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

Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Unknown status
CT.gov ID
NCT01437085
Collaborator
(none)
25
Enrollment
1
Location
70
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Quantifying Needle Deflection and Tissue Deformation in Transperineal Interstitial Permanent Prostate Brachytherapy: A Basis for Development of Next-Generation Implant Technique
    Study Start Date :
    Oct 1, 2011
    Anticipated Primary Completion Date :
    Aug 1, 2017
    Anticipated Study Completion Date :
    Aug 1, 2017

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2

      Sponsors and Collaborators

      • AHS Cancer Control Alberta

      Investigators

      • Principal Investigator: Nawaid Usmani, MD, FRCPC, University of Alberta

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      AHS Cancer Control Alberta
      ClinicalTrials.gov Identifier:
      NCT01437085
      Other Study ID Numbers:
      • 25837
      First Posted:
      Sep 20, 2011
      Last Update Posted:
      Jan 25, 2017
      Last Verified:
      Jan 1, 2017
      Keywords provided by AHS Cancer Control Alberta
      Needle deflection
      Prostate Deformation
      Prostate Brachytherapy
      Needles
      Additional relevant MeSH terms:
      Prostatic Neoplasms

      Study Results

      No Results Posted as of Jan 25, 2017