BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)

Withdrawn before enrolling · Early Phase 1

Conditions studied: Prostate Cancer, Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)

In brief

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.

Key facts

Study ID: NCT01520441
Run by: The University of Texas Health Science Center, Houston
People needed: 0
Starts: 2011-03-01
Expected to finish: 2014-03-01
Last updated by the study team: 2015-06-03

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

University of Texas Houston - Medical School — Houston, Texas, United States

Full record on ClinicalTrials.gov

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