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

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Collaborators:
Canadian Association of Radiation Oncology
Sanofi
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01355185
First received: May 16, 2011
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Alberta Health Services
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: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01355185     History of Changes
Other Study ID Numbers: 25750
Study First Received: May 16, 2011
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
Seed movement
implants
prostate brachytherapy
localized

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013