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Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355185
First Posted: May 18, 2011
Last Update Posted: October 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Association of Radiation Oncology
Sanofi
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  Purpose
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.

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at an academic institution (tertiary centre ...Cross Cancer Institute) for consideration of prostate brachytherapy
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355185


Contacts
Contact: Nawaid Usmani, MD, FRCPC 780-432-8518 Nawaid.Usmani@albertahealthservices.ca
Contact: Ronald Sloboda, PhD 780-432-8719 Ron.Sloboda@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Nawaid Usmani, MD, FRCPC    780-432-8518    Nawaid.Usmani@albertahealthservices.ca   
Contact: Ron Sloboda, PHD    780-432-8719    Ron.Sloboda@albertahealthservices.ca   
Principal Investigator: Nawaid Usmani         
Sponsors and Collaborators
AHS Cancer Control Alberta
Canadian Association of Radiation Oncology
Sanofi
Investigators
Principal Investigator: Nawaid Usmani, MD, FRCPC University of Alberta
Principal Investigator: Ronald Sloboda, PhD University of Alberta
  More Information

Publications:
Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01355185     History of Changes
Other Study ID Numbers: 25750
First Submitted: May 16, 2011
First Posted: May 18, 2011
Last Update Posted: October 3, 2014
Last Verified: October 2014

Keywords provided by AHS Cancer Control Alberta:
Seed movement
implants
prostate brachytherapy
localized