A Study to Measure Needle Bending and Changes in Prostate Shape During a Prostate Seed Implant

This study is currently recruiting participants.
Verified December 2012 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01437085
First received: September 19, 2011
Last updated: December 10, 2012
Last verified: December 2012

September 19, 2011
December 10, 2012
October 2011
January 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01437085 on ClinicalTrials.gov Archive Site
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A Study to Measure Needle Bending and Changes in Prostate Shape During a Prostate Seed Implant
Quantifying Needle Deflection and Tissue Deformation in Transperineal Interstitial Permanent Prostate Brachytherapy: A Basis for Development of Next-Generation Implant Technique

Prostate brachytherapy is an effective treatment option for men with localized prostate cancer, with excellent cure rates and a favorable toxicity profile. With the current needle insertion technique, seed placement inaccuracy is primarily caused by needle deflection and soft tissue deformation, which both occur during the brachytherapy operation. This study will accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of ultrasound images, video clips and one CT scan.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients having a prostate brachytherapy implant at the Cross Cancer Institute.

Prostate Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prostate cancer
  • Treated with prostate brachytherapy at the Cross Cancer Institute
  • Low and intermediate risk prostate cancer
  • ambulatory patients
  • stable medical condition
  • Over 18 years of age
  • Capable of giving informed consent

Exclusion Criteria:

  • Any hormonal therapy
Male
18 Years and older
No
Contact: Nawaid Usmani, MD, FRCPC 780-432-8518 Nawaid.Usmani@albertahealthservices.ca
Contact: Wendy Read 780-432-8475 Wendy.Reid@albertahealthservices.ca
Canada
 
NCT01437085
25837
No
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Not Provided
Principal Investigator: Nawaid Usmani, MD, FRCPC University of Alberta
AHS Cancer Control Alberta
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP