Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate (FAST)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Iodine 125 standard loose brachytherapy seeds
AnchorSeed Iodine 125 brachytherapy prostate implant
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, Iodine 125 brachytherapy, seed migration, seed migration in the first month after brachytherapy
Eligibility Criteria
Inclusion Criteria:
- localized prostate cancer
- favorable or intermediate risk
- suitable for permanent seed implant by functional and technical criteria
Exclusion Criteria:
- patient unwilling to have a second CT scan for study purposes
- claustrophobic patient unable to have CT scan
- patient unsuitable for brachytherapy because of prostate size or poor voiding function
- patient medically unable to stop anticoagulants for procedure
Sites / Locations
- Cancer Center for the Southern Interior
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard loose Iodine 125 seeds
AnchorSeed Iodine 125 implant
Arm Description
Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds
Prostate brachytherapy implant to be performed with a new design of Iodine 125 seed that has a coating to increase adherence to tissue
Outcomes
Primary Outcome Measures
seed displacement
CT scan of the prostate immediately after the implant will be used to determine the center of mass of the implant as a reference for distal migration of apical seeds and compared to positions on the CT scan one month following the implant
Secondary Outcome Measures
Full Information
NCT ID
NCT01174017
First Posted
July 30, 2010
Last Updated
February 8, 2013
Sponsor
British Columbia Cancer Agency
Collaborators
Biocompatibles UK Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01174017
Brief Title
Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate
Acronym
FAST
Official Title
A Study Assessing the Ability of AnchorSeed Iodine-125 Sources to Hold Fast in Tissue When Implanted for Treatment of Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
Biocompatibles UK Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares the ability of a new design of brachytherapy seed for prostate seed implants for treatment of prostate cancer to maintain their intended position in the prostate after being deposited. Standard seeds, especially in apical locations, have a tendency to migrate distally in response to muscular forces. AnchorSeeds have a textured coating which is designed to prevent migration. 40 patients who are eligible and suitable for prostate brachytherapy will be randomly assigned to receive either standard seeds or AnchorSeeds.
Detailed Description
Standard post implant prostate brachytherapy quality assurance at the Center for the Southern Interior is usually performed at one month after the procedure with CT and MR imaging. In order to test the ability of the new design of prostate brachytherapy seeds (AnchorSeeds) to hold their position in the prostate, 40 men who have been randomly assigned to receive either standard seeds or AnchorSeeds will have an additional CT scan immediately after the procedure to record seed position for comparison to positions one month later. The magnitude and frequency of seed displacement will be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, Iodine 125 brachytherapy, seed migration, seed migration in the first month after brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard loose Iodine 125 seeds
Arm Type
Active Comparator
Arm Description
Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds
Arm Title
AnchorSeed Iodine 125 implant
Arm Type
Experimental
Arm Description
Prostate brachytherapy implant to be performed with a new design of Iodine 125 seed that has a coating to increase adherence to tissue
Intervention Type
Radiation
Intervention Name(s)
Iodine 125 standard loose brachytherapy seeds
Other Intervention Name(s)
BrachySciences
Intervention Description
radioactivity 0.4 U per seed, prescribed dose 144 Gy
Intervention Type
Radiation
Intervention Name(s)
AnchorSeed Iodine 125 brachytherapy prostate implant
Other Intervention Name(s)
BrachySciences
Intervention Description
activity 0.4 U per seed, prescribed dose 144 Gy
Primary Outcome Measure Information:
Title
seed displacement
Description
CT scan of the prostate immediately after the implant will be used to determine the center of mass of the implant as a reference for distal migration of apical seeds and compared to positions on the CT scan one month following the implant
Time Frame
one month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
localized prostate cancer
favorable or intermediate risk
suitable for permanent seed implant by functional and technical criteria
Exclusion Criteria:
patient unwilling to have a second CT scan for study purposes
claustrophobic patient unable to have CT scan
patient unsuitable for brachytherapy because of prostate size or poor voiding function
patient medically unable to stop anticoagulants for procedure
Facility Information:
Facility Name
Cancer Center for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19762286
Citation
Badwan HO, Shanahan AE, Adams MA, Shanahan TG, Mueller PW, Markwell SJ, Tarter TH. AnchorSeed for the reduction of source movement in prostate brachytherapy with the Mick applicator implant technique. Brachytherapy. 2010 Jan-Mar;9(1):23-6. doi: 10.1016/j.brachy.2009.07.002. Epub 2009 Sep 17.
Results Reference
background
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Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate
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