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Continuous Monitoring of Prostate Position During Radiotherapy (KIM Gating)

This study is currently recruiting participants.
Verified August 2016 by Associate Professor Thomas Eade, Royal North Shore Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742403
First Posted: December 5, 2012
Last Update Posted: May 3, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Associate Professor Thomas Eade, Royal North Shore Hospital
  Purpose
This study is investigating measurement of prostate motion during radiotherapy using the implanted gold markers. If motion is greater than 3mm then the beam will be stopped and position corrected (gating).

Condition Intervention
Prostate Cancer Radiation: R/T gating kV intrafraction monitoring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)

Resource links provided by NLM:


Further study details as provided by Associate Professor Thomas Eade, Royal North Shore Hospital:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 2 years ]
    Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time.


Secondary Outcome Measures:
  • Time for procedure [ Time Frame: 2 years ]
    Measurement of time taken to perform KIM gating to guide future department resource questions.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R/T gating kV intrafraction monitoring

Intervention: Recruitment will be performed in 2 phases:

Phase I will include the first 10 patients. All patients will be treated on a standard fractionation protocol with 40 fractions. This will allow 400 potential fractions to be auto-segmented in real time. Once Phase I is successfully completed we will aim to continue recruitment of a further 20 patients as Phase II. For this phase we will open recruitment to patients with lymph node positivity, hypofractionation (as per Department protocols) and intermittent imaging (imaging less frequently than every fraction).

Radiation: R/T gating kV intrafraction monitoring
This is a Phase I Pilot study to assess the feasibility of implementing prostate radiotherapy gating using kV intrafraction monitoring.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing definitive external beam radiotherapy;
  • Histological proven prostate adenocarcinoma
  • Prostate Specific Antigen (PSA),within 3 months prior to enrolment
  • Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be approved for procedure by Cardiologist)
  • Artificial hips
  • Lymph Node irradiation
  • Patient Dimensions >40cms
  • ECOG 0-2
  • Ability to understand and willingness to sign informed consent form.

Exclusion Criteria:

  • Altered fractionation
  • Fiducials must be no less than 1cm apart
  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): NCT01742403


Contacts
Contact: Thomas N Eade, MBBS +61294631319 TEade@nsccahs.health.nsw.gov.au
Contact: Jeremy Booth, PhD +61294631320 JBooth@nsccahs.health.nsw.gov.au

Locations
Australia, New South Wales
Department of Radiation Oncology, Northern Sydney Cancer Centre Recruiting
St. Leonards, New South Wales, Australia, 2065
Contact: Thomas N Eade, MBBS    +61294631315    Thomas.Eade@health.nsw.gov.au   
Contact: Clare Banks, MPH    +61 2 9463 1345    Clare.Banks@health.nsw.gov.au   
Principal Investigator: Thomas N Eade, RANZCR I & II         
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
Principal Investigator: Thomas Eade, MBBS Royal North Shore Hospital
  More Information

Publications:
Responsible Party: Associate Professor Thomas Eade, Radiation Oncologist, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT01742403     History of Changes
Other Study ID Numbers: 12-NSCCRO-P001
First Submitted: December 2, 2012
First Posted: December 5, 2012
Last Update Posted: May 3, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: With other ethics approved centres using annonymised data.

Keywords provided by Associate Professor Thomas Eade, Royal North Shore Hospital:
Prostate
IGRT
VMAT

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