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

NCT ID: NCT01174017

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard loose Iodine 125 seeds

Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds

Group Type: ACTIVE_COMPARATOR

Iodine 125 standard loose brachytherapy seeds

Intervention Type: RADIATION

radioactivity 0.4 U per seed, prescribed dose 144 Gy

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

Group Type: EXPERIMENTAL

AnchorSeed Iodine 125 brachytherapy prostate implant

Intervention Type: RADIATION

activity 0.4 U per seed, prescribed dose 144 Gy

Interventions

Iodine 125 standard loose brachytherapy seeds

radioactivity 0.4 U per seed, prescribed dose 144 Gy

Intervention Type: RADIATION

AnchorSeed Iodine 125 brachytherapy prostate implant

activity 0.4 U per seed, prescribed dose 144 Gy

Intervention Type: RADIATION

Other Intervention Names

BrachySciences; BrachySciences

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Biocompatibles UK Ltd

INDUSTRY

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Juanita Crook

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Center for the Southern Interior

Kelowna, British Columbia, Canada

Countries

Canada

References

Badwan HO, Shanahan AE, Adams MA, Shanahan TG, Mueller PW, Markwell SJ, Tarter TH. AnchorSeed for the reduction of source movement in prostate brachytherapy with the Mick applicator implant technique. Brachytherapy. 2010 Jan-Mar;9(1):23-6. doi: 10.1016/j.brachy.2009.07.002. Epub 2009 Sep 17.

Reference Type: BACKGROUND

PMID: 19762286 (View on PubMed)

Other Identifiers

H10-01685

Identifier Type: -

Identifier Source: org_study_id