Status:
WITHDRAWN
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Prostate Cancer
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
EARLY_PHASE1
Brief Summary
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 Tra...
Detailed Description
For the purposes of this study, patients are treated with the presentation of botulinum toxin type A which is marketed in the U.S. as BOTOX® by Allergan. BOTOX® is a purified neurotoxin complex suppli...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01520441
Start Date
March 1 2011
End Date
March 1 2014
Last Update
June 3 2015
Active Locations (1)
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1
University of Texas Houston - Medical School
Houston, Texas, United States, 77030