NCT00681148

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

First QC Date

May 19, 2008

Last Update Submit

November 19, 2013

Conditions

Prostate CancerLower Urinary Tract SymptomsRadioactive Seed Implantation

Keywords

Prostate specific antigen (PSA)Prostate cancerLower urinary tract symptomsRadioactive seed implantation

Outcome Measures

Primary Outcomes (1)

  • Urinary symptoms

    Weekly for 4 weeks, monthly thereafter until 1 year

Secondary Outcomes (1)

  • PSA

    1 mo, 3 mo, 6 mo, 9 mo, 1 year, 15 mo, 18 mo, 24 mo

Study Arms (2)

A

EXPERIMENTAL

Botox injection

Drug: Botox injection

B

PLACEBO COMPARATOR

Saline injection

Drug: Saline injection

Interventions

Botox injectionDRUG

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.

Also known as: Botox
A
Saline injectionDRUG

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.

Also known as: NS
B

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven prostate cancer undergoing brachytherapy

You may not qualify if:

  • Prior allergic reaction to botulinum toxin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Clinic, Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (5)

  • Lee WR, Hall MC, McQuellon RP, Case LD, McCullough DL. A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):614-23. doi: 10.1016/s0360-3016(01)01707-2.

    PMID: 11597800BACKGROUND

  • Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. doi: 10.1016/s0360-3016(03)01448-2.

    PMID: 14630265BACKGROUND

  • Ansiaux R, Baudelet C, Cron GO, Segers J, Dessy C, Martinive P, De Wever J, Verrax J, Wauthier V, Beghein N, Gregoire V, Buc Calderon P, Feron O, Gallez B. Botulinum toxin potentiates cancer radiotherapy and chemotherapy. Clin Cancer Res. 2006 Feb 15;12(4):1276-83. doi: 10.1158/1078-0432.CCR-05-1222.

    PMID: 16489084BACKGROUND

  • Chuang YC, Chancellor MB. The application of botulinum toxin in the prostate. J Urol. 2006 Dec;176(6 Pt 1):2375-82. doi: 10.1016/j.juro.2006.07.127.

    PMID: 17085104BACKGROUND

  • Chuang YC, Huang CC, Kang HY, Chiang PH, Demiguel F, Yoshimura N, Chancellor MB. Novel action of botulinum toxin on the stromal and epithelial components of the prostate gland. J Urol. 2006 Mar;175(3 Pt 1):1158-63. doi: 10.1016/S0022-5347(05)00318-6.

    PMID: 16469644BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsLower Urinary Tract Symptoms

Interventions

Botulinum Toxins, Type ASodium Chloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Peter T Nieh, MD

    Emory University SOM

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

US(1)