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Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)


Phase 1
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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

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