Botulinum Toxin Injection With Prostate Brachytherapy

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
Information provided by (Responsible Party):
Peter T. Nieh, Emory University
ClinicalTrials.gov Identifier:
NCT00681148
First received: May 19, 2008
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to see if botox injection into the prostate during seed implantation (brachytherapy) for prostate cancer a) improves urinary symptoms or avoids need for urinary tract instrumentation over the 6-8 month post-operative period when one wants to avoid manipulating the radioactive seeds, and b) speeds up the drop in PSA. Patients will be randomized to botox vs saline injection, at the completion of the seed implantation procedure.


Condition Intervention Phase
Prostate Cancer
Lower Urinary Tract Symptoms
Radioactive Seed Implantation
Drug: Botox injection
Drug: Saline injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Injection With Prostate Brachytherapy: A Randomized, Placebo-controlled Study Monitoring Urinary Symptoms and PSA

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Urinary symptoms [ Time Frame: Weekly for 4 weeks, monthly thereafter until 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA [ Time Frame: 1 mo, 3 mo, 6 mo, 9 mo, 1 year, 15 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]

Enrollment: 0
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Botox injection
Drug: Botox injection
Intraprostatic injection of Botox (100 units for < 30 cc prostate; 200 units for > 30 cc prostate) administering 2 transperineal injections into both lateral lobes of the prostate (25-50 units per injection), just 5-10 mm proximal to the bladder neck.
Other Name: Botox
Placebo Comparator: B
Saline injection
Drug: Saline injection
Saline injection, administering 2 transperineal injections into both lateral lobes of the prostate (1-2 cc per injection), just 5-10 mm proximal to the bladder neck.
Other Name: NS

Detailed Description:

Brachytherapy is a popular treatment modality for localized prostate cancer, where radioactive seeds are implanted through 18 gauge needles into the prostate via a perineal template with rectal ultrasound guidance. The radioactivity is delivered over several months, depending on the isotope used. During this time, there can be exacerbation of urinary voiding symptoms from early edema of the prostate gland due to the implantation procedure, then later from the inflammatory reaction of the radiation. Because the initial acute inflammation may persist for many months despite steadily declining doses of radiation, attempts are made to minimize urinary symptoms prior to brachytherapy with pharmacologic therapy (alpha-blockers) or minimally invasive surgical therapy (transurethral incision or limited transurethral resection to avoid significant distortion of the prostate parenchyma for future seed implantation). Even with these precautions, around 30-40% of brachytherapy patients will still develop voiding symptoms. With such bothersome symptoms, intervention is deferred for at least 8-10 months to avoid distorting the planned field of radiation. Once symptoms develop, various additional pharmacologic measures are employed, such as increased doses of alpha-blockers, medrol steroid taper, and non-steroidal anti-inflammatory agents. Some patients require intermittent self-catheterization or suprapubic catheter for urinary diversion.

Botulinum toxin has been used for cosmetic uses, and has been successfully used for treatment of overactive bladder, external sphincter dyssynergia, and benign prostatic hyperplasia (BPH). The studies with BPH show reduction in symptoms scores, PSA, and prostate volume, the latter from atrophy due to the denervation effect. The response lasts for 6-9 months.

We propose to study botox intraprostatic injection during brachytherapy to see whether this improves urinary symptoms or avoids need for urinary tract instrumentation over this 6-8 month post-operative period when one wants to avoid manipulating the radioactive seeds. We will also monitor PSA, and see if there is any measurable augmentation of PSA decline with botox + Brachytherapy vs Brachytherapy alone. We will randomize patients to botox (100 units for < 30 cc prostate; 200 units for > 30 cc prostate) vs saline injection, administering 2 transperineal injections into both lateral lobes of the prostate (25-50 mg per injection), just 5-10 mm proximal to the bladder neck.

Study design:

N= 60 (30 receive Botox, 30 receive saline)

Followup:

AUA Symptoms scores weekly for 4 weeks, monthly thereafter Medications for urinary symptoms Need for catheterization PSA checked at 1 mo, 3 mo, 6 mo, 9 mo, 1 year, 15 mo, 18 mo, 24 mo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate cancer undergoing brachytherapy

Exclusion Criteria:

  • Prior allergic reaction to botulinum toxin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681148

Locations
United States, Georgia
Emory Clinic, Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Peter T Nieh, MD Emory University SOM
  More Information

Publications:
Responsible Party: Peter T. Nieh, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00681148     History of Changes
Other Study ID Numbers: IRB00009836
Study First Received: May 19, 2008
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Prostate specific antigen (PSA)
Prostate cancer
Lower urinary tract symptoms
Radioactive seed implantation

Additional relevant MeSH terms:
Prostatic Neoplasms
Lower Urinary Tract Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014