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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This study has been withdrawn prior to enrollment.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

May 19, 2008
November 19, 2013
Not Provided
July 2012   (final data collection date for primary outcome measure)
Urinary symptoms [ Time Frame: Weekly for 4 weeks, monthly thereafter until 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681148 on ClinicalTrials.gov Archive Site
PSA [ Time Frame: 1 mo, 3 mo, 6 mo, 9 mo, 1 year, 15 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Botulinum Toxin Injection With Prostate Brachytherapy
Botulinum Toxin Injection With Prostate Brachytherapy: A Randomized, Placebo-controlled Study Monitoring Urinary Symptoms and PSA

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Prostate Cancer
  • Lower Urinary Tract Symptoms
  • Radioactive Seed Implantation
  • 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
  • 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
  • Experimental: A
    Botox injection
    Intervention: Drug: Botox injection
  • Placebo Comparator: B
    Saline injection
    Intervention: Drug: Saline injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Biopsy proven prostate cancer undergoing brachytherapy

Exclusion Criteria:

  • Prior allergic reaction to botulinum toxin
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681148
IRB00009836
No
Peter T. Nieh, Emory University
Emory University
Not Provided
Principal Investigator: Peter T Nieh, MD Emory University SOM
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP