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
  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:

Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437085

Contacts
Contact: Nawaid Usmani, MD, FRCPC 780-432-8518 Nawaid.Usmani@albertahealthservices.ca
Contact: Wendy Read 780-432-8475 Wendy.Reid@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Ron Sloboda, PhD         
Sub-Investigator: Mahdi Tavakoli, PhD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Nawaid Usmani, MD, FRCPC University of Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01437085     History of Changes
Other Study ID Numbers: 25837
Study First Received: September 19, 2011
Last Updated: December 10, 2012
Health Authority: Canada: Health Canada

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

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 April 17, 2014