Continuous Monitoring of Prostate Position During Radiotherapy (KIM Gating)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Royal North Shore Hospital
Sponsor:
Information provided by (Responsible Party):
Associate Professor Thomas Eade, Royal North Shore Hospital
ClinicalTrials.gov Identifier:
NCT01742403
First received: December 2, 2012
Last updated: July 12, 2015
Last verified: July 2015
  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 Phase
Prostate Cancer
Radiation: R/T gating kV intrafraction monitoring
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Royal North Shore Hospital:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measurement of time taken to perform KIM gating to guide future department resource questions.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: January 2016 (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

Genders 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)
  • ECOG 0-2
  • Ability to understand and willingness to sign informed consent form.

Exclusion Criteria:

  • Lymph node irradiation
  • Altered fractionation
  • Artificial hip(s)
  • Patient Dimensions <50cm
  • Overlapping fiducials (for segmentation)
  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 ClinicalTrials.gov identifier: 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: Natalie Plant, M.Sc.    +61 2 9463 1340    Natalie.Plant@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

No publications provided

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
Study First Received: December 2, 2012
Last Updated: July 12, 2015
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal North Shore Hospital:
Prostate
IGRT
VMAT

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

ClinicalTrials.gov processed this record on September 02, 2015