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Continuous Monitoring of Prostate Position During Radiotherapy (KIM Gating)

This study is currently recruiting participants.
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Verified August 2016 by Associate Professor Thomas Eade, Royal North Shore Hospital
Information provided by (Responsible Party):
Associate Professor Thomas Eade, Royal North Shore Hospital Identifier:
First received: December 2, 2012
Last updated: May 1, 2017
Last verified: August 2016
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01742403

Contact: Thomas N Eade, MBBS +61294631319
Contact: Jeremy Booth, PhD +61294631320

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   
Contact: Clare Banks, MPH    +61 2 9463 1345   
Principal Investigator: Thomas N Eade, RANZCR I & II         
Sponsors and Collaborators
Royal North Shore Hospital
Principal Investigator: Thomas Eade, MBBS Royal North Shore Hospital
  More Information

Responsible Party: Associate Professor Thomas Eade, Radiation Oncologist, Royal North Shore Hospital Identifier: NCT01742403     History of Changes
Other Study ID Numbers: 12-NSCCRO-P001
Study First Received: December 2, 2012
Last Updated: May 1, 2017
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:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on September 21, 2017