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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Iodine 125 standard loose brachytherapy seeds; Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant

• Registration Number: NCT01174017
• Lead Sponsor: British Columbia Cancer Agency

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.

Study Timeline

• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-08-02
• Study First Posted: 2010-08-03
• Study Start: 2010-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard loose Iodine 125 seeds	Iodine 125 standard loose brachytherapy seeds	Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds
AnchorSeed Iodine 125 implant	AnchorSeed Iodine 125 brachytherapy prostate implant	Prostate brachytherapy implant to be performed with a new design of Iodine 125 seed that has a coating to increase adherence to tissue

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Center for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada