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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01437085
First Posted: September 20, 2011
Last Update Posted: January 25, 2017
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.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  Purpose
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
Prostate Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Enrollment: 25
Study Start Date: October 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
  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:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having a prostate brachytherapy implant at the Cross Cancer Institute.
Criteria

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
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): NCT01437085


Locations
Canada, Alberta
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
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01437085     History of Changes
Other Study ID Numbers: 25837
First Submitted: September 19, 2011
First Posted: September 20, 2011
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by AHS Cancer Control Alberta:
Needle deflection
Prostate Deformation
Prostate Brachytherapy
Needles