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Study ID
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H-25362
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Investigator
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Christopher P. Smith, MD, Baylor College of Medicine
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Title
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BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
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Conditions
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Prostate Cancer
Benign Prostatic Hyperplasia
Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)
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Interventions
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Drug: BOTOX
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Phase
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Phase 0
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Purpose
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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.
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Eligibility
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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).
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Study Location
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N/A
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Contact
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Sebrina Tello, CMA
713-798-8106
stello@bcm.edu
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Information obtained from ClinicalTrials.gov, on
6/18/2013. 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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