drugset / Trial / NCT01520441
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2011-03
- Primary completion
- 2014-03
- Completion
- 2014-03
Publications
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 200 iu | Other |