Clinical trial · Interventional
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
H-25362: Effect of Botulinum Neurotoxin Type A Prostate Injections on Neurogenesis and Gene Profile Expression in Men With Localized Prostate Cancer and Lower Urinary Tract Symptoms/BPH (Protocol # 05-09-30-03)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Enlarged Prostate With Lower Urinary Tract Symptoms (LUTS) | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BOTOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BOTOX Injection
- description
- 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).
- interventionNames
- Drug: BOTOX
Primary outcomes (1)
- measure
- Determination the effects of BoNT-A injection on BPH and prostate cancer tissues.
- timeFrame
- 3 years
- description
- The prostate tissue taken from each lobe will be compared to determine if the injection of BOTOX has effected the genetic profile.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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).
References
Publications (3)
- BACKGROUNDChancellor MB, Smith CP: Botulinum Toxin in Urology. First Edition. New York: Springer, Aug 2011. (Book)
- BACKGROUNDSmith 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
- BACKGROUNDCrawford 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