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

British Columbia Cancer Agency

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Radiation: Iodine 125 standard loose brachytherapy seeds; Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01174017

H10-01685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Standard loose Iodine 125 seeds

Active Comparator group

Description:

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

Treatment:

Radiation: Iodine 125 standard loose brachytherapy seeds

AnchorSeed Iodine 125 implant

Experimental group

Description:

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

Treatment:

Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant