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

Sponsor

British Columbia Cancer Agency (Other)

Overall Status

Completed

CT.gov ID

NCT01174017

Collaborator

Biocompatibles UK Ltd (Industry)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Iodine 125 standard loose brachytherapy seeds Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard loose Iodine 125 seeds Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds	Radiation: Iodine 125 standard loose brachytherapy seeds radioactivity 0.4 U per seed, prescribed dose 144 Gy Other Names: BrachySciences
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	Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant activity 0.4 U per seed, prescribed dose 144 Gy Other Names: BrachySciences

Arm

Intervention/Treatment

Active Comparator: Standard loose Iodine 125 seeds

Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds

Radiation: Iodine 125 standard loose brachytherapy seeds

radioactivity 0.4 U per seed, prescribed dose 144 Gy

Other Names:

BrachySciences

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

Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant

activity 0.4 U per seed, prescribed dose 144 Gy

Other Names:

BrachySciences

Outcome Measures

Primary Outcome Measures

seed displacement [one month]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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