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OpenTrials
Completed

NCT Number: NCT01174017

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Center for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodine 125 standard loose brachytherapy seeds

Radiation

radioactivity 0.4 U per seed, prescribed dose 144 Gy

Other names: BrachySciences

AnchorSeed Iodine 125 brachytherapy prostate implant

Radiation

activity 0.4 U per seed, prescribed dose 144 Gy

Other names: BrachySciences

Primary outcomes

  1. seed displacement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • Biocompatibles UK Ltd

Registry information

Official study title

A Study Assessing the Ability of AnchorSeed Iodine-125 Sources to Hold Fast in Tissue When Implanted for Treatment of Localized Prostate Cancer

Acronym: FAST

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 3, 2010
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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