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

NCT01174017 | Completed Phase 3

• 1 other identifier: H10-01685
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; Iodine 125 brachytherapy; seed migration; seed migration in the first month after brachytherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard loose Iodine 125 seeds

ACTIVE COMPARATOR

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

Radiation: Iodine 125 standard loose brachytherapy seeds

AnchorSeed Iodine 125 implant

EXPERIMENTAL

Prostate brachytherapy implant to be performed with a new design of Iodine 125 seed that has a coating to increase adherence to tissue

Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant

Interventions

Iodine 125 standard loose brachytherapy seeds RADIATION

radioactivity 0.4 U per seed, prescribed dose 144 Gy

Also known as: BrachySciences

Standard loose Iodine 125 seeds

AnchorSeed Iodine 125 brachytherapy prostate implant RADIATION

activity 0.4 U per seed, prescribed dose 144 Gy

Also known as: BrachySciences

AnchorSeed Iodine 125 implant

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• localized prostate cancer
• favorable or intermediate risk
• suitable for permanent seed implant by functional and technical criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (1)

Cancer Center for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Related 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.

  PMID: 19762286 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 3, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

CA (1)