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

Prostate Cancer Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174017
• Other study ID #: H10-01685
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2010
• Last updated: February 8, 2013
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Iodine 125 standard loose brachytherapy seeds
radioactivity 0.4 U per seed, prescribed dose 144 Gy
• AnchorSeed Iodine 125 brachytherapy prostate implant
activity 0.4 U per seed, prescribed dose 144 Gy

Locations

Country	Name	City	State
Canada	Cancer Center for the Southern Interior	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	Biocompatibles UK Ltd

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seed displacement	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	one month	No