NCT01174017

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Iodine 125 standard loose brachytherapy seeds	radioactivity 0.4 U per seed, prescribed dose 144 Gy
RADIATION	AnchorSeed Iodine 125 brachytherapy prostate implant	activity 0.4 U per seed, prescribed dose 144 Gy

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-08-03
• Last updated: 2013-02-12

Locations

1 site across 1 country: Canada