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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01174017

Acronym

FAST

Enrollment

Registered

2010-08-03

Start date

2010-09-30

Completion date

2011-12-31

Last updated

2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, Iodine 125 brachytherapy, seed migration, seed migration in the first month after brachytherapy

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.

Interventions

RADIATIONIodine 125 standard loose brachytherapy seeds

radioactivity 0.4 U per seed, prescribed dose 144 Gy

RADIATIONAnchorSeed Iodine 125 brachytherapy prostate implant

activity 0.4 U per seed, prescribed dose 144 Gy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026