Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate (FAST)

This study has been completed.

Sponsor:

Collaborator:

Biocompatibles UK Ltd

Information provided by (Responsible Party):

Juanita Crook, British Columbia Cancer Agency

ClinicalTrials.gov Identifier:

NCT01174017

First received: July 30, 2010

Last updated: February 8, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 30, 2010
Last Updated Date	February 8, 2013
Start Date ^ICMJE	September 2010
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2013)	seed displacement [ Time Frame: one month ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE (submitted: August 2, 2010)	seed displacement [ Time Frame: one month ] [ Designated as safety issue: No ] CT scan of the prostate imnmediately 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
Change History	Complete list of historical versions of study NCT01174017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate
Official Title ^ICMJE	A Study Assessing the Ability of AnchorSeed Iodine-125 Sources to Hold Fast in Tissue When Implanted for Treatment of Localized Prostate Cancer
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Radiation: Iodine 125 standard loose brachytherapy seeds radioactivity 0.4 U per seed, prescribed dose 144 Gy Other Name: BrachySciences Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant activity 0.4 U per seed, prescribed dose 144 Gy Other Name: BrachySciences
Study Arm (s)	Active Comparator: Standard loose Iodine 125 seeds Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds Intervention: Radiation: Iodine 125 standard loose brachytherapy seeds Experimental: AnchorSeed Iodine 125 implant Prostate brachytherapy implant to be performed with a new design of Iodine 125 seed that has a coating to increase adherence to tissue Intervention: Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant
Publications *	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. Epub 2009 Sep 17.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	41
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01174017
Other Study ID Numbers ^ICMJE	H10-01685
Has Data Monitoring Committee	No
Responsible Party	Juanita Crook, British Columbia Cancer Agency
Study Sponsor ^ICMJE	British Columbia Cancer Agency
Collaborators ^ICMJE	Biocompatibles UK Ltd
Investigators ^ICMJE	Not Provided
Information Provided By	British Columbia Cancer Agency
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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