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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
  Purpose

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 Intervention Phase
Prostate Cancer
 Radiation: Iodine 125 standard loose brachytherapy seeds
Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Iodine Iodide
U.S. FDA Resources

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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


Enrollment: 41
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: BrachySciences

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174017

Locations
Canada, British Columbia
Cancer Center for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Sponsors and Collaborators
British Columbia Cancer Agency
Biocompatibles UK Ltd
  More Information

Publications:

Responsible Party: Juanita Crook, MD, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01174017     History of Changes
Other Study ID Numbers: H10-01685
Study First Received: July 30, 2010
Last Updated: February 8, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by British Columbia Cancer Agency:
prostate cancer
Iodine 125 brachytherapy
seed migration
seed migration in the first month after brachytherapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Iodine
Cadexomer iodine
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013