Prostate CancerNCT01355185
Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences
An observational study of Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Jun 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen at an academic institution (tertiary centre ...Cross Cancer Institute) for consideration of prostate brachytherapy
Who may be able to join
- treated with prostate brachytherapy
- low risk or intermediate risk prostate cancer
- ambulatory
- stable medical condition
- 18 years of age or older
- capable of informed consent
Who cannot join
- no use of any hormonal therapy
- unable to have MRI scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Nawaid Usmani, MD, FRCPC, 780-432-8518, Nawaid.Usmani@albertahealthservices.ca
Ron Sloboda, PHD, 780-432-8719, Ron.Sloboda@albertahealthservices.ca
About this study
There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.
Read the detailed description
Prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile. Having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.
- Conditions
- Prostate Cancer
- Keywords
- Seed movement, implants, prostate brachytherapy, localized
- Medical subject headings
- Prostatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology, Sanofi
- Responsible party
- Sponsor
- Investigators
- Nawaid Usmani, MD, FRCPC, Principal investigator, University of AlbertaRonald Sloboda, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355185
- Sponsor's protocol ID
- 25750
- Status last verified
- Oct 2014
- First submitted
- 16 May 2011
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sloboda RS, Usmani N, Pedersen J, Murtha A, Pervez N, Yee D. Time course of prostatic edema post permanent seed implant determined by magnetic resonance imaging. Brachytherapy. 2010 Oct-Dec;9(4):354-61. doi: 10.1016/j.brachy.2009.09.008. Epub 2010 Jan 29.
PubMed 20116344
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences
- ClinicalTrials.gov ID
- NCT01355185
- Acronym / sponsor ID
- 25750
- Conditions
- Prostate Cancer
- Keywords
- Seed movement, implants, prostate brachytherapy, localized
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology, Sanofi
- Study start
- Aug 2011
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 May 2011 (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.
There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.
Detailed description
Prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile. Having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen at an academic institution (tertiary centre ...Cross Cancer Institute) for consideration of prostate brachytherapy
Key inclusion criteria (6 listed)
- treated with prostate brachytherapy
- low risk or intermediate risk prostate cancer
- ambulatory
- stable medical condition
- 18 years of age or older
Key exclusion criteria (2 listed)
- no use of any hormonal therapy
- unable to have MRI scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Background: PubMed 20116344Sloboda RS, Usmani N, Pedersen J, Murtha A, Pervez N, Yee D. Time course of prostatic edema post permanent seed implant determined by magnetic resonance imaging. Brachytherapy. 2010 Oct-Dec;9(4):354-61. doi: 10.1016/j.brachy.2009.09.008. Epub 2010 Jan 29.
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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.
Nawaid Usmani, MD, FRCPC principal investigator
University of Alberta
Ronald Sloboda, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by AHS Cancer Control Alberta 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Oct 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nawaid Usmani, MD, FRCPC (780-432-8518, Nawaid.Usmani@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355185, 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 3 Oct 2014.