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

July 30, 2010
February 8, 2013
September 2010
December 2011   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01174017 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate
A Study Assessing the Ability of AnchorSeed Iodine-125 Sources to Hold Fast in Tissue When Implanted for Treatment of Localized Prostate Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • 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
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.
 
Completed
41
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Male
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01174017
H10-01685
No
Juanita Crook, British Columbia Cancer Agency
British Columbia Cancer Agency
Biocompatibles UK Ltd
Not Provided
British Columbia Cancer Agency
February 2013

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