Prostate CancerPhase 3FASTNCT01174017
Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate
A Phase 3 study testing Iodine 125 standard loose brachytherapy seeds and AnchorSeed Iodine 125 brachytherapy prostate implant in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Iodine 125 standard loose brachytherapy seeds and AnchorSeed Iodine 125 brachytherapy prostate implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- localized prostate cancer
- favorable or intermediate risk
- suitable for permanent seed implant by functional and technical criteria
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Cancer Center for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
About this study
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
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.
Read the 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
- Being tested
- Iodine 125 standard loose brachytherapy seeds, AnchorSeed Iodine 125 brachytherapy prostate implant
- Keywords
- prostate cancer, Iodine 125 brachytherapy, seed migration, seed migration in the first month after brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine 125 standard loose brachytherapy seedsRadiation
Also called BrachySciences
radioactivity 0.4 U per seed, prescribed dose 144 Gy
AnchorSeed Iodine 125 brachytherapy prostate implantRadiation
Also called BrachySciences
activity 0.4 U per seed, prescribed dose 144 Gy
| Study group | Role | What they receive |
|---|---|---|
| Standard loose Iodine 125 seeds | Active comparator | Prostate brachytherapy implant to be performed with standard format loose Iodine 125 seeds Receives: 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 Receives: Radiation: AnchorSeed Iodine 125 brachytherapy prostate implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Responsible party
- Principal investigator, Juanita Crook, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174017
- Sponsor's protocol ID
- H10-01685
- Acronym
- FAST
- Status last verified
- Feb 2013
- First submitted
- 30 Jul 2010
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19762286
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01174017
- Acronym / sponsor ID
- FAST / H10-01685
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, Iodine 125 brachytherapy, seed migration, seed migration in the first month after brachytherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard loose Iodine 125 seeds | Active comparator | Radiation: Iodine 125 standard loose brachytherapy seedsProstate brachytherapy implant to be performed with standard format loose Iodine 125 seeds |
| AnchorSeed Iodine 125 implant | Experimental | Radiation: AnchorSeed Iodine 125 brachytherapy prostate implantProstate brachytherapy implant to be performed with a new design of Iodine 125 seed that has a coating to increase adherence to tissue |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- localized prostate cancer
- favorable or intermediate risk
- suitable for permanent seed implant by functional and technical criteria
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine 125 standard loose brachytherapy seedsAlso: BrachySciencesradioactivity 0.4 U per seed, prescribed dose 144 Gy | Radiation | Standard loose Iodine 125 seeds |
| AnchorSeed Iodine 125 brachytherapy prostate implantAlso: BrachySciencesactivity 0.4 U per seed, prescribed dose 144 Gy | Radiation | AnchorSeed Iodine 125 implant |
Primary outcome
seed displacement
Time frame: one month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Background: PubMed 19762286Badwan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iodine 125 standard loose brachytherapy seeds and AnchorSeed Iodine 125 brachytherapy prostate implant in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seed displacement (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01174017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.