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

NCT01520441 | Withdrawn Early Phase 1 DMC

• 1 other identifier: H-25362
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer; Benign Prostatic Hyperplasia; Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS)

Keywords

Botulinum Toxin; Prostate Cancer; BPH; LUTS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Determination of BOTOX prostate injection on vas deferens tissue

  3 years

Study Arms (1)

BOTOX Injection

EXPERIMENTAL

A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml).

Drug: BOTOX

Interventions

BOTOX DRUG

A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml).

Also known as: onabotulinumtoxinA

BOTOX Injection

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Houston - Medical School

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Chancellor MB, Smith CP: Botulinum Toxin in Urology. First Edition. New York: Springer, Aug 2011. (Book)

  BACKGROUND

• 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.

  PMID: 19268490 BACKGROUND

• 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.

  PMID: 21791356 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Gusatavo E. Ayala, MD

  University of Texas Houston Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Distinguished Chair in Pathology and Laboratory Medicine

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 30, 2012
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)