Trial Information
Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Outcome Description:
Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Thomas Eade, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Royal North Shore Hospital
Authority:
Australia: Human Research Ethics Committee
Study ID:
12-NSCCRO-P001
NCT ID:
NCT01742403
Start Date:
January 2013
Completion Date:
December 2015
Related Keywords:
- Prostate Cancer
- Prostate
- IGRT
- VMAT
- Prostatic Neoplasms