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

• Status: Withdrawn
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

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).