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


Phase 3
40 Years
80 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

seed displacement

Outcome Description:

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

Outcome Time Frame:

one month

Safety Issue:

No

Authority:

Canada: Ethics Review Committee

Study ID:

H10-01685

NCT ID:

NCT01174017

Start Date:

September 2010

Completion Date:

December 2011

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Iodine 125 brachytherapy
  • seed migration
  • seed migration in the first month after brachytherapy
  • Prostatic Neoplasms

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