
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). |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Houston - Medical School | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Chancellor MB, Smith CP: Botulinum Toxin in Urology. First Edition. New York: Springer, Aug 2011. (Book)
Crawford ED, Hirst K, Kusek JW, Donnell RF, Kaplan SA, McVary KT, Mynderse LA, Roehrborn CG, Smith CP, Bruskewitz R. Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol. 2011 Sep;186(3):965-70. doi: 10.1016/j.juro.2011.04.062. Epub 2011 Jul 24. — View Citation
Smith CP. Botulinum toxin in the treatment of OAB, BPH, and IC. Toxicon. 2009 Oct;54(5):639-46. doi: 10.1016/j.toxicon.2009.02.021. Epub 2009 Mar 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination the effects of BoNT-A injection on BPH and prostate cancer tissues. | The prostate tissue taken from each lobe will be compared to determine if the injection of BOTOX has effected the genetic profile. | 3 years | No |
Secondary | Determination of BOTOX prostate injection on vas deferens tissue | Any changes to the vas deferens tissue after BOTOX injection, will be noted. | 3 years | No |
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