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

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Iodine 125 standard loose brachytherapy seeds
* Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard loose Iodine 125 seeds<br>Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds | Radiation: Iodine 125 standard loose brachytherapy seeds<br>* radioactivity 0.4 U per seed, prescribed dose 144 Gy<br>* Other names: BrachySciences;|
| Experimental: AnchorSeed Iodine 125 implant<br>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<br>* activity 0.4 U per seed, prescribed dose 144 Gy<br>* Other names: BrachySciences;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, Iodine 125 brachytherapy, seed migration, seed migration in the first month after brachytherapy